Preview Newsletter
Ethicon Media Monitoring 8/7/2017
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Latest J&J Pelvic Mesh Injury Case Kicks Off In Philly
Aug 4, 2017 | Law 360
By Matt Fair
The latest in a slew of cases over a Johnson & Johnson unit’s allegedly defective pelvic mesh products kicked off in Pennsylvania state court Friday as a jury heard arguments that a pair of the devices had mangled a woman’s urethra and left her incontinent. -
Mesh Pain – What Works for You?
Aug 7, 2017 | Mesh Medical Device Newsdesk
A few readers have called in that they find relief from mesh pain through some unusual options. Many readers want to avoid opiate use which can lead to addiction and constipation. Please let us know what works for you? -
The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases
Aug 4, 2017 | Mesh Medical Device Newsdesk
She has spent over 15 years advocating for children and families, over twelve of them as a specialized care provider teaching coping and life skills. Wideman turned the skills on herself after what she calls a disastrous experience with pelvic mesh implant failure and rejection. -
Vaginal mesh surgery advice issued to GPs by NI health board
Aug 7, 2017 | BBC
By Marie-Louise Connolly
The Health and Social Care Board (HSCB) has written to GPs advising what action they should take if any of their patients experience problems after vaginal mesh surgery. -
The biggest NHS scandal you've never heard of only affects women, but men should be just as concerned
Aug 5, 2017 | Independent
By Harriet Marsden
Transvaginal mesh can lead to side effects ranging from chronic pain to organ damage and paralysis, yet the NHS still continues to recommend the procedure based on dubious data. This isn’t a women’s issue; it’s a national health concern -
'The day before my vaginal mesh surgery I ran 5k, now I wet myself and am in pain': Women reveal how their lives and marriages have been destroyed by contentious NHS implant
Aug 4, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
Two women have today revealed how their lives have been destroyed after having a controversial vaginal mesh implant fitted. -
'Vagina surgery ruined my life': Mum left unable to have sex with husband and struggles to use the toilet
Aug 5, 2017 | Mirror
By Tom Belger
A mother who had vaginal surgery for mild incontinence claims the procedure ruined her life - leaving her unable to do her job, have sex and in “constant pain”. -
The future use of vaginal mesh implants is set to be discussed by group of Welsh clinicians
Aug 4, 2017 | Wales Online
By Katie Sands
The Welsh Government is set to establish a small group of clinical leads and patient representatives so they can consider the latest recommendations and determine what further action it may need to take. -
NHS ‘Vaginal mesh implants cut people’s genitals’
Aug 5, 2017 | DeathRattleSports.com
By Caroline Morrison
Vaginal mesh implants are offered to women suffering from stress urinary incontinence or pelvic organ prolapse, yet more than 800 are suing the NHS and the implants’ manufacturers after suffering crippling pain that has left them unable to have sex or even walk. -
Surgical mesh: A decade of damage
Aug 7, 2017 | Newsroom
By Teuila Fuatai
The implanted mesh, made out of polypropylene, was supposed to strengthen weakened tissue and muscle areas, and alleviate their symptoms. However, between 2005 and 2008, those patients all suffered unexpected and severe complications from the surgery. -
Woman who lives in constant pain calls for op to be banned
Aug 4, 2017 | Bexhill Observer
A woman who lives her life in excruciating pain after a medical operation four years ago, joined other women at Parliament last month in a campaign to get the surgical procedure banned in the UK. -
Anguish of women who received vaginal mesh treatment
Aug 7, 2017 | The Glamorgan Gem
By Tim Chapman
A Barry woman has told The GEM of the anguish and pain suffered by some patients who have received vaginal mesh implants. -
Move to address concerns over vaginal mesh implants
Aug 7, 2017 | Derry Journal
The Department of Health has confirmed it is looking at addressing the “distressing side-effects” affecting some local women fitted with vaginal mesh implants.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Latest J&J Pelvic Mesh Injury Case Kicks Off In Philly
Aug 4, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (August 4, 2017, 7:13 PM EDT) -- The latest in a slew of cases over a Johnson & Johnson unit’s allegedly defective pelvic mesh products kicked off in Pennsylvania state court Friday as a jury heard arguments that a pair of the devices had mangled a woman’s urethra and left her incontinent.
The trial, the sixth that Ethicon Inc. has faced in Philadelphia County over its allegedly defective mesh, stems from injuries suffered by a woman whose implant sawed its way into her urethra, requiring three surgeries in an attempt to cure the complications.
“These defective products have literally mangled Ella Ebaugh’s urethra,” said Kline & Specter PC attorney Kila Baldwin. “She’s going to suffer with this for the rest of her life.”
Ethicon comes into the latest mesh-related case with a losing record after four out of five juries in prior trials in Philadelphia have sided with plaintiffs and returned a total of nearly $50 million in damages.
Baldwin said that Ebaugh was implanted with a so-called TVT-Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second implant later in the summer after her condition did not improve.
After reporting to her doctor in 2011 that she was having sudden urges to urinate and significant pelvic pain, it was discovered that the mesh had eroded into her urethra.
A series of surgical interventions followed that included one operation in which Baldwin said that Ebaugh was cut open from “hip to hip” in an effort to remove as much of the mesh as possible. Nonetheless, Baldwin said that scarring from the mesh implants had left Ebaugh’s urethra essentially propped open, making it all but impossible to control the flow of urine from her body.
Baldwin said that Ethicon was aware of complications with its mesh products but had not done enough to warn the medical community.
W. Curt Webb, an attorney with Beck Redden LLP representing Ethicon, countered that the risks related with mesh implants, including the risk of erosions like those suffered by Ebaugh, were well known to doctors.
He pointed to medical records showing that the doctor who performed Ebaugh’s implantations had discussed the risk of erosion with her, and that she had given her informed consent.
“Just because Mrs. Ebaugh’s TVT-Secur didn’t work doesn’t necessarily mean that it was defective,” he said. “We’re sorry for the fact that Mrs. Ebaugh had a bad result, but it’s a risk that she knew about and it’s a risk that the doctors knew about.”
Ebaugh is represented by Kila Baldwin of Kline & Specter PC.
Ethicon is represented by W. Curt Webb of Beck Redden LLP.
The case is Ella Ebaugh et al. v. Ethicon Inc. et al., case number 130700866, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Alyssa Miller.https://www.law360.com/articles/951617/latest-j-j-pelvic-mesh-injury-case-kicks-off-in-philly
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Mesh Pain – What Works for You?
Aug 7, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 4, 2017 ~ A few readers have called in that they find relief from mesh pain through some unusual options. Many readers want to avoid opiate use which can lead to addiction and constipation. Please let us know what works for you?
JACKIE
Jackie Bensinger, an acupuncturist from San Diego, here, says with one acupuncture treatment, her client with hernia mesh lost the feelings of discomfort. Bensinger thought it would take at least six sessions.
DORIS
Doris says her doctor prescribed suppositories so she could resume going to the gym and walking even though she is fighting mesh pain.
Dr. Hibner prescribes an opiate Ketamine, Diazapam and Baclaofen for pain. She gets it from a compounding pharmacy and save the exorbitant retail cost. The medication comes in the form of a suppository.
She says it gives her “freedom to exercise even though she still has pain.” And it doesn’t make her sleepy like other drugs. Here is an online discussion as a treatment for interstitial cystitis or painful bladder syndrome, as well as here.
BETHA Florida woman used a comfrey plant she makes into an oil with coconut oil and beeswax, which she uses externally and calls a “miracle.”
Also the herb, Malva Sylvestris is boiled down and drained it with a cheesecloth. Learn more here.
You may want to consult with an herbalist before you embark on your own path with herbs!!
See www.wisewomanweb.com and there is more here on comfrey leaves, which should also be used externally.
Understanding, all of this may not be your cup of tea. ###
https://www.meshmedicaldevicenewsdesk.com/mesh-pain-works/
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The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases
Aug 4, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 21, 2017 ~ Canadian, Nonie Wideman, is a survivor of medical complications from synthetic medical mesh.
She has spent over 15 years advocating for children and families, over twelve of them as a specialized care provider teaching coping and life skills. Wideman turned the skills on herself after what she calls a disastrous experience with pelvic mesh implant failure and rejection.
Wideman says, “I had to recognize the problem, set goals to address the problem, and evaluate the effectiveness of my plan to deal with the problem.”“I began relentlessly researching the “what the hell went wrong?
“It appears the “what the hell went wrong” question was largely ignored, unrecognized, and minimized in the medical community and buried by manufacturers of synthetic medical mesh whom I feel definitely patted themselves on the back, for their part in improving quality of life for people having issues with prolapses, hernias and incontinence.
“Research revealed a lack of long term studies regarding the safety and reliability of medical mesh implants, the lack of follow up with patients receiving the aforementioned mesh products, lack of understanding by the medical community that they had regarding the rates of failure, the cause of failure, and the consequences of prolonged and chronic exposure.
“I wish to challenge all my readers to question the use of synthetic medical mesh and ask for accountability from those who profited from the sale of these products at the expense of a significant number of patients living in the aftermath of synthetic medical mesh degradation and implant failure. With knowledge and truth we can join together to advocate for safety before profit. I hope to empower people to demand honest answers and demand change.”
by Nonie Wideman, April 2013
BackgroundWhen researching mesh complications, if one were to listen to the most knowledgeable experienced people on the subject, one would not be listening to doctors or mesh manufacturers. To know exactly what is going on it would seem prudent to first talk to, and listen carefully to, the women implanted with polypropylene meshes for prolapse (POP), stress urinary incontinence (SUI) and listening to men and women with mesh hernia repairs. In defense of their own health, to advocate for skilled medical intervention to reduce pain and gain back quality of life, they have had to research to find answers as to why they hurt, why doctors think their pain is anything but mesh related, why they are sick, why their complications are hard to diagnose, and why doctors are reluctant to diagnose what is obvious to women and men with computers, internet and Google skills.
It is sad when patients have done more research than doctors.
Listening to the women with first-hand knowledge of transvaginal mesh complications, one thing is being made very clear by women; not enough attention is being paid to the systemic injury of mesh complications. When listening to hernia patients, men and women are saying mesh complications affect your whole body, not just your abdomen. According to Jonathan Blac (1984):
“Evaluation of the host response to implanted biomaterials usually focuses on the implant site tissue response. This may lead to erroneous conclusions in the same way that examination of battles outside of their historic context does. A broader view discloses a variety of possible and actual systemic effects of carcinogenic, metabolic, immunological and bacteriological nature. Recognition of these effects in patients is hampered by a lack of epidemiological studies (19).”
Researching patients found they were not alone with their questions or symptoms. Patients like me discovered they could be considered by the medical community as high responders to medical mesh. In other words, we are all the population of patients experiencing chronic foreign body reaction to synthetic mesh implants. These synthetic meshes mentioned are predominately constructed of polypropylene or similar polymeric constructs. To break it down in simpler terms we all found that hypersensitivity to foreign body implants was, and is, the common denominator among us. You might say for simplicity‘s sake we high responders are all “allergic” to the materials doctors implanted in us.Foreign Body Response
With the recent trials over the injuries caused by the controversial transvaginal implants, it becomes very evident that research into the long-term effects of polypropylene in human bodies is, as I have discovered, is almost non –existent. I say “almost “, because there may be some study somewhere I have missed or others have missed that would enlighten us all. Alas, I have not found long-term studies that show what to expect with controversial synthetic meshes 3, 5, or 10 years into the future. Personal experience and research however indicates that complications may present with mesh implants as long as the implant remains in a live body.
With the new emerging information from the FDA that indicates complications rates to be higher than predicted or thought acceptable, for benefit to risk ratios, it appears more scrutiny is needed, and was needed. Scrutiny comes late, and comes at the expense of patients’ health (5).
When synthetic mesh is surgically placed in your body, if your body is over sensitive, it matters not how skilled the surgeon is or unskilled he is at placing mesh, when it is the properties of the mesh and the body’s ensuing expected foreign body response gone awry that causes oxidative processes in the body to try degrade the foreign body enough so that cells can “eat” or dispose of the foreign matter that it can’t push out like a puss surrounded splinter. That oxidative process of chronic foreign body response has been proven to degrade polypropylene (7).
Polypropylene mesh does not remain inert when constantly attacked by the oxidative processes of Foreign Body Response (12).( Should mesh actually ever have been considered inert in the first place as it is recognized by the human body as a foreign body as soon as it is implanted? )
Degradation products of polypropylene are Alkyl radical, Alkoxy radical ,Peroxy radical and Hydroperoxide (1). Note that these degradation products are free radicals, and they are considered toxic. If polypropylene has been treated with other surfactants to help dye fixation, as in blue dyed medical mesh, or treated with chemicals for sterilization because heat sterilization damages the mesh, then there are other degradation products to worry about.
Polymeric materials have long been identified as leaching estrogenic mimicking chemicals that are known to make cancer cells multiply; for example blue polypropylene piperettes used in lab experiments were found to be the source of experiment contamination in lab research. Women are wondering about nonylphenol leaching out of meshes and its estrogenic role in enabling cancer.
Scientists know polypropylene degrades under oxidative stress. Did no one think to test what chemicals could leach out and cause toxic chaos inside of peoples’ bodies? You would think because the implants were designed to be permanent, substantial testing would have occurred before marketing such medical devices. Substantial testing was not done (16).
Where am I going with this?Systemic Storm
I am listing the ingredients of a recipe for autoimmune disease to develop. It is a recipe for a systemic storm. It is a storm that also can predisposes one to cancer. Predisposition for higher rates of cancer after mesh complications, is a subject deserving of an article all of its own. This article’s purpose is to draw attention the fact that there appears to be a high rate of autoimmune disorders in the population of women with chronic FBR that has caused implant failure and degradation.
I took a survey of patients with medical mesh complications that validated my suspicions and the suspicions of other patients. Many thanks go out to those who took the survey in order to get a real snapshot of what the unrecognized systemic diseases are that mesh complication patients are dealing with, seeking validation for, and seeking skilled medical intervention for. I will share survey information at the conclusion of this article.#1 Ignorance: No Biocompatibility Tests
I draw your attention back to the recipe for a devastating storm. The number one ingredient in this systemic storm is ignorance. Doctors appear to have no tests to predict hypersensitivity to polypropylene in candidates for synthetic mesh implants. Hypersensitivity (which may be a genetic predisposition or an acquired condition) should be a contraindication for a patient to be implanted with a synthetic material known to cause an inflammatory response, just as having an underlying autoimmune disease is a contraindication for mesh implantation according to some mesh manufacturer’s instructions for physicians (13). That contraindication warning for surgeons makes me wonder what manufacturers really knew about the connection between FBR and autoimmunity and implant failure or success and failed to share with physicians and surgeons.#2 Foreign Body Response
The second ingredient for a harmful systemic storm is a combination of the short term acute inflammation of FBR that usually decreases after thirty days from when the mesh is implanted, preceded by decreasing low grade chronic inflammation thereafter. (2) However decreasing FBR is not always the outcome. Women with synthetic mesh implant complications have learned the hard way, that for women with mesh complications and implant failure, FBR does not decrease but increases, causing distressing cycles of burning sensation and pelvic cramping pain that many women say exceeds the pain of child birth and never ends. According to an article by a cancer treatment centre (3) “inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process.” Cancer researchers know there are links between chronic inflammation and cancer development (17, 18 ). Autoimmune researchers know there are links between autoimmune disease development and chronic inflammation (23 ). Some surgeons know there is a link between implants and autoimmune disease development (14).# 3 Chronic Infection
Now the 3rd ingredient is a hit and miss in this recipe . It is like an optional ingredient you would never want .That ingredient is chronic infection. Many patients with mesh complications have chronic infections, infections safely hidden in mesh structures too small for “good guy” cells to go in and attack bacterial infection.
Prof. Garth L. Nicolson states in his article Autoimmune Illnesses and Degenerative Diseases,“chronic infections play an important role in autoimmune and degenerative disease, along with genetic predisposition and immune dysfunction (22).” Nicolson also states infection could be the cause of autoimmune disease or a cofactor.
Reading the study, Localized Immunosuppressive Environment in the Foreign Body Response to Implanted Biomaterials by David M. Higgins,* Randall J. Basaraba,* April C. Hohnbaum,* Eric J. Lee,* David W. Grainger,† and Mercedes Gonzalez-Juarrero , you become more aware of the serious harm of chronic infection and implant failure. According to these researchers “It is estimated that at least 20 million people in the United States have a biomaterial device implant. Implant device failure or implant-associated infections can have disastrous consequences for the implant device function and the host. Although the risk of implant-associated infections is small (1 to 7%), these infections are associated with considerable morbidity, expensive health care, and prolonged antibiotic therapy.2 The medical and surgical cost of treating certain device failures or implant-associated infections can average up to $50,000 per patient.3,4 These significant burdens and the increasing use of biomaterial implants in a myriad of medical applications warrants a clear understanding of the immune response to these materials (15 ) .”
So now we have recognized the following ingredients for a health disaster.
#1) hypersensitivity undiagnosed
#2) chronic inflammation causing degradation of mesh
#3) chronic infection.
#4 Chemical Insults
Now let’s add the 4th ingredient to the systemic storm recipe. Let’s add chemical irritation and insult. One product of the body’s attempt to break down polypropylene via peroxide (hydrogen peroxide produced by the body) is the dangerous Hydroxyl radical. Life Extension Magazine published a report in 1995 on the Hydroxyl radical. It was stated “the uncontrolled action of hydroxyl radicals the most damaging free radical by far can have devastating effects with the body.”
Consequences of hydroxyl can be seen in many diseases such as atherosclerosis, cancer and neurological disorders (4). To add to the evidence that degradation of polypropylene releases damaging hydroxyls note the quote from S. A. M. Ali, P. J. Doherty, D. F. Williams*Article first published online: 10 MAR 2003.
“Degradation is an essential factor in polymer biocompatibility. The physiological environment of the human body can be aggressive to polymers. Most implanted polymers suffer degradation and the kinetics and mechanisms of the processes can be significantly affected by various biologically active species, especially enzymes, lipids, peroxides, free radicals, and phagocytic cells. Iron enhances the toxicity of oxygen free radicals. Superoxide and hydrogen peroxide can interact to form the very toxic hydroxyl radical in the presence of iron. The data have shown that the hydroxyl radical is likely to be one of the main causes of polymer degradation in implantable devices. “
I could go on and on about the damage of free radicals but the point again is once again about inflammation; inflammation increased by chemical irritation. Inflammation is heightened by the reaction of damaged tissues surrounding the implant, tissues subjected to the peroxide attack against the implant material. Inflammation, chronic inflammation, has long been recognized as being a cause of diabetes, a cause of heart disease and a symptom of autoimmune disease. Perhaps more research should be done to address the fact that inflammation may not only be a symptom of autoimmune diseases but in fact be the cause of an autoimmune disease.
Lupus is one of the very scary autoimmune diseases some women are being diagnosed with after mesh implantation, after suffering months if not years of chronic pelvic inflammation from FBR to synthetic mesh. Many other autoimmune diseases are being diagnosed and suspected in this cohort of women, and in the population of hernia patents experiencing chronic FBR. Read the following abstract regarding Lupus by Zafar Rasheed, , Rizwan Ahmad, Naila Rasheed and Rashid Ali (2007)
“Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with autoantibodies as a near universal feature of the disease. Earlier investigations from our laboratory revealed increased oxidative damage in SLE patients. Therefore, we hypothesized that oxidative by-products, such as hydroxyl radical (√OH), could lead to neoantigens like √OH damaged human serum albumin (HSA), which could in turn initiate autoimmunity in SLE (21).”
So back to the recipe,
So now we have,
#1) hypersensitivity undiagnosed
#2) chronic inflammation causing degradation of mesh
#3) chronic infections from mesh porosity size allowing bacteria a safe haven
#4) chemical insults, the degradation products of the oxidative process caused by FBR which are free radicals, the most worrisome being hydroxyl
#5 Oxidative Stress and Damage
The recipe for a systemic storm is not complete yet.
Consider a statement by Kurien BT, Hensley K, Bachmann M, Scofield RH. 2006 May 23.
“Free radical-mediated oxidative damage and consequent protein modification by the end products of oxidative damage are important mediators of cell toxicity and disease pathogenesis”.
(Free Radic Biol Med. 2006 Aug 15;41(4):549-56. Epub 2006 May 23. Oxidatively modified autoantigens in autoimmune diseases.)
http://www.ncbi.nlm.nih.gov/pubmed/16863987?dopt=Abstract&holding=f1000,f1000m,isrctn)
We can now add oxidative damage or stress to the growing list of recipe ingredients for a damaging systemic storm. According to many research articles oxidative stress is implicated in autoimmunity onset, progression and exacerbation. (8, 9, 10,11 ).
For example, in the paper by MR Namazi, (http://www.jautoimdis.com/content/6/1/4Cytochrome-P450 enzymes and autoimmunity: expansion of the relationship and introduction of free radicals as the link …..) we can read about the link between chronic oxidative stress and the evolution or trigger of autoimmune disease.
“ Hydroxyl radicals are also very highly reactive and could attack a wide range of targets. The presence of rheumatoid factors in some autoimmune diseases, such as vitiligo [9,11] and rheumatoid arthritis, can be explained by this mechanism. Over time, chronic oxidative stress could generate several adducted and/or non-adducted molecules that would essentially act as a “neo-antigens”. This is consistent with the slow maturation of auto-antibodies in the evolution of autoimmune diseases. During chronic oxidative stress, neo-antigens potentially cause tissue damage and release a plethora of sequestered auto-antigens. This process is referred to as the “bystander effect”. Such an outburst of auto-antigens from the target tissue would potentially amplify the effect of the neo-antigens, leading to the breakdown of self-tolerance [8].”
Furthermore , according to Dr. Ray D. Strand, MD,
“There has been great interest among researchers for the past 20 years involving the role of oxidative stress in the development of arthritis. Most studies have not separated rheumatoid arthritis and osteoarthritis (degenerative arthritis) when looking at free radical reactions and these diseases. Information provided here is consistent with a comprehensive review article written by Dr. Henrotin in 1992 regarding oxidative stress and how it is involved in inflammatory joint disease. Several recent studies have further established oxidative stress as being the plausible cause of these diseases.”
“The immune system is intended to be our reliable protector. It is always checking for self (one’s own body) while it is looking for non-self (any foreign substance or abnormal cell). When the immune system finds a virus, bacteria, or foreign body it destroys and eliminates it from the body. However, in autoimmune diseases the immune system actually attacks itself rather than a foreign substance. If it attacks the joint space, a person is diagnosed as having rheumatoid arthritis. If it attacks the bowels, it manifests as Crohn’s disease or ulcerative colitis. When the connective tissue is attacked, a person might end up with scleraderma or lupus. If the myelin sheath around the nerve is the target, multiple sclerosis (MS) ensues. (www.raystrand.com/recommendations )”
Transobturator surgery
Note the statement that recent studies established oxidative stress as being the plausible cause of autoimmune diseases. Now who in their right mind would argue that mesh complication patients don’t have oxidative stress when enduring chronic painful FBR? So I will add oxidative stress to the recipe.
So now we have,
#1) hypersensitivity undiagnosed
#2) chronic inflammation causing degradation of mesh
#3) chronic infections from mesh porosity size allowing bacteria a safe haven
#4) chemical insults,degradation products of the oxidative process caused by FBR which are free radicals, the most worrisome being hydroxyl
#5) oxidative stress
When you look at that recipe and realize that chronic FBR goes undetected for long periods of time (sometimes years) in mesh complication patients, you may wonder why is it going undetected for so long? It appears that doctors are not looking for FBR symptoms! They don’t see what they do not recognize! Chronic FBR causes mesh degradation, causes systemic chain reactions, and causes autoimmune vulnerability. When delays in diagnosing mesh complications initiated by FBR happen, when misdiagnosing mesh complications as irritable bladder happen, it is like planting an autoimmune disease seed in a hot bed and then wondering why it grew so quickly and strong! The recipe ingredients outlined are all in mesh complication patients! Why are so many doctors seemingly oblivious to the obvious? My answer would be liability and accountability. The links are all there if one chooses to seek them…, one reaction sets off a chain reaction. So no surprise is among mesh victims sharing info about autoimmune issues after FBR to synthetic mesh. There is sadness, anger, and grief as many mesh complication victims not only learn to live with chronic pain but irreversible autoimmune diseases as well.
I believe future studies will prove that autoimmune diseases, are being diagnosed at higher rates in the population of women who have experienced extreme chronic FBR to synthetic mesh than those of the population with no synthetic implants or no known FBR to implants that have not degraded or caused adverse events. I believe this statement would hold true for our male counterparts with hernia mesh complications. Research needs to be focused on the systemic effects of FBR induced mesh complications.
Doctors, especially primary care givers need to be educated to know the signs of FBR in their mesh implanted patients, and understand the progression from FBR to implant failure to autoimmune disease. Mesh complications are complicated!
It is not just about pain, erosion, extrusion, infection, organ perforation, the inability to sit, to have sexual relationships. It really is about quality of life issues that are not reversible, that are a whole body injury from a less than perfect implant material. Systemic effects from mesh can kill slowly or quickly.
Make no mistake, mesh can kill. Call it slow death by mesh if no doctor can remove your mesh implant or is willing to try when you are one of the not so rare patients experiencing chronic FBR, and in the eye of the perfect storm for a disaster. Am I being dramatic? Some doctors might think so. Patients with mesh complications would say no, no drama; it just is the way it is.
My survey of a group of patients with medical mesh complications results show that post implant surgery;
12% developed diabetes, or been diagnosed as pre-diabetic.
51% experienced Weight loss
3% developed asthma
20% reported exacerbation of pre-existing asthma
3% diagnosed with Lupus
12% developed rheumatoid arthritis
10% reported exacerbation of pre-existing arthritis
100% noticed a marked lack of energy post implantation, chronic fatigue
14% diagnosed with chronic fatigue syndrome
71 % have undiagnosed chronic fatigue symptoms
24% diagnosed with fibromyalgia
41% reported symptoms of fibromyalgia to be addressed or being addressed
63% reported blurred vision post mesh implant
44% reported having elevated fever, higher body temperature
39% reported lower body temperature
44% reported Hair loss, loss of facial and scalp hair
17% reported Hyperpigmentation, or dark tanning in skin
29% reported Painful skin rash,
25% reported Fragile thin skin
36% reported Skin that bruises easily
24% reported acne
24% reported Skin rashes, especially “butterfly rash” on the nose and cheeks
41% reported Sun sensitivity
46% reported dry eyes
44% reported dry mouth
51% reported extreme sensitivity to cold in the hands and feet
76% reported Recurring abdominal bloating and pain
39% High blood pressure
90% Irritability, anxiety and depression
92% reported “Brain Fog,” difficulty concentrating,
53% reported Lack of coordination or unsteady gait
61% reported Dizziness, vertigo
58% reported Numbness, weakness, tingling or paralysis in one or more limbs
27% Tremors
25% Cysts on Ovaries
41% Increase in snoring
63% Shortness of breath and tightness in the chest
22% Unexplained anemia (low count of red blood cells
8% diagnosed with a connective tissue disorder post mesh
2% have you been diagnosed with cancer post mesh implantation
32% reported chemical sensitivities started post mesh implantation
41 % reported food sensitivities started post mesh
What could these symptoms indicate ?
What are these symptoms associated with? You guessed it ….autoimmune diseases! Clearly we need research and scrutiny into the progression from foreign body response from synthetic mesh to autoimmune diseases development. Clearly if one researches one can see the dots connect! I suspect those who have the most to lose will not look, research or admit to causing autoimmune problems by using non-inert mesh in highly susceptible patients. And here is a big question … if mesh becomes non-inert in 33% of the people it is implanted into, is the mesh defective?
Clearly, mesh degrades. Is that not a defect? It is designed to be permanently implanted so one would not find it a stable product if 33% of the meshes implanted degrade and the implants fail. This is a Pandora’s box. Who is brave enough to take on the manufacturers ? Is the ultimate liability so scary the judicial system will avoid finding the product defective but give higher punitive awards for failure to warn?
Well, that question is food for more thought, to add to what I have already tried to piece together for a clearer picture of why implant rejection and failure is more than just a localized wound, but the starting point for a host of autoimmune systemic problems going unrecognized, unresearched, and untreated.
LEARN MORE:
References
1) http://www.pqri.org/workshops/leach_ext/imagespdfs/posters/Polymer_Additives_PQRI_Poster.pdf
2) Long-term foreign-body reaction to preperitoneal polypropylene mesh in the pig, G. L. Beets, H. van Mameren, P. M. N. Y. H. Go
http://link.springer.com/article/10.1007/BF01569134
3)http://www.envita.com/cancer/chronic-inflammation-fuels-development-of-stage-cancer/
4) Oxidative Medicine and Cellular Longevity Volume 2011 (2011), Article ID 809696, 9 pages doi:10.1155/2011/809696 Review Article Hydroxyl Radical and Its Scavengers in Health and Disease,Boguslaw Lipinski, Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215, USA Received 30 March 2011; Accepted 7 June 2011 Academic Editor: Kennet Maiese http://www.hindawi.com/journals/oximed/2011/809696/
5) Systemic effects of biomaterials Biomaterials ,Volume 5, Issue 1, January 1984,Pages http://www.sciencedirect.com/science/article/pii/0142961284900619
Jonathan Blac
University of Pennsylvania, Philadelphia, Pennsylvania, USA
http://dx.doi.org/10.1016/0142-9612(84)90061-9, How to Cite or Link Using
Abstract: Evaluation of the host response to implanted biomaterials usually focuses on the implant site tissue response. This may lead to erroneous conclusions in the same way that examination of battles outside of their historic context does. A broader view discloses a variety of possible and actual systemic effects of carcinogenic, metabolic, immunological and bacteriological nature. Recognition of these effects in patients is hampered by a lack of epidemiological studies.
Keywords
6) Autoimmunity. 2007 Nov;40(7):512-20.
Enhanced recognition of reactive oxygen species damaged human serum albumin by circulating systemic lupus erythematosus autoantibodies.
Sheikh Z, Ahmad R, Sheikh N, Ali R.,Source Department of Biochemistry, Faculty of Medicine, AMU, Aligarh, India. zrasheed@rediffmail.com http://www.ncbi.nlm.nih.gov/pubmed/17966041
7) The mechanisms of oxidative degradation of biomedical polymers by free radicals
http://onlinelibrary.wiley.com/doi/10.1002/app.1994.070510805/abstract
S. A. M. Ali, P. J. Doherty, D. F. Williams*
Article first published online: 10 MAR 2003
DOI: 10.1002/app.1994.070510805
Abstract
Degradation is an essential factor in polymer biocompatibility. The physiological environment of the human body can be aggressive to polymers. Most implanted polymers suffer degradation and the kinetics and mechanisms of the processes can be significantly affected by various biologically active species, especially enzymes, lipids, peroxides, free radicals, and phagocytic cells. Iron enhances the toxicity of oxygen free radicals. Superoxide and hydrogen peroxide can interact to form the very toxic hydroxyl radical in the presence of iron. The data have shown that the hydroxyl radical is likely to be one of the main causes of polymer degradation in implantable devices. © 1994 John Wiley & Sons, Inc.
8) http://europepmc.org/abstract/MED/12799017
“Increasing evidence shows that oxidative stress plays an important role in the pathogenesis of multiple sclerosis (MS) and its animal model, experimental autoimmune encephalomyelitis (EAE).”
9) http://www.ncbi.nlm.nih.gov/pubmed/22291449
Oxidative stress promotes hypertension and albuminuria during the autoimmune disease systemic lupus erythematosus.
10) Source http://www.ncbi.nlm.nih.gov/pubmed/22291449
Mathis KW, Venegas-Pont M, Masterson CW, Stewart NJ, Wasson KL, Ryan MJ.Department of Physiology and Biophysics, University of Mississippi Medical Center, Jackson, MS 39216-4505, USA.
Abstract: Several lines of evidence suggest that essential hypertension originates from an autoimmune-mediated mechanism. One consequence of chronic immune activation is the generation of oxygen-derived free radicals, resulting in oxidative stress.
11) http://www.ncbi.nlm.nih.gov/pubmed/16863987?dopt=Abstract&holding=f1000,f1000m,isrctn
Kurien BT, Hensley K, Bachmann M, Scofield RH.
Source :Free Radic Biol Med. 2006 Aug 15;41(4):549-56. Epub 2006 May 23.
Oxidatively modified autoantigens in autoimmune diseases. Arthritis and Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, OK 73104, USA.
AbstractFree radical-mediated oxidative damage and consequent protein modification by the end products of oxidative damage are important mediators of cell toxicity and disease pathogenesis. Aldehydic products, mainly the 4-hydroxy-2-alkenals, form adducts with proteins and make them highly immunogenic. Oxidative modification of proteins has been shown to elicit antibodies in a variety of diseases including systemic lupus erythematosus (SLE), alcoholic liver disease, diabetes mellitus (DM), and rheumatoid arthritis (RA). Oxidatively modified DNA (8-oxodeoxyguanine) and low-density lipoproteins (LDL) occur in SLE, a disease in which premature atherosclerosis is a serious problem
12)http://journals.lww.com/greenjournal/Abstract/2010/10000/Polypropylene_Vaginal_Mesh_Grafts_in_Gynecology.24.aspx Polypropylene Vaginal Mesh Grafts in Gynecology,Ostergard, Donald R. MD,Obstetrics & Gynecology:
October 2010 – Volume 116 – Issue 4 – pp 962-966
“ Noninert polypropylene degrades into potentially toxic compounds that would be expected to stimulate a greater inflammatory reaction leading to erosion……….Manufacturers need encouragement to develop meshes that are inert and incorporate without contraction along with routine clinical tests to detect “high responders” to avoid complications. Polypropylene is not inert within the human body.”
13) http://www.lifebeatonline.com/procedure/ProcedureLanding.bsci/,,/navRelId/1000.1002/method/Procedure/id/10001031/attributeTypeId/1/resourceTypeId/91/seo.serve CONTRAINDICATIONS….Autoimmune connective tissue disease……
14) http://www.ehcd.com/Implant_Syndrome_070711.pdf
IMPLANT SYNDROME ,William J. Rea, M.D., F.A.C.S., F.A.A.E.M.
“The surgical use of artificial implants can induce both autoimmune disease and chemical sensitivity.”
15) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2708803/)
16) http://link.springer.com/article/10.1007%2Fs00192-012-1678-2?LI=true
A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery
Mark Slack, Donald Ostergard, Mauro Cervigni, Jan Deprest,International Urogynecology Journal,April 2012, Volume 23, Issue 1 Supplement, pp 15-26
Abstract: Over the past decade, a huge number of new implants and ancillary devices have been introduced to the market. Most of these have become clinically available with little or no clinical data or research. This is a less-than-ideal situation, and this subgroup of the ad hoc IUGA roundtable conference wants to open the discussion to change this, by proposing a pragmatic minimum clearance track for new products being introduced to the market. It consists of an accurate and more standardized product description, data on the biological properties gathered in animal experiments, anatomical cadaveric studies, and upfront clinical studies followed by a compulsory registry on the first 1,000 patients implanted. Ideally, manufacturers should support well-designed prospective (randomized) clinical trials that can support the claimed benefits of the new product. Data were presented at the 2nd IUGA Grafts Roundtable June 2010.
17) http://clinicaltrials.gov/ct2/show/NCT01428167?term=chronic+inflammation&rank=85 Hashimotos Thyroiditis and Thyroid Cancer
Sponsor:The University of Texas, Galveston Information provided by (Responsible Party):The University of Texas, Galveston ,ClinicalTrials.gov Identifier:NCT01428167,First received: August 10, 2011 Last updated: June 5,
Thyroid cancer (TC) is the most common endocrine malignancy. The association between inflammation and cancer is well established.
18) http://www.envita.com/cancer/chronic-inflammation-fuels-development-of-stage-cancer/
Inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process. When these inflammatory responses become chronic, cell mutation and proliferation can result and often create an environment that is conducive to the development of cancer.
Inflammation is the body’s response to tissue damage, caused by physical injury, ischemic injury (caused by an insufficient supply of blood to an organ), infection, exposure to toxins, or other types of trauma. The body’s inflammatory response causes cellular changes and immune responses that result in repair of the damaged tissue and cellular proliferation at the site of the injured tissue. Inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process. When these inflammatory responses become chronic, cell mutation and proliferation can result and often create an environment that is conducive to the development of cancer. This is often referred to as “the perfect storm.”
19) http://www.sciencedirect.com/science/article/pii/0142961284900619
Jonathan Blac, Systemic effects of biomaterials, Biomaterials Volume 5, Issue 1, January 1984, Pages 11–18Biointeractions ’84 Materials/Interactions-Conference Systemic effects of biomaterialsUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA
20) http://onlinelibrary.wiley.com/doi/10.1002/app.1994.070510805/abstract
The mechanisms of oxidative degradation of biomedical polymers by free radicals ,S. A. M. Ali, P. J. Doherty, D. F. Williams*,Article first published online: 10 MAR 2003 ,DOI: 10.1002/app.1994.070510805
21) http://informahealthcare.com/doi/abs/10.1080/08916930701574331
2007, Vol. 40, No. 7 , Pages 512-520 (doi:10.1080/08916930701574331)
HTML PDF (213 KB) PDF Plus (217 KB) Department of Biochemistry, Faculty of Medicine, AMU, Aligarh, 202002, IndiaDepartment of Biochemistry, SBSPGI, Balawala, Dehradun, 248161, IndiaDivision of Pharmacology, Central Drug Research Institute, P.B. No. 173, Lucknow, Indi
22) (http://www.immed.org/illness/autoimmune_illness_research.html
23) http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2249.2003.02104.x/full
H Ahsan, A Ali, R Ali – Clinical & Experimental Immunology, 2003 – Wiley Online
Summary: Reactive oxygen species generated during various metabolic and biochemical reactions have multifarious effects that include oxidative damage to DNA leading to various human degenerative and autoimmune diseases. #
https://www.meshmedicaldevicenewsdesk.com/the-links-between-surgical-mesh-complications-and-the-development-of-autoimmune-diseases/
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Vaginal mesh surgery advice issued to GPs by NI health board
Aug 7, 2017 | BBC
By Marie-Louise Connolly
The Health and Social Care Board (HSCB) has written to GPs advising what action they should take if any of their patients experience problems after vaginal mesh surgery.
The move comes after the BBC revealed that a number of women felt physically and mentally scarred after having the implants.
Mesh or tape implants are used to treat organ prolapse or urinary incontinence.
These conditions can be common after childbirth.Women launch legal action over implantsGynaecologist "astonished" NI women sought care in England
The board's letter, leaked to the BBC, advised GPs to refer the women back to the health trust that performed the surgery with a letter stating that the referral is "because of problems associated with mesh surgery".
The letter goes on to state that each trust should have arrangements in place for these women to be seen by a consultant.
A spokesperson for the local action group, which now has over 250 members, welcomed the move but told the BBC that it was sad that some women had to go public with their personal stories in order for some health professionals to take them seriously.
In July, a group of women from across the UK affected by vaginal mesh implants, including many from Northern Ireland, met with MPs at Westminster as part of a campaign to ban the procedure.
http://www.bbc.com/news/uk-northern-ireland-40833695
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Aug 5, 2017 | Independent
By Harriet Marsden
Transvaginal mesh can lead to side effects ranging from chronic pain to organ damage and paralysis, yet the NHS still continues to recommend the procedure based on dubious data. This isn’t a women’s issue; it’s a national health concern
This year, news broke of a dangerous medical device, after years of campaigning and investigation.
Senior doctors have said it could be the most serious medical scandal since thalidomide. There have been calls in Parliament for a public inquiry into the situation.
Oh and, you may not have heard of it – because it’s about vaginas.
Specifically, transvaginal mesh procedures, which many believe are unsafe, untested and improperly prescribed as a treatment for common complications related to childbirth, such as incontinence or prolapse. The scandal was the subject of The Independent’s long read last week, yet has has received relatively little headline attention.
This is partly, many sufferers believe, because of shame and stigma surrounding discussion of female genitals and sexuality, and partly because the disaster exclusively affects women.
Or does it?
To the men who wince when they read the word vagina and quickly turn the page, or who think “women’s health scandal” doesn’t apply to them, I say: this should concern you, because it affects you directly.
There have been accusations of whitewashing, cover-ups, corruption, financial conflicts of interest, poor regulation, lack of clinical trialling and insufficient data to properly represent risk and side effects.
There’s proof that the NHS is trying to minimise the scandal – minutes from a meeting in October obtained by the Press Association included a desire to “take the press element out of it” and “avoid media attention” on mesh.
Over 100,000 people are suing in America, where the device is classed as “high-risk” and the US Food and Drug Administration (FDA) issued a public health notification all the way back in 2008 insisting the device injured up to 40 per cent of women who had the procedure.
In 2014, the former Scottish Health Minister, Alex Neil, requested the NHS suspend the use of mesh in Scotland pending safety investigations.
And yet, the Medicines and Healthcare products Regulatory Agency (MHRA), our Government’s medical devices watchdog, continues to maintain that there is only a 1-2 per cent risk.
The final report, published in July, concluded that no update in safety regulation or policy was necessary, but it doesn’t factor in data on side effects which patients report to their GPs, rather than hospitals.
Nor does it feature any data on loss of sexual pleasure – it’s not classified as a “serious side-effect”, and it’s just not considered important. Many other long-term side effects go unreported, and are therefore not included in the report, nor taken into consideration by policy-makers.
If the MHRA and NHS England are basing safety recommendations on incomplete data sets (read: ignorance), then this has wider implications than just one procedure.
The device was approved for use in the EU before it was established as safe – via a device regulation loophole called “substantial equivalence”, which means it was considered similar enough to a device already on the market to be approved without any clinical trialling or long-term studies. But the device it was “equivalent” to had already been withdrawn from the market following serious concerns about long-term effects. Regardless, the mesh was approved.
If high-risk procedures and untested devices are still being given the all-clear, despite global litigation, health warnings and lack of proper trials, then that should worry all of us.
These devices are earning a truckload of money for the companies who marketed the mesh. There have also been accusations of conflicts of interests: that doctors and scientists involved in investigating the safety of the procedures were given research and travel grants from such corporations.
This “quick-fix” procedure has taken the place of more traditional, safer options like the autologous sling, and more effective non-surgical strategies for minor incontinence, like long-term pelvic physiotherapy.
How was this allowed to happen? The answer is highly complex, yet achingly familiar – and it isn’t just “vaginas”. It’s something that affects all of us: resources, or lack thereof.
Funding cuts, staff shortages, overcrowded and overstretched hospitals, time pressures on staff and on the NHS to keep beds free has led to a push towards quicker, short-term fixes that more doctors can be trained to perform, rather than more specialised operations.
Add this to a lack of proper data and a criminally weak medical device regulatory system that has seen the PIP implant and metal hip scandals in the last five years alone, and it becomes clear how we reached this point, especially when many of the side effects relate to gynaecological issues often dismissed by the medical community.
We should be concerned if our health system is forced to prioritise convenience and financial targets over wellbeing of its patients. The vaginal mesh is causing chronic burning pain, organ erosion, bladder and bowel perforation, tissue damage, and some women are even left wheelchair-bound.
These women’s sex lives are being ruined – and not just theirs. Some report that the mesh has sliced through the vaginal walls, cutting the man’s penis during sex. That ought to get everyone’s attention.
We must all fight against this, if not simply to end the suffering of women who could be our mothers, sisters, girlfriends or colleagues, then because the system which is still recommending the vaginal mesh, despite all these concerns, is a danger to all of us.
You may not have a vagina, but you do have a stake in this. Everybody does.
https://www.independent.co.uk/voices/trans-vaginal-mesh-scandal-thalidomide-tvt-gynaecology-vaginal-procedure-womens-health-feminism-a7878136.html
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Aug 4, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
· MailOnline backs campaigners who are fighting for the stopping of vaginal mesh
· Julie Gilsennan, who lives in Liverpool, was forced to give up being a paramedic
· The 41-year-old is now home-bound after having the 'gold-standard' treatment
· And biker Lizzy Ford will never be able to strap on her helmet and leathers again
· Ms Ford, 54, even blamed the breakdown of her marriage on the 'poison' mesh
Two women have today revealed how their lives have been destroyed after having a controversial vaginal mesh implant fitted.
Julie Gilsennan, 41, from Liverpool, went from running 5k before her surgery to now wetting herself - despite the procedure being designed to stop incontinence.
Lizzy Ford, 54, of Scottish Borders, who once relied on her motorbike will never be able to don her helmet and biker leathers again. She has also blamed the implant, which has left her in debilitating pain, on the breakdown of her marriage.
But these women are just the tip of the iceberg. Thousands more have been left suicidal, reliant on wheelchairs and unable to have sex again because of the 'gold-standard' NHS treatment.
The scandal came to light earlier this year, but its true extent is yet to be uncovered - though mounting pressure is being placed on health officials to address concerns.
Campaigners have helped gather momentum for a public inquiry into the implants, mostly through Sling The Mesh - run by former sufferer Kath Sansom, 49.
But she said the NHS is sweeping the topic under the carpet. However, her tireless campaigns have helped to raise a debate about the matter in Parliament. She has been supported by an MP leading calls for further investigations over the devices.
Labour's Owen Smith, who represents Pontypridd, said many women were promised the treatment would work, without being fully aware of the devastating risks.
It's 'unacceptable' that there is a two-year wait before the English and Welsh health watchdog releases its updated guidelines on mesh, he said.
Here MailOnline reveals the stories of Mrs Gilsenan and Ms Ford as we back the calls for a suspension to the controversial procedure.
'I had a mesh fitted for mild urinary incontinence and now I wet myself'
A mother-of-five who had a vaginal mesh implant fitted for mild stress incontinence now has to rush to the toilet and has even wet herself on several occasions as a result of the procedure.
Julie Gilsennan, 41, from Liverpool, had an implant fitted on February 1 as she would experience leaking if she coughed, sneezed or lifted something heavy, which was impractical given her job as a paramedic.
Although she can now sneeze without leaking, Ms Gilsennan has been left with an overactive bladder that makes her desperate for the toilet within 20 minutes of drinking.
Previously highly active, Ms Gilsennan even ran 5km the day before having the implant fitted, yet she now struggles to move as she suffers unbearable pain.
The agony has even forced her to quit her highly-challenging career as a paramedic in order to work from home alone.
Ms Gilsennan was told she would need up to six weeks off work after having the mesh fitted, however, she has been unable to return to work as a paramedic and instead works from home processing complaints to the ambulance service.
She said: 'I loved my job, I did it for 12 years. I miss being out on the road with colleagues and talking to people. Now I'm trapped inside my house.
'I'm in immense pain permanently. It's like a cheese wire, glass pain in my groin.
'I also have constant pain across my hips as if I have arthritis. I can't return to work as a paramedic.'
Ms Gilsennan is on a waiting list to have the implant removed and is hopeful it will occur next year.
Yet, it is unclear what complications she may suffer even after the mesh has been taken out.
Ms Gilsennan said: 'Once it's out I can hopefully return to work as a paramedic but I'm not sure.
'I can now cough without leaking but the mesh has given me an overactive bladder.
'Drinking a small bottle of water makes me desperate for the toilet within 20 minutes and I need to stay hydrated as a paramedic.
'I have wet myself on a number of occasions because I can't get to the toilet on time.
'I can live with some pain but I can't work as a paramedic if I have an overactive bladder.'
'The day before my surgery I ran 5k and now I struggle to walk'
Aside from her overactive bladder, Ms Gilsennan describes how the implant has had an impact on both her physical and mental health.
She said: 'The day before my surgery I ran 5km and now I struggle to walk.
'I also struggle to sit for a long time.
'I've gained over a stone in weight because I can't exercise and that's depressing.
'The mesh has also definitely affected my mental health, being in chronic pain is so draining.'
The procedure has also had an impact on her relationship, as Ms Gilsennan, who claims she was a patient person before the procedure, says coping with the pain has made her more irritable towards her husband.
The couple's sex life has also been affected, as Ms Gilsennan finds intercourse too painful.
'I feel really angry towards the NHS'
Ms Gilsennan went to her GP for advice and was offered no alternative aside from an implant, despite reports that physiotherapy cures such incontinence in up to 80 per cent of cases.
IT COULD BE AS BAD AS THALIDOMIDE
Senior doctors have already called for a public inquiry into the use of vaginal mesh surgery in Britain, saying it could be akin to the thalidomide scandal.
The scandal of the procedure, used to treat problems caused by childbirth, came to light earlier this year, has seen more than 800 women sue the NHS and device manufacturers.
But experts said the true number of victims could be much higher than officially reported and that hospital readmission rates for one form of mesh surgery is as high as 19 per cent.
A meeting held at the Houses of Parliament was organised by Labour MP for Pontypridd Owen Smith, along with campaign group Sling the Mesh, which wants to see the procedure banned entirely.
Speaking at the gathering in April, Carl Heneghan, professor of evidence-based medicine at the University of Oxford said: 'With thalidomide you could see the visual representation. [With mesh] you can't see it.
'We should have a public inquiry.'
Thalidomide was prescribed by doctors in the 1950s and 1960s as a treatment for morning sickness or insomnia - but it was withdrawn from sale in 1961 after babies were born with limb deformities and other damage.
Its UK manufacturer, Distillers Biochemicals, paid around £28million compensation following a legal battle by the families of those affected.
She said: 'My doctor didn't offer any alternatives. They just said the implant was wonderful, the best thing ever and "perfect for your and your lifestyle".
'They made no mention of the consequences.'
Ms Gilsennan believes the implant scandal has been deliberately covered up by the NHS.
She said: 'The truth about vaginal meshes has been swept under the carpet, they should have been withdrawn years ago.
'I feel really angry towards the NHS and Johnson & Johnson for manufacturing this.
'It's just not safe to have a piece of plastic inside you.'
Yet, despite her complications, Ms Gilsennan is thankful to have escaped the ordeal of other sufferers.
She said: 'I still consider myself lucky. Some women have had these cut through their vaginas and erode away their organs.'
The avid motorbike rider, 54, who will never be able to put her helmet on again
An avid motorbike rider will never be able to put her helmet on and sit on the saddle again - because of her vaginal mesh.
Lizzy Ford, 54, from the Scottish Borders, was fitted with the TVTO sling to combat her incontinence in June 2010.
But her body almost instantly succumbed to the horrendous pain, and she was left unable to walk without any help.
She now needs an electric wheelchair if she wants to go a far distance, and uses crutches if she needs to briefly use her legs.
Ms Ford, who is now in the process of a separation with her husband, even blamed the mesh on the breakdown of her marriage.
The only thing she was able to do each day was to drive down to the shops each day - but now her life is totally different following the removal of the mesh.
'I was on my death bed'
She told MailOnline: 'That's the day I was reborn because that's how it feels. My mobility is actually worse but I don't have the mesh itself.
'I feel well. I don't feel poisoned as I had been as I felt my immune system was shutting down. The mesh has had a huge part in the breakdown of my marriage.
'I felt like I was on my death bed this time last year. I was on so much pain relief, morphine, opiates, everything.
'My last seven years have been a living hell, a living nightmare.'
Ms Ford, who first learnt to ride her motorbike when she was 16, was very active before the accident that shattered her leg 18 years ago.
But the pain in her right calf never affected her mobility on the devastating scale that the controversial mesh did.
After undergoing two years of operations to fix her broken leg she was able to straight back onto her bike.
However, after having the procedure to fit TVTO seven years ago at Borders General Hospital, Melrose, she had to give up her bike for good.
'Gold-standard treatment'
Her surgeon suggested this 'gold-standard 20-minute' fix that would transform her life and combat her weak bladder.
Following the operation she instantly struggled to walk, describing her walk out of the hospital as one of the longest she's ever had.
Blood tests were conducted - but nothing came back. Ms Ford was then sent to a psychiatrist when she was told the pain was in her head.
Her now-retired consultant, who originally fitted her with the TVTO, even said she was the only one who had reported such problems.
She said: 'I had my mesh and I had a problem with my mobility, shooting pains down my leg, round my groin and in my hips.
'I kept going back to the doctor and at no point did he say it had anything to do with the mesh.'
When she realised it may be the mesh
Ms Ford's fortunes changed when she read something in her local paper two years ago about other women with similar symptoms who had been given the mesh.
After years of relentless campaigning to have her TVT removed, she was granted an investigation at Queen Elizabeth University Hospital, Glasgow.
A consultant immediately asked Ms Ford if she wanted it removed when she inserted a camera into her bladder to see what was going on.
To her relief, the TVT eventually came out on her birthday 12 weeks later on February 16 earlier this year - but she will never escape the side effects.
Other women should think carefully
She has since had advised all other women to think very carefully before they choose to have the procedure.
Ms Ford added: 'There are operations out there that are far more effective [than TVTO] - but they cost more. This is put into you for life.
'It was never designed to come out, it was designed to stay in.' She added surgeons have often described their attempts at taking out the mesh as trying to remove chewing gum from hair.
Ms Ford continued: 'It grates off, it splinters, it goes into the bowel, it goes into the bladder, it goes into the vaginal wall - it's outrageous.
'Things you think can't be connected to mesh, they are. It poisons you and breaks you down.'
Unable to work
The former Tesco worker was forced to give up her job because she was struggling to walk up and down the aisles while the mesh was fitted.
She then began working for a charity, organising events for the elderly in her local community - but the pain made her quit that, too.
Ms Ford decided to go to college to study, but she was forced to give that up too because of the mental side effects.
She told MailOnline: 'My world was taken away from me until eventually I had two hours a day on a Friday working on a till. That was my world.'
Ms Ford described the initial operation to put in the mesh as 'guesswork', as they surgeons 'go in blind' with no idea 'where they put it'.
Due to a lack of surgeons she is unable to have the remaining clamps removed as they are fixed in.
A spokesperson for Johnson & Johnson UK said: 'Implantable mesh devices, which are backed by years of clinical research, have undergone rigorous regulatory reviews and are considered to be the gold standard for the treatment of stress urinary incontinence by many doctors.
'Pelvic mesh devices have helped millions of women suffering from stress urinary incontinence and pelvic organ prolapse.'
Professor Keith Willett, medical director for Acute Care at NHS England, said: 'There’s no doubt there has been significant progress to improve information, care and support for women affected by SUI and POP.'
http://www.dailymail.co.uk/health/article-4756770/Sling-vaginal-mesh-MailOnline-launches-campaign.html
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Aug 5, 2017 | Mirror
By Tom Belger
Julie Gilsenan had to give up her job after getting a mesh implant to stop mild incontinence
A mother who had vaginal surgery for mild incontinence claims the procedure ruined her life - leaving her unable to do her job, have sex and in “constant pain”.
Julie Gilsenan, 41, said the operation in February meant she could no longer make love with her husband.
She is one of thousands of women calling for a ban on controversial vaginal mesh.
The material is inserted during surgery and many patients blame it for serious pain and other severe health problems.
An NHS England review last month said mesh remained a safe, effective option for incontinence or pelvic organ prolapse, and leading manufacturer Johnson & Johnson said most research, clinicians and patients backed their use.
But Mrs Gilsenan, from Netherton, Merseyside, and other patients claim the true number of women suffering complications could be higher than official figures suggest, the Liverpool Echo reports.
She had the operation for mild incontinence she has suffered since having her son seven years ago, but now regrets trusting doctors that it was the best option.
She said: “It really has ruined my life, it’s disgusting.
“I have constant pain in my hips, back and right down my legs, and a razor-sharp pain in my groin.
“I’m unable to return to my job, pass urine properly or have sex with my husband. That has a knock-on effect on your relationship.
“The day before my surgery I ran a 5k, and I used to run home at 7am after a 12-hour night shift as a paramedic.
“Now if I walk too far I’m in agony and feel like my legs might give way. I can’t drive for more than 20 minutes.
The mum-of-five added: “My son said ‘you can’t do fun things any more, can you’ - I can’t do active things like climbing up a hill or going on a bouncy castle with my kids.
“My employer has allowed me to work from home with a laptop, but we are vastly short of paramedics.
“I have to use a catheter to completely empty my bladder, and get constant urinary infections.”
She has become involved in the Sling the Mesh campaign group, which has lobbied Parliament and is backing legal action against Johnson & Johnson through lawyers Wedlake Bell.
A spokesman for the Liverpool Women's Hospital, where she had the operation, said: “Liverpool Women’s treats every patient individually and surgical procedures are only ever performed with the patient’s best interests in mind.
“The Urogynaecology multidisciplinary team oversees the care of all patients throughout their treatment. Women undergoing surgery for stress incontinence at Liverpool Women’s only do so following a full discussion with their clinicians and after receiving detailed information on the different treatment options available.
“Whilst we would not discuss an individual patient’s case in public, all women raising concerns about the outcome of their surgery are offered the opportunity to discuss the issues raised and potential resolutions are sought as part of their continued care.”
A Johnson & Johnson spokeswoman said: “We empathise with all women suffering from pelvic organ prolapse and stress-urinary incontinence, conditions that can be serious and debilitating, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so.
“Implantable mesh devices, backed by years of clinical research, have undergone rigorous regulatory reviews and are considered to be the gold standard for treating stress urinary incontinence by many doctors.
“We are confident [parent company] Ethicon has acted responsibly in the research, development and marketing of pelvic mesh products and we are prepared to defend these products.”
http://www.mirror.co.uk/news/uk-news/vagina-surgery-ruined-life-mum-10935001
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The future use of vaginal mesh implants is set to be discussed by group of Welsh clinicians
Aug 4, 2017 | Wales Online
By Katie Sands
A working group is set to be established to consider the latest recommendations about the use of vaginal mesh.
The Welsh Government is set to establish a small group of clinical leads and patient representatives so they can consider the latest recommendations and determine what further action it may need to take.
The working group will report to the Health Secretary Vaughan Gething .
Transvaginal mesh is one of several treatment options available for pelvic organ prolapse and stress urinary incontinence.
The Royal College of Obstetricians and Gynaecologists’ notes how evidence from the recently published UK PROSPECT study in The Lancet shows that mesh is a successful treatment for prolapse in most cases, and the majority of women treated with mesh respond well to the treatment.
But there is also a risk of possible complications which include mesh erosion, infection and bleeding, and the strain of future pregnancies may cause the prolapse to recur.
As part of the regular update programme, NICE is currently revising its guidelines on female urinary incontinence on pelvic organ prolapse and these are due to be published in 2019, the Royal College of Obstetricians and Gynaecologists’ (RCOG) website says.
Mr Eddie Morris, vice president for clinical quality at RCOG, said: “For many women suffering from these conditions, mesh devices can be an effective form of treatment which is less invasive than alternative surgical procedures.”
Sarah Thom, 49, from Neath , is just one of the women to have suffered complications.
In 2004, she had a hysterectomy and mesh implanted to correct a vaginal prolapse that occurred after giving birth to her second daughter.
It was two years later in 2006 that Sarah said she went to her GP, due to her suffering from recurrent bacterial infections.
Sarah says she saw a GP more than 20 times over the next eight years and claims she was referred to 11 consultants.
After it was discovered the mesh had eroded and partially rotted, a repair was carried out in 2014.
“I was told the mesh could have fused to my bladder, colon or other organ and a multi disciplinary team was put in place for the operation”, she said.
“When I came round the surgeon told me that he had been able to remove the rotten section and that the rest of the mesh remained intact”.
Sarah says the first time she realised mesh had caused problems to so many other people was after she saw a report from the Victoria Derbyshire programme on social media.
She wants to raise awareness of the dangers of mesh, and highlight the symptoms of complications so other women can be treated sooner.
A Welsh Government spokesperson said: “The procedure is one of a range of health care interventions available in Wales to help prevent urinary incontinence which can sometimes seriously influence the physical, psychological and social well being of affected individuals.
“Following concerns about the adverse events associated with the surgery raised in 2014, we issued advice and guidance to the NHS in Wales.
“This emphasised the need for informed consent, compliance with guidance and standards, and regular audits of surgery undertaken, adverse event reporting and ensuring that repeat surgery or removal of meshes is performed by properly qualified specialists.
“There have been very few adverse events reported in Wales. To maintain patient safety, we’ve reminded health boards to ensure they report any complications of surgery, and have given women who have had the procedure the option to self report problems or adverse effects.”
http://www.walesonline.co.uk/news/wales-news/future-use-vaginal-mesh-implants-13434834
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NHS ‘Vaginal mesh implants cut people’s genitals’
Aug 5, 2017 | DeathRattleSports.com
By Caroline Morrison
A mother has highlighted how an NHS ‘gold-standard’ treatment is ruining the lives of hundreds of women.
Vaginal mesh implants are offered to women suffering from stress urinary incontinence or pelvic organ prolapse, yet more than 800 are suing the NHS and the implants’ manufacturers after suffering crippling pain that has left them unable to have sex or even walk.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
After the tireless pursuits of campaigns, including ‘Sling the mesh’, to have the implants suspended, NICE is expected to announce updates to its mesh guidance in February 2019.
Speaking on BBC Radio 4’s flagship show Woman’s Hour, ‘Sling the mesh’ campaign leader KathSansom, who had the procedure back in 2007, spoke of how the 20-minute ‘solution’ to mild urine leaks has cut some women’s partners’ genitals during sex.
The programme also had a gynaecologist’s perspective, who argued it is often unclear whether the mesh itself is to blame for women’s pain, while adding that many women successfully have the implant without any complications.
Yet, Ms Sansom accused such doctors of having a conflict of interest, arguing they frequently receive research and travel grants when carrying out investigations on behalf of implant manufacturers.
‘Mesh cuts through women’s bowels and bladders’
Mother-of-two Ms Sansom , 49, had an implant fitted in March 2015 after suffering mild urine leakage while exercising following the birth of her daughter Daisy in 2002.
Doctors told her the procedure lasted only 20 minutes and was minimally invasive, with any pain disappearing after around two weeks.
Yet, when Ms Sansom , from Cambridgeshire, was continuing to battle crippling pain in her legs and genitals weeks after the procedure, an internet search told her she was one of many women all over the world suffering life-changing complications. She has since had her implant removed.
Ms Sansom said: ‘My story is minor compared to some. In some women the mesh has shrunk and sliced through their vaginal walls and they’ve not realised until its cut their partners during intercourse.
‘For some women its cut through their bowels or bladders. Women are in wheelchairs or need sticks to help them walk.’
Although supporters of the mesh argue there are numerous studies confirming the implant’s safety, Ms Sansom says these are highly flawed.
She said: ‘A lot of studies are very short term or are on animals who can’t speak of a loss of sex life or quality of life.’
Ms Sansom adds many trials only last up to around two years, yet some women who have had the procedure may not experience complications until nearly a decade later.
She said: ‘In one woman the mesh sliced through her urethra and she is in chronic pain eight years later; relying on painkillers and just sitting at home watching Netflix.’
Ms Sansom believes many doctors have a conflict of interest that spurs them to claim vaginal mesh implants are safe.
She told MailOnline: ‘A lot of surgeons are paid for research or given travel fellowships and are put up in a nice hotel if they research a certain type of mesh
‘They won’t turn around and say ‘they’re bad and we’re not happy about.’
Dr Mark Slack, consultant gynaecologist and urogynaecologist, who also appeared on Woman’s Hour, told MailOnline: ‘Conflicts of interest are declared in all publications when there has been funding by the manufacturer.
‘There is insufficient public funding to fund all of the research that needs to happen.
‘The articles that I have written have been written scientifically and objectively for which I received no payment.
‘All I have ever been paid for is a consultancy fee, which is a standard business arrangement.’
Dr Slack, who is based in Cambridge, argues there are good and bad mesh implant operations, with many women finding the procedure to be a solution to debilitating urinary incontinence or organ prolapse.
He said: ‘[When complications occur] it’s difficult to know if the mesh caused it or the incorrect technique to put it in.
‘There are many millions who had very effective solutions to a debilitating problem and are very happy with the outcome.
‘There are some operations that have very low complication rates and I’m scared we’ll throw the baby out with the bath water [if the mesh is suspended].’
Yet, Dr Slack and Ms Sansom both agree pelvic floor exercises can be a highly effective way of preventing and treating urinary stress incontinence, which women should try before considering having an implant fitted.
In response to claims the NHS deliberately ignored mesh implant complications, Professor Keith Willett, medical director for acute care at NHS England, said: ‘We are now providing more consistent information to women [with stress urinary incontinence (SUI) or pelvic organ prolapse (POP)]and their clinicians, better care and support in the way of 18 self-declared centres with the specialist experience and skills to assess women suffering from distressing complications and making improvements to data collection which will in turn lead to greater evidence on the safety and efficiency of devices.
‘I am reassured that this momentum will continue due to the commitment from NICE to update and develop further guidance related to the care of women with SUI and POP.
‘Our collective vision is that future patients recognise that they have been part of a shared decision-making process, understand the alternatives, benefits and risks, experience fewer complications and when complications do occur that they are treated promptly and effectively.’
http://www.deathrattlesports.com/nhs-vaginal-mesh-implants-cut-peoples-genitals/1290
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Surgical mesh: A decade of damage
Aug 7, 2017 | Newsroom
By Teuila Fuatai
It has been almost 10 years since NZ's Government was alerted to an issue with surgical mesh. Since then, hundreds have suffered injuries from high-risk surgeries. Authorities, including Health Minister Jonathan Coleman, have passed the buck continuously. Teuila Fuatai investigates.
Six years before Jonathan Coleman took up the health portfolio in 2014, 14 cases involving patients implanted with surgical mesh were flagged by ACC.
The implanted mesh, made out of polypropylene, was supposed to strengthen weakened tissue and muscle areas, and alleviate their symptoms. However, between 2005 and 2008, those patients all suffered unexpected and severe complications from the surgery.
Classed as "adverse events associated with the use of surgical mesh", the patient cases were referred by ACC to Medsafe - the Ministry of Health unit responsible for therapeutic product regulation.
Those 14 people - whose surgeries took place at both public and private hospitals around New Zealand - triggered the first Medsafe review into surgical mesh.
Importantly, they also laid the groundwork for what has become one of the country's worst-handled mass medical botch-ups.
To date, ACC has approved 800 injury claims related to surgical mesh, costing at least $12 million to the taxpayer.
A two-year Health Select Committee review into the use of the products - also used in hernia repairs - has proven ineffective, with hundreds of patient horror stories, and a hefty, nine-year paper trail involving numerous Government bodies, members of the medical fraternity and politicians, showing a lack of management and accountability for the "surgical mesh problem".
MESH DOWN UNDER
Patient advocate group Mesh Down Under (MDU), headed by Charlotte Korte, Carmel Berry and Patricia Sullivan, has grown to nearly 500 members since it was founded in 2012.
In that time, numerous petitions, communications and meetings with officials from ACC, Medsafe, the Ministry of Health, as well as the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), the Medical Council, the College of GPs, MPs and even Coleman himself, have taken place.
Most recently on July 28, Korte and Sullivan met with the Health Minister in Dunedin.
"We thought that we were finally making headway in getting that meeting, but it appeared he was relying on advisors who were obviously not giving him the full picture because he had no real idea of what the major concerns were," Korte said.
First, the pair was told Coleman would only have 15 minutes to meet.
During that time, only two concerns about surgical mesh were discussed - and even that was rushed.
"He wanted to leave after the first concern was raised," Sullivan said.
"His responses to our questions about the lack of progress in implementing Select Committee recommendations [were] completely unsatisfactory.
"He just told us that his advisors assured him they had been implemented, even when we pointed out they had not," Korte said.
"Looking back, it seemed like a PR exercise to show he was meeting with an advocacy group. His attitude towards us and ongoing problems with surgical mesh has been extremely tough to understand and endure - especially since he is a GP," Sullivan said.
"We see more New Zealanders being injured and have watched overseas authorities respond to the problem, yet the Health Minister seems apathetic in attitude and action."
COLEMAN'S RESPONSE:
When questioned by Newsroom, Coleman was adamant his handling of the use of surgical mesh in New Zealand had been satisfactory.
"What I've said to the people [Korte and Suillivan] I met with...because they raised a couple of issues [was to]...put them in writing."
"All the advice I've had is the [Health] Select Committee recommendations have been implemented, and that officials have followed up this issue in an appropriate way," Coleman said.
Seven recommendations were released by the committee in June last year at the conclusion of its review into the use of surgical mesh. Prompted by Berry and Korte's 2014 petition, a range of actions were recommended, including:
* The development of a national surgical mesh register
* Expansion of Medsafe's role so it can assess the quality and safety of a medical device prior to its approval for use in New Zealand
* A review of best practice around the informed consent process for surgical mesh procedures
* Formalising the requirement for the ongoing education of surgeons in the use of mesh, and its removal
* The use of a consistent coding system for surgical mesh by health practitioners, enabling the identification and monitoring of patients
Documents from Medsafe the Ministry of Health, ACC and RANZCOG, dating as far back as July 2007, show these organisations were well aware of serious gaps in New Zealand's approach to the use of surgical mesh.
Notifications from overseas bodies, including the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Authority, and equivalent authorities in the UK, Canada and Europe, warning of severe complications associated with surgical mesh over that 10-year-period, were all received by the Ministry of Health, Medsafe and RANZCOG.
Even more concerning, are the similarities between the cautionary advice outlined in those documents - reviewed by Newsroom as part of this investigation - and the recommendations released last year by the committee.
In one email dated May 22 2014 from Medsafe group manager Stewart Jessamine, two orders proposed by the FDA to address health risks associated with surgical mesh used in pelvic prolapse repair are discussed.
The email, sent to two senior MedSafe advisors and a senior media staffer, explained the FDA announcement but proposed no action regarding surgical mesh products in New Zealand.
At the time, the announcement prompted several manufacturers to pull mesh products from the US market because they could not show the FDA's safety and effectiveness standards had been met.
"The redesignation of surgical mesh by the FDA to a higher risk category does not otherwise effect [sic] products approved in the past or those that are currently on the market, nor does it impose any further requirements on manufacturers clinicians to use these devices in any different way to that previously required," Jessamine said in the email.
"The key issue is communication with the patient to explain the surgical procedure, what is proposed to be used in that procedure and what are the risks and benefits of use of one particalr [sic] surgical approach or material against another," he continued.
"This requirement for disclosure and communications has always been in place and the FDA redesignation does not change or increase it."
Another email from Jessamine referring to research commissioned by the executive arm of the European Union also demonstrated the selective approach MedSafe had when considering and endorsing information on surgical mesh.
Dated November 6 2014, the email was written 18 months before the Health Committee published its recommendations.
"If no health select committee reconsideration by the time the SCENHIR [Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission] is published, I would be pushing for us to propose that the Minister [Coleman] consider not supporting Select committee reconsideration at all, (obviously this depends on result of European report)," Jessamine said.
WHERE ARE WE NOW
Since meeting with Korte and Sullivan, Coleman has decided to "check" whether advice he has received from "the officials" has been correct.
When asked why he had not done this earlier, Coleman said he had been unaware of any dissatisfaction regarding the implementation process.
"The first was that this was raised as a new and unresolved issue has been in the past two weeks," he said last Monday [July 31].
"We had that [public] meeting on Friday the 14th of July, I was away for the next week, and then I met with them [Korte and Sullivan] last Friday [June 28th]."
However, Coleman - either directly or through his staff - received and answered numerous queries on surgical mesh from constituents like Korte and Sullivan, as well as fellow MPs, in the past six months.
Following his interview, Coleman also sent Newsroom a document outlining the "timeline" for committee recommendations, dated May 31, 2017.
The document referred to various discussions between health authorities and medical bodies, new ACC and Medsafe forms, updated information on surgical mesh on the Medsafe site, as well as the development of new therapeutics legislation for New Zealand.
It did not specify:
* If and when a national surgical mesh registry would be created
* What, if any, expansion of Medsafe's role would occur to enable it to assess the quality and safety of a medical device before it is used in New Zealand
* Any outcome regarding a review into best practice and the informed consent process for surgical mesh procedures
* Whether ongoing education of surgeons working with surgical mesh would be formalised
* Whether a consistent coding system for surgical mesh was being used by health practitioners so patients could be identified and monitored
When asked how long was needed to implement recommendations - particularly given the mounting number of injury claims - Coleman refused to identify a specific timeframe.
"I think the recommendations have or are in the process of being implemented, but I fully accept that...many things that are done by the Government may not happen as quickly as those who are affected by them would want them to happen," he said.
"It also reflects there's clearly a gap in the view of the people who I met...compared to the advice I'm getting from the Ministry. We just need to check whether that's resolvable - that or there may just be some differences in perception."
LINES IN THE SAND
Coleman's engagement with the issue, particularly in the past month, has pushed Korte and MDU to near breaking-point.
It's just not acceptable," Korte said. "These people's lives have been destroyed. How many more people's lives have to be ruined before the Government and Jonathan Coleman start listening?"
"He needs to either step up, or step aside."
"We need an independent commissioner to take charge, someone who is capable of fixing the problems associated with the surgical mesh issue and who can put patients first," she said.
Meanwhile, Coleman has dismissed the idea.
"We're not appointing an independent commissioner."
"I have not made a mistake. I have the deepest sympathy for all those people who have been affected by this," he said.
https://www.newsroom.co.nz/2017/08/06/41379/surgical-mesh-a-decade-of-debilitation
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Woman who lives in constant pain calls for op to be banned
Aug 4, 2017 | Bexhill Observer
A woman who lives her life in excruciating pain after a medical operation four years ago, joined other women at Parliament last month in a campaign to get the surgical procedure banned in the UK.
The Sling the Mesh Campaign is calling for an operation using pelvic mesh implants to be banned after thousands of women suffered serious health complications.
Deborah Wood, of Bexhill, underwent an operation in 2013 but after experiencing numerous negative side-effects, including extensive bleeding and extremely painful sexual intercourse, she began the process of having the mesh removed.
She said: “I have had five operations to remove the tape and I still have a small amount of tape and arms left in. I don’t think I can go through anymore operations.
“For the past four years, I have been in chronic pain 24/7. I have nerve damage in my legs – the pain in my legs is constant, they feel like someone is driving red hot glass into my legs. I get a lot of pain in my vagina and my pubic bone. I don’t have any sensation in my bladder so I can’t tell when it is full or empty, I have to use catheters.
“I am now left permanently disabled. I cannot walk very far, I need to use crutches, a wheelchair and mobility scooter. I have just been diagnosed with PTSD and I am now on antidepressants.
“I am now left permanently disabled. I cannot walk very far, I need to use crutches, a wheelchair and mobility scooter. I have just been diagnosed with PTSD and I am now on antidepressants.
“Before all of this happened I was at university getting a degree in photography and had a photography studio. I had to give that all up.
“Before all of this happened I was at university getting a degree in photography and had a photography studio. I had to give that all up.
“I am 49 years old and the thought I have to live the rest of my life in pain scares me.”
Deborah travelled to London on July 18 with other members of the Sling the Mesh Campaign to meet with Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh surgery.
The mesh patch or vaginal tape, also known as TVT, TVTO and TOT, are used to treat incontinence and prolapse, often caused by childbirth. Politicians called for mesh operations to be suspended in Scotland in June 2014 and in May 2017, Scottish health secretary Shona Robison called for an independent expert to review a mesh safety report. The English mesh review was due out at the end of July 2017.
Deborah added: “The TVT/TOT must stop in the UK. We need to get the public aware to prevent more horrific injuries. This mesh has ruined my life.”
http://www.bexhillobserver.net/news/health/woman-who-lives-in-constant-pain-calls-for-op-to-be-banned-1-8087506
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Anguish of women who received vaginal mesh treatment
Aug 7, 2017 | The Glamorgan Gem
By Tim Chapman
A Barry woman has told The GEM of the anguish and pain suffered by some patients who have received vaginal mesh implants.
Women who received the treatment suffered serious health problems and endured bouts of depression.
The implants were inserted into women suffering from health problems such as incontinence or prolapse, caused by childbirth or hernias. Men can also receive the implants.
Pauline Inch attended a parliamentary meeting at Westminster on July 18 hosted by Owen Smith, the MP for Pontypridd which was addressed by leading gynaecologists, urologists, and ‘Sling the Mesh’ campaigner Kath Sansom.
Pauline, who knows of sufferers in Barry and Bridgend, told The GEM: “The meeting in Parliament was chaired by Owen Smith and there was a panel of eminent surgeons.
“It was well attended by over 120 women from all over the country who had suffered from an implant at some time in their lives.
“We heard that incidents had been under-reported because staff were worried how it would reflect on them.
“We also heard that the old way of surgery had very little failures compared to the mesh method, but the mesh was deemed cheaper and more cost effective.
“Even that has not been really true because of the additional cost of medication to help the patient through the painful life that they have to endure afterwards.”
Alternatives treatments can include using ‘bulking agents’ such as collagen, pessaries or tissue grafts.
One consultant urogynaecologist told the meeting that there is a better way of solving the problem.
Pauline said: “There always was, so why was it ignored? Only 40 per cent of surgeons reported their results to the authorities, so the problem was played down, and the plight of women victims rejected.
“These women had to suffer physical and mental pain while their bodies rejected the intruder inside of them which was releasing toxins inside their bodies.
“Some of the medication didn’t help their mental state, which was compounded by some of their GPs telling them that the pain was psychosomatic.”
Pauline said that during the meeting, some of the women were able to recount stories about how devastated their lives had been following treatment.
She said: “The women were allowed to voice their feelings, and for two hours we listened to the torture that these ladies had to endure.
“The stories told at that meeting left most in the room with tears in their eyes, men in the room openly crying while listening to the ordeals of some women. “One woman from north Wales told the assembled group that she was an outdoor person who regularly went walking in the mountains of Wales with her husband and daughter before her operation; now she is a wreck, unable to walk down to the high street to shop, let alone climb a mountain.
“When she first started to suffer from the symptoms of mesh, she was told that ‘it was all in her mind’, and just get on with her life.
“This lady doubted herself, and was twice put into care for mental issues; she also tried to kill herself to end the pain.
“Another told of the suffering experienced by the husbands and families of victims, it was not just the patient who suffered.
“Her husband was a ‘brick’ to her, and stood by her through the many years that she suffered. They hadn’t had sex for years due to the extreme pain that she was in.
“She also told the meeting that her daughter had been seven years told when her mother had had the operation and had been a normal outgoing child, but now, at the age of 15, had been self-harming for three years. This was due to the stress of seeing her mother living the way she is, slowly losing the mother that she knew and loved.”
Pauline said a GP told the meeting that colleagues had been ignorant of issues surrounding the mesh treatment and he was trying to educate them and surgeons on its failings. All GPs had been able to do was refer women back to specialists who had caused the problem in the first place.
Pauline says she suffers horrendous pain. “The top of my legs hurt, my groin feels as if it has barbed wire in there, and it’s as if someone’s put a hatchet in my lower back.”
When she spoke to one surgeon about removing her mesh, he told her: “There’s nothing that can be done. No surgeon would come near you.”
The problem is too complex. Pauline’s mesh is now embedded in her abdominal walls, part of her bowel and her organs.
Prior to the meeting, Owen Smith said: “In seven years of being an MP, this is one of the worst medical issues I have come across.
“I was first contacted by a constituent suffering from chronic pain as a result of the procedure, and since getting in touch with the ‘Sling the Mesh’ campaign I have been contacted by countless women who have shared their devastating stories following mesh surgery.
“It is my hope that the Government will take action to address this growing issue and immediately review mesh treatment.”
An NHS England Mesh Working Group report has been issued and Mr Smith said: “Mesh-injured women will be deeply disappointed by the outcomes of the final NHS England Review, which seems to have made little progress since its interim report came out over a year ago.
“This was an opportunity for the NHS to take a lead and recommend a pause in the use of mesh until we know precisely how many women have been adversely affected by the product.
“Instead, they appear content to allow mesh to be widely used despite growing, international concerns about its potential ill effects.
“The only people pleased with this report will be the medical device companies who marketed mesh so diligently and who now fear mass litigation. Many companies have already taken their mesh products off the market, that alone should tell us something is not right with these devices.”
http://www.glamorgan-gem.co.uk/article.cfm?id=115096&headline=Anguish%20of%20women%20who%20received%20vaginal%20mesh%20treatment§ionIs=news&searchyear=2017
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Move to address concerns over vaginal mesh implants
Aug 7, 2017 | Derry Journal
The Department of Health has confirmed it is looking at addressing the “distressing side-effects” affecting some local women fitted with vaginal mesh implants.
A Sinn Féin delegation recently met with a group representing women from across the North suffering serious side effects from vaginal mesh implants, which are used to treat prolapse and incontinence in women, often after childbirth.
Sinn Féin Foyle MLA Karen Mullan said the women related “harrowing and personal accounts of their experiences and the devastating effects it has had on their health” and called for clarity on how this will be addressed. She said: “The group raised a number of issues and concerns around the use of mesh implants and we intend to raise these concerns directly with the Department of Health. The physical and emotional pain they have had to endure is terrible. It’s important that the health and wellbeing needs of women affected by mesh implants are met as a matter of urgency.”
A Department of Health spokesperson said: “The Department has been engaging with the Health and Social Care Board and the Public Health Agency regarding the ongoing concerns of women who are experiencing adverse effects following these procedures. The HSCB and the PHA are identifying the clinical pathways available for women locally who are experiencing distressing effects and are engaging with local clinicians in developing a consistent high quality approach throughout Northern Ireland.”http://www.derryjournal.com/news/move-to-address-concerns-over-vaginal-mesh-implants-1-8087441
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