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Ethicon Media Monitoring 7/24/2017

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

    Jul 21, 2017 | Mesh Medical Device Newsdesk

    Canadian, Nonie Wideman, is a survivor of medical complications from synthetic medical mesh.
  2. Johnson & Johnson alleged to have reduced asset exposure linked to women's legal case

    Jul 24, 2017 | Newcastle Herald

    By Joanne McCarthy

    WOMEN pelvic mesh victims suing Johnson & Johnson in one of Australia’s largest health class action legal cases are seeking urgent answers after a report saying the multinational drug company has reduced the pool of assets available if more than 700 women win.
  3. Vaginal mesh: What YOU should know about the controversial urinary incontinence cure

    Jul 21, 2017 | Express.co.uk

    By Lauren Clark

    VAGINAL mesh implants are used to treat urinary incontinence or pelvic organ prolapse - a condition where one or more of the pelvic organs bulges into the vagina, causing symptoms of backache, heaviness or a dragging discomfort.
  4. St Albans campaigner calls for end to pelvic mesh procedures

    Jul 22, 2017 | Herts Advertiser

    By Anne Suslak

    A St Albans woman who suffered debilitating pain after having a pelvic mesh fitted is lobbying Parliament for an urgent suspension of the procedure.
  5. 515 procedures involving use of controversial vaginal mesh implants to treat incontinence and prolapse

    Jul 24, 2017 | Derry Journal

    By Kevin Mullan

    A controversial procedure used to treat incontinence (SUI) and pelvic organ prolapse (POP) following child birth has been carried out over 500 times on women in the North West over the past five years, the ‘Journal’ has learned.
  6. 'IT'S AGONY'Mum who wet herself EVERY DAY after giving birth has op to fix it – but now finds sex so painful she told her husband to sleep with someone else

    Jul 20, 2017 | The Sun

    By Andrea Downey

    Cat Lee opted to be fitted with a controversial vaginal mesh implant but claims it left her in crippling pain
  7. Mum left unable to have sex following childbirth told husband to sleep with somebody else

    Jul 24, 2017 | The Huddersfield Examiner

    By Anna Roberts

    A mum left in extreme pain and unable to have sex following child birth told her husband to have sex with somebody else.

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

    Jul 21, 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.”The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

    Nonie Wideman, Contributor

    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.”

    Mesh removed from LR after 3 months

     The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

    by Nonie Wideman, April 2013Background

    When 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 )”

    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.  #

    http://www.meshmedicaldevicenewsdesk.com/the-links-between-surgical-mesh-complications-and-the-development-of-autoimmune-diseases/

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  2. Johnson & Johnson alleged to have reduced asset exposure linked to women's legal case

    Jul 24, 2017 | Newcastle Herald

    By Joanne McCarthy

    WOMEN pelvic mesh victims suing Johnson & Johnson in one of Australia’s largest health class action legal cases are seeking urgent answers after a report saying the multinational drug company has reduced the pool of assets available if more than 700 women win.

    Finance commentator Michael West said an investigation of Johnson & Johnson’s tax affairs and financial statements shows a deed of cross guarantee between seven of the company’s subsidiaries has been allowed to lapse, potentially restricting available funds if the women’s case succeeds.

    The company’s legal firm advised the Australian Securities and Investments Commission in a letter uncovered during the investigation, Mr West said. Until 2017 the seven subsidiaries had guaranteed each others’ debts.

    The investigation also revealed the subsidiaries had failed to file accounts, in breach of the Corporations Act.

    One of the women registered in the class action, Jo Manion, said women were shocked by the report and had contacted their legal firm, Shine Lawyers, for answers.

    “Johnson & Johnson’s record of accountability on mesh is not good so we are concerned by this report and we want to know what’s going on,” Ms Manion said.

    “I think it’s fair to say that the history of women and Johnson & Johnson on mesh is that they just want the whole issue to go away.”

    Johnson & Johnson communications director Meshlin Khouri did not respond directly to Mr West’s claim that the lapsed deed of cross guarantee would restrict available funds if the women win.

    In a statement on Sunday to the Newcastle Herald, Ms Khouri said the company did not agree that matters raised by Mr West had been “properly reported”, but they had been “addressed and resolved with ASIC” and were “unrelated to the litigation”.

    “The financial position of Johnson & Johnson Pty Ltd and its subsidiaries, including Johnson & Johnson Medical Pty Ltd, has not changed as a consequence.”

    Ms Khouri said the company believed the pelvic mesh class action would “show we have acted ethically and responsibly in the research, development and supply of these products”.

    In his report Mr West noted that Johnson & Johnson paid a “reasonable amount of tax” when compared with other multinationals operating in Australia. Over 10 years the company paid $238 million in income tax based on $12 billion in revenue, he found, in an investigation of 20 multinationals sponsored by GetUp! and the Tax Justice Network.

    In America more than 50,000 women are suing the company because of serious injuries they allege occurred after mesh surgery. Johnson & Johnson announced it would appeal a $20 million judgment awarded to one woman in April, after a jury found the company’s TVT-Secur mesh device was defectively designed and caused the woman’s injuries. The jury also found the company failed to provide adequate warnings about the risks. 

    TVT-Secur is one of nine Johnson & Johnson mesh devices subject to the Australian class action, which was cleared for use in Australia in October, 2006 but withdrawn by the company and cancelled by the Therapeutic Goods Administration (TGA) in May, 2012.

    Johnson & Johnson continues to market three incontinence mesh devices in Australia that are implanted via the vagina, all classified as IIb or medium to high risk by the TGA, after satisfying requirements of safety and efficacy.

    http://www.theherald.com.au/story/4807072/questions-over-mesh-moves/

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  3. Vaginal mesh: What YOU should know about the controversial urinary incontinence cure

    Jul 21, 2017 | Express.co.uk

    By Lauren Clark

    VAGINAL mesh implants are used to treat urinary incontinence or pelvic organ prolapse - a condition where one or more of the pelvic organs bulges into the vagina, causing symptoms of backache, heaviness or a dragging discomfort.

    Surgery to treat pelvic organ prolapse is relatively common, according to the NHS.

    They estimate that one in ten women will undergo such a procedure for the condition by the time they’re 80 years old.

    However, the surgery is not always successful, and the prolapse - and its painful symptoms - can return.

    In these cases women are offered a vaginal mesh, also called a sling implant.

    It’s used to support the vaginal wall and sometimes the internal organs, such as the bladder, womb or bowel.

    There are approximately 1,500 of these quick operations carried out every year.

    As well as pelvic organ prolapse, they can be used to treat urinary incontinence - where urine leaks involuntarily.

    According to the NHS, most women respond well to the quick treatment.

    However, there have been reports from a significant number of traumatic complications to the Medicines and Healthcare products Regulatory Agency (MHRA), the government watchdog.

    These include persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel.

    According to the BBC’s Victoria Derbyshire programme, more than 800 women claim the treatment has affected their quality of life.

    However the treatment - which involves an operation where the vagina is opened at the vaginal wall to secure the mesh in place - is not life-threatening.

    At a meeting in parliament this week, after a group of UK patients began class action against manufacturers, senior doctors called for a public inquiry into its use. 

    This comes after a recent study published in the journal Lancet which showed the readmission rate for one form of mesh surgery for prolapse was 19 per cent.

    Additionally, a report by the MHRA revealed that there was a one to two per cent of pain or “erosion” for mesh procedures for incontinence.

    Other options for treating pelvic organ prolapse include pelvic floor exercises, hormone replacement therapy, vaginal pessaries or hysterectomy.

    https://www.express.co.uk/life-style/health/831399/vaginal-mesh-vagina-implant-pelvic-organ-prolapse-urinary-incontinence-treatment

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  4. St Albans campaigner calls for end to pelvic mesh procedures

    Jul 22, 2017 | Herts Advertiser

    By Anne Suslak

    A St Albans woman who suffered debilitating pain after having a pelvic mesh fitted is lobbying Parliament for an urgent suspension of the procedure.

    Lara Edgar, a 42-year-old mum from St Albans, had a TVT (transvaginal tape) fitted at St Albans Hospital in January this year, for mild stress incontinence following the birth of her daughter. She had to have the mesh privately removed in Oxford after it caused her chronic pain.

    Alongside other women from the Sling the Mesh campaign, Lara lobbied Parliament on Tuesday, July 18.

    She said: “The consultant urogynaecologist explained it was a minor day procedure involving two small incisions and placing some tape under my urethra and that I would be back to normal within one to two weeks.

    “Rather than enjoying running without having to worry about any embarrassing leaks, what actually followed was months of debilitating chronic pain.

    “I’m still in pain but hope to be able to pick my life up again soon.”

    The meeting at Downing Street was addressed by Owen Smith MP, who is the shadow Northern Ireland secretary, alongside obstetrician and gynaecologist John Osborne, mesh removal surgeon Sohier Elneil and Sling the Mesh campaigner Kath Sansom.

    Lisa Hunter, 46, from Borehamwood, also had a TVT fitted at St Albans Hospital in January. She initially had a hernia mesh fitted in 2004 which caused her chronic pain, and was given a hysterectomy which doctors believed would fix the problem. The hysterectomy led to stress incontinence, so she had the TVT fitted.

    She said: “I feel 12 years down the line that I have a substandard device inside me which is debilitating. Compounded with that I have now got the TVT mesh.

    “I am on the list to have the TVT removed. I have got to find a consultant who is willing to take the hernia mesh out.

    “I feel that I have lost my womb and my uterus through a fishing expedition. I can’t hold down a full time job because of hospital appointments. I have been into A&E because the pain has been so severe.”

    There are now more than 2,200 members of Sling the Mesh, which has launched a group action with London firm Wedlake and Bell with QC Elizabeth Ann Gumbel.

    http://www.hertsad.co.uk/news/st-albans-campaigner-calls-for-end-to-pelvic-mesh-procedures-1-5117408

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  5. 515 procedures involving use of controversial vaginal mesh implants to treat incontinence and prolapse

    Jul 24, 2017 | Derry Journal

    By Kevin Mullan

    A controversial procedure used to treat incontinence (SUI) and pelvic organ prolapse (POP) following child birth has been carried out over 500 times on women in the North West over the past five years, the ‘Journal’ has learned. 

    The use of vaginal mesh implants to treat SUI and POP has been suspended in Scotland since 2014, amid claims their use can lead to side effects, including chronic pain, in up to 10 per cent of women who undergo the procedure. 

    This week 60 women, led by Banbridge native Jackie Harvey, visited Westminster and called on MPs to ban the use of synthetic tape entirely. However, the ‘Journal’ has learned that the procedure remains a routine treatment for the conditions in the Western Trust and elsewhere in the North. 

    Figures released by the local health authority under Freedom of Information legislation show that 515 procedures were carried out on woman in the North West between April 2012 and April 2017. Four hundred and ten procedures involved the introduction of tension free vaginal tape while 18 procedures involved the removal or partial removal the tape. 

    A further 81 related procedures also involving the use of mesh were carried out during the same period. 

    While the Royal College of Obstetricians and Gynaecologists (RCOG) has acknowledged “there is some controversy over the use of mesh” and that significant complications may arise for some women its view is that it is still the most “effective form of treatment for the distressing effects of SUI and POP” for many women. The RCOG recommends operations using mesh should only be performed by specialists with expertise in the technique, and only after a full discussion with the patient. 

    http://www.derryjournal.com/news/515-procedures-involving-use-of-controversial-vaginal-mesh-implants-to-treat-incontinence-and-prolapse-1-8064846

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  6. 'IT'S AGONY'Mum who wet herself EVERY DAY after giving birth has op to fix it – but now finds sex so painful she told her husband to sleep with someone else

    Jul 20, 2017 | The Sun

    By Andrea Downey

    Cat Lee opted to be fitted with a controversial vaginal mesh implant but claims it left her in crippling pain

    A MUM-of-two claims she is unable to have sex with her husband after she was fitted with a controversial vaginal mesh implant.

    Cat Lee, 43, opted to have the op after she suffered severe incontinence following the birth of her second child, but says it has "ruined her life".

    The net-like implant is used to treat incontinence or prolapse, conditions often caused by childbirth.

    But the implants have left some women in excruciating pain, unable to walk or have sex.

    Cat, a former Huddersfield University lecturer, was left in so much pain she even suggested her husband, Gordon, could sleep with someone else.

    She said: “My poor husband was more like my carer.

    “As for sex, it was strictly out of bounds because of the pain.

    “I even suggested he could sleep with someone else. Luckily, he refused, saying it was me he loved.”

    Cat experienced severe morning sickness and incontinence throughout her pregnancy but was keen to return to work as a visual culture lecturer after giving birth to Charlie at Calderdale Royal Hospital, near Halifax in 2007.

    Gordon, 46, who works in web support, stayed at home to look after their son.

    But Cat was mortified when her incontinence became so unmanageable that she wet herself at work.

    She recalled: “I was so ashamed and humiliated.

    “I’d gone back to work, six months after having Charlie, but I was still wetting myself.

    “On this occasion, as I marched across the campus, I felt a rush between my legs.

    “I’d wet myself and it had soaked right through the pad I’d been wearing.

    “I was only 33, but I felt like a granny.

    “I even had to ask a colleague to buy me some new tights, although I was too embarrassed to tell her why.”

    Cat, who also has a 21-year-old daughter, Tash, went to her GP for help.

    She was referred to a gynaecologist at Calderdale Royal Hospital, part of Calderdale and Huddersfield NHS Foundation Trust.

    Cat, who was planning to study for a PhD, was told she had stress incontinence and a minor prolapse, which was affecting her bladder control.

    She said: “I was fine when I had Tash, but with Charlie, I lost count of the times I wet myself when I was pregnant.

    “Afterwards, though, it got worse and worse.

    “Wetting myself at work was the final straw.”

    When she was offered vaginal mesh surgery she jumped at the chance.

    She added: “I was told it was a 20-minute procedure and, if it ended the misery of incontinence, it would transform my life.

    “It was a type called TVTO, or Tension-Free Vaginal Tape Obturator.”

    She had the surgery on December 2, 2009 at Huddersfield Royal Infirmary – two weeks after her wedding to Gordon near their Hebden Bridge home.

    She said: “Gordon and I had known each other for 22 years and he’d proposed five years earlier at a local train station.

    “He was my soul mate, so there’d been no rush to get married.

    “Charlie was an adorable page boy, while I felt like a Hollywood siren, in a silky burgundy gown.

    “We decided not to have a honeymoon until after the operation, when, hopefully, we’d go somewhere I could swim in the sea.”

    Cat thought the surgery would be the answer to her problems, but when she woke after the surgery she felt an intense burning, acid-like pain starting one the left side of her groin, spreading to the right side.

    She was given painkillers and assumed it must be a normal side effect of the surgery.

    She was discharged that day and told to rest for six weeks.

    But she claims her pain never went away.

    In March 2010 she returned to work but claims while the incontinence was cured she could barely walk because of the burning feeling in her groin.

    She said: “I was in crippling pain, unable to walk or stand properly.”

    Cat was referred back to Huddersfield Royal Infirmary by her GP, where she was told the implant could take a year to settle.

    As her pain persisted for the next few years, Cat researched the mesh implant and claims she discovered that some could cut into the vagina and cause severe discomfort.

    She recalled: “By September 2011 – two years after the operation – I couldn’t even sit down because of the pain.

    “Finally, at the end of 2012, I was referred to another hospital in Leeds for steroid injections and a Vaginal Wall Prolapse Repair – a procedure to repair the sinking of the vaginal wall.

    “Still nothing worked and the pain persisted.”

    In the summer of 2013, at her wits’ end, Cat retired because she was too unwell to work.

    She kept researching her symptoms online.

    She added: “I discovered a Harley Street doctor in London, who specialised in removing my type of mesh, for £10,000.

    “We’d already started legal action against Calderdale and Huddersfield NHS Foundation Trust, who run both Calderdale Royal Hospital and Huddersfield Royal Infirmary, so they agreed to pay the money as an interim payment and I went under the knife.”

    The doctor was able to remove most of the mesh, but Cat still claims she is in severe pain and has to use a mobility scooter to get around.

    She said: “Ten years on, I’m convinced that the so-called ‘simple’ vaginal mesh surgery has ruined my life.

    “Luckily, we didn’t want any more kids, but I don’t feel like proper mum to Charlie.

    “I can only do the school run a few times a week and then, he has to walk alongside me in my mobility scooter.

    “I can’t play with him like other mums and I don’t feel like much of a wife either.”

    This year Calderdale and Huddersfield NHS Foundation Trust paid Cat and family £375,000 to settle their legal claim.

    Cat has now joined the Sling the Mesh campaign, calling for implant operations to be stopped.

    Hundreds of women are taking legal action against the NHS and the makers of vaginal mesh implants.

    Cat said: “I want to help other women like me.

    “Since the operation, my life has been turned upside down.

    “I’m convinced the mesh is the reason why.

    “I don’t want another child like Charlie seeing their mum go through this.”

    Brendan Brown , Calderdale and Huddersfield NHS Foundation Trust’s director of nursing, said: “Clearly this has been a distressing experience for Ms Lee.

    “We have agreed a settlement out of court and as a result we are unable to comment further on this case.”

    https://www.thesun.co.uk/living/4059202/mum-who-wet-herself-every-day-after-giving-birth-has-op-to-fix-it-but-now-cant-face-sex-because-its-agony/

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  7. Mum left unable to have sex following childbirth told husband to sleep with somebody else

    Jul 24, 2017 | The Huddersfield Examiner

    By Anna Roberts

    A mum left in extreme pain and unable to have sex following child birth told her husband to have sex with somebody else.

    Cat Lee, 43, was left with severely impaired bladder control after the birth of her second child, Charlie, on September 29, 2007.

    She had a vaginal mesh fitted as treatment - but it caused severe pain and left her unable to sit down or have sex.

    Former Huddersfield University lecturer Cat said: “My poor husband, Gordon, was more like my carer.

    “As for sex, it was strictly out of bounds because of the pain.

    “I even suggested he could sleep with someone else. Luckily, he refused, saying it was me he loved.”

    Experiencing severe morning sickness and incontinence throughout her pregnancy,

    Cat, of Hebden Bridge, was keen to return to work as a visual culture lecturer, after having Charlie at Calderdale Royal Hospital, near Halifax.

    She was the main breadwinner, while Gordon, 46, who works in web support, stayed at home to look after their son.

    But Cat was mortified when her incontinence became so unmanageable that she wet herself at work.

    Recalling the incident, she said: “I was so ashamed and humiliated.

    “I’d gone back to work, six months after having Charlie, but I was still wetting myself.

    “On this occasion, as I marched across the campus, I felt a rush between my legs.

    “I’d wet myself and it had soaked right through the pad I’d been wearing.

    “I was only 33, but I felt like a granny. I even had to ask a colleague to buy me some new tights, although I was too embarrassed to tell her why.”

    Following her humiliating incident at work, Cat - who also has a daughter, Tash, 21, from a previous relationship – saw her GP. He referred her to a gynaecologist at Calderdale Royal Hospital, part of Calderdale and Huddersfield NHS Foundation Trust.

    Cat, who was planning to study for a PhD, was told she had stress incontinence and had a minor prolapse, which was affecting her bladder control.

    She said: “I was fine when I had Tash, but with Charlie, I lost count of the times I wet myself when I was pregnant.

    “Afterwards, though, it got worse and worse. Wetting myself at work was the final straw.”

    When she was offered vaginal mesh surgery – a net-like implant used to treat pelvic organ prolapse and incontinence after childbirth – she jumped at the chance.

    She recalled: “I was told it was a 20-minute procedure and, if it ended the misery of incontinence, it would transform my life.

    “It was a type called TVTO, or Tension-Free Vaginal Tape Obturator.”

    The surgery was scheduled for December 2, 2009 at Huddersfield Royal Infirmary – two weeks after her wedding to Gordon, at Todmorden Town Hall, near their Hebden Bridge home.

    She said: “Gordon and I had known each other for 22 years and he’d proposed five years earlier at a local train station. He was my soul mate, so there’d been no rush to get married.

    “We were married on November 21, 2009 and it was a perfect day.

    “Charlie was an adorable page boy, while I felt like a Hollywood siren, in a silky burgundy gown.

    “We decided not to have a honeymoon until after the operation, when, hopefully, we’d go somewhere I could swim in the sea.”

    With her surgery imminent, Cat felt like everything in her life was falling into place.

    But, when she woke from the anaesthetic on December 2, 2009, she experienced an intense burning, acid-like pain, starting in her left groin and spreading to the right side.

    Given painkillers, she thought this must be normal after surgery. Discharged that day she was told to rest for six weeks.

    Sadly, though, according to Cat, the pain never went away.

    She said: “Despite spending days in bed, the pain was still as intense and debilitating for years after.”

    In March 2010, she returned to work, but claims, while the incontinence was cured, she could barely walk, because of the burning feeling in her groin.

    “I was in crippling pain, unable to walk or stand properly,” she said.

    Referred back to Huddersfield Royal Infirmary by her GP, she was told the implant could take a year to settle.

    As her pain persisted for the next few years, Cat researched the mesh implant and claims she discovered that some could cut into the vagina, causing severe discomfort.

    She said: “By September 2011 – two years after the operation - I couldn’t even sit down because of the pain.

    “Finally, at the end of 2012, I was referred to another hospital in Leeds for steroid injections and a Vaginal Wall Prolapse Repair - a procedure to repair the sinking of the vaginal wall. Still nothing worked and the pain persisted.”

    By the summer of 2013, at her wits’ end, Cat retired because she was too unwell to work.

    With time on her hands, she continued researching vaginal mesh surgery.

    “I discovered a Harley Street doctor in London, who specialised in removing my type of mesh, for £10,000,” she recalled.

    “We’d already started legal action against Calderdale and Huddersfield NHS Foundation Trust, who run both Calderdale Royal Hospital and Huddersfield Royal Infirmary, so they agreed to pay the money as an interim payment and I went under the knife.”

    Despite the doctor removing most of the mesh, Cat, who now uses a mobility scooter, claims the pain remains severe.

    “Ten years on, I’m convinced that the so-called ‘simple’ vaginal mesh surgery has ruined my life,” she continued.

    “Luckily, we didn’t want any more kids, but I don’t feel like proper mum to Charlie.

    “I can only do the school run a few times a week and then, he has to walk alongside me in my mobility scooter.

    “I can’t play with him like other mums and I don’t feel like much of a wife either.”

    Cat claims all the surgery has also made her incontinence worse.

    “I’m even more incontinent now than I was before,” she despaired.

    “This year, Calderdale and Huddersfield NHS Foundation Trust settled our legal claim, without admitting liability, paying me £375,000, minus the £10,000 for the Harley Street op.

    “But that doesn’t make up for eight years I have lost.

    “I’m now registered disabled, unemployed and can’t even go out for drinks with my girlfriends. “

    Cat, who says other women have also complained to the NHS, or the device manufacturer, about problems with the mesh implant, has now joined the Sling the Mesh campaign, calling for implant operations to be stopped.

    “I want to help other women like me,” she added. “Since the operation, my life has been turned upside down. I’m convinced the mesh is the reason why.

    “I don’t want another child like Charlie seeing their mum go through this.”

    Calderdale and Huddersfield NHS Foundation Trust’s director of Nursing, Brendan Brown, said: “Clearly this has been a distressing experience for Ms Lee. We have agreed a settlement out of court and as a result we are unable to comment further on this case.”

    http://www.examiner.co.uk/news/mum-left-unable-sex-following-13358826

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