Preview Newsletter
Ethicon 11/27
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Individuals Are Filing Lawsuits for Faulty Hernia Mesh Products
Nov 24, 2017 | Urban Twist
A hernia repair requires two important things: a good doctor and trusty mesh products. -
Vaginal mesh operations should be banned, says NICE
Nov 27, 2017 | BBC News
By Anna Collinson
The health watchdog NICE is to recommend that vaginal mesh operations should be banned from treating organ prolapse in England, the BBC's Victoria Derbyshire show has learned. -
Call for suspension of vaginal mesh implants following rise in 'severe pain' complaints
Nov 24, 2017 | ITV
Many women who have had a vaginal mesh implant say they cause severe pain and the side effects of having one are worse than the conditions they are intended to alleviate. -
Daughter Fighting Late Mother’s Pelvic Mesh Case
Nov 27, 2017 | Mesh Medical Device News Desk
Mary Dickson plans to go up against healthcare giant, Johnson & Johnson over its pelvic mesh on behalf of her late mother, Vada Mae Smith, unless she can find a law firm to take her case. -
The mesh scandal is ‘institutional denial’ says lawyer following Parliamentary speech saying mesh injured women cost the NHS hundreds of thousands in long term care
Nov 24, 2017 | Cambs Times
By Kath Sansom
Sling The Mesh made it to the budget speeches in Parliament this week when MP Emma Hardy spoke of the Government’s short sightedness on the vaginal mesh implant scandal. -
Scores of women say top UK surgeon left them with traumatic complications
Nov 24, 2017 | The Guardian
By Hannah Devlin
A group of 100 women are considering legal action against Britain’s most influential pelvic surgeon, claiming that operations he conducted left them with traumatic, life-altering complications. -
Surgeon investigated over allegations women suffered 'years of severe pain' after operations
Nov 25, 2017 |
By Henry Vaughan and Catherine Wyatt
A surgeon is under investigation over allegations that women suffered "years of severe pain" after his operations. -
Mum says she bled every day for almost five years and blames it on a mesh implant
Nov 25, 2017 | Wales Online
By Amy Coles
A mum says her life was ruined after she experienced bleeding every day for nearly five years which she blames on a medical mesh implant. -
'It had cut up my insides like glass': Mum says she bled every day for almost five years after mesh implant disintegrated in her stomach
Nov 26, 2017 | The Mirror
By Amy Coles
A mother says she was left in agony and bled every day for almost five years after a mesh implant disintegrated and turned hard like glass. -
'It's just soul destroying': when pelvic surgery goes wrong
Nov 24, 2017 | The Guardian
By Hannah Devlin
“Nobody wants to talk about toilet function at the best of times,” says Jacqui Shaw. “It’s just one of those topics people, especially ladies, want to keep to themselves.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Individuals Are Filing Lawsuits for Faulty Hernia Mesh Products
Nov 24, 2017 | Urban Twist
A hernia repair requires two important things: a good doctor and trusty mesh products. These requirements are basic things and hernia repairs are incredibly common. However, it appears that things don’t always go as they are supposed to, and numerous lawsuits have been filed after faulty mesh products led to reoperations.
For those who do not know, hernia occurs when an organ or a tissue exists abnormally through a hole in the muscle or tissue around it.
A hernia repair is not a complicated procedure and more than one million are performed every year in the United States. Inguinal hernias are the most common, and they occur in the inner groin. Thanks to laparoscopic methods, patients can recover a lot faster and there is less pain.
Faulty mesh products
An increasing number of patients have come forward and accused the Ethicon company of creating defective mesh products. There have been numerous persons who reported reoperations, serious injuries and even deaths as a consequence of the Physiomesh product.
Back in May 2016, an “Urgent Field Safety Notice” was issued by Johnson & Johnson after it was noticed that laparoscopic ventral hernia repairs that used the Ethicon Physiomesh Composite Mesh have recurrence/ reoperations rates that were unusually high.
The negative impact of the Ethicon Physiomesh Composite Mesh was identified thanks to two outcome tools that were application-oriented. These tools tracked the surgical outcomes from the entire nation and this became possible after The Danish Inguinal Hernia Database and the Herniamed German Registry allowed it. The worst part is that this product has been a global leader on the market ever since it appeared in 2010. In 2016 it was recalled, but it was already too late for many patients.
Legal action
After these reports became public, numerous other cases were discovered. As a consequence of that, many persons filed a physiomesh lawsuit. Lawsuits have been filed in many states and the number continues to grow.
Physiomesh is accused of creating numerous complications such as infection, pain, mesh migration, mesh contraction, perforation of the other tissues and organs or fluid build-up at the surgical site. Additionally, there has been bleeding, blockage of the small or large intestine and even fistula, the abnormal connection between intestines, vessels or organs.
Ethicon already recalled numerous Physiomesh products, but if you have already been harmed by this product, it is recommended to report all your complications to the Food and Drug Administration (FDA).
Make sure that you talk to your physician about this issue and see what you should do next since it differs from case to case.
Here is a list with all the recalled Ethicon Physiomesh products: ETHICON PHYSIOMESH™ Flexible Composite Mesh Rectangle 7.5cm x 15cm; ETHICON PHYSIOMESH™ Flexible Composite Mesh, Oval 10cm x 15cm; ETHICON PHYSIOMESH™ Flexible Composite Mesh, Square 15cm x 15cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Rectangle 15cm x 20cm, ETHICON PHYSIOMESH ™ Flexible Composite Mesh, Oval 15cm x 20 cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Oval 20cm x 25cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Rectangle 20cm x 30cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Oval 25cm x 35cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Rectangle 30cm x 35cm, ETHICON PHYSIOMESH™ Flexible Composite Mesh, Rectangle 30cm x 50cm.
Nevertheless, the Ethicon Physiomesh Open Flexible Composite Mesh Device is still available on the market and it continues to represent a risk for all the patients that went through a hernia repair. It is normal to have some doubts when it comes to this product since all the previous ones have been faulty and ineffective.
http://theurbantwist.com/2017/11/24/individuals-filing-lawsuits-faulty-hernia-mesh-products/
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Vaginal mesh operations should be banned, says NICE
Nov 27, 2017 | BBC News
By Anna Collinson
The health watchdog NICE is to recommend that vaginal mesh operations should be banned from treating organ prolapse in England, the BBC's Victoria Derbyshire show has learned.
Draft guidelines from NICE say the implants should only be used for research - and not routine operations.
Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.
One expert said it is highly likely the NHS will take up the recommendation.
However, the organisation is not compelled to act on findings it receives from NICE.
Both NHS England and NICE declined to comment.'Life-changing consequences'
In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".
It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".
One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.
"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.
"These can last from two to six hours at a time and is like having a heart attack," she said.
Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.
She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.
The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through".
The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.
They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".
He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.
But he said it had come too late.
"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."
He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.
In April, the BBC learned more than 800 UK women are taking legal actionagainst the NHS and the makers of vaginal mesh implants.
The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".
Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.
About one in 11 women has experienced problems, the data suggests.
The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.
Use of the implants to treat both organ prolapse and urinary incontinence has already been suspended in Scotland.
The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.
The Department of Health declined to comment.
Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.
http://www.bbc.com/news/health-42110076
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Call for suspension of vaginal mesh implants following rise in 'severe pain' complaints
Nov 24, 2017 | ITV
Many women who have had a vaginal mesh implant say they cause severe pain and the side effects of having one are worse than the conditions they are intended to alleviate.
The mesh implants are designed to help deal with incontinence and other problems following childbirth, yet a recent report says that around one in 10 women who have one experience problems with it.
As a result some MPs are calling for their immediate suspension, with a meeting held this week between MPs and campaigners, to urge the Government to suspend their use until more research is carried out.
Julie Gilsenan claims that her mesh implant has left her on a cocktail of medication to deal with the "knife"-life pain.
"It was the pain. I immediately noticed this pain," after the operation to fit it, she explained.
Ms Gilsenan continued that she asked medical staff "Why am I in this much pain?", but was told the pain was because she had undergone surgery.
But she added, "the pain got worse and worse.
"I felt like something had been left inside me.
"I felt like it was sticking through my groin.
"It was a really, really sharp pain like a knife through your groin."
MPs who oppose the mesh implants argue that the NHS is spending millions on drugs for women with adverse reactions.
One senior gynaecologist told ITV News she removes an average of eight implants each week due to complications.
"I would have personally liked to have seen all mesh surgery come to a halt, for us to review all of our data - because there's a lot of data in the system and we need to look at it - and come up with the real complications and risks and then go forward from there, " Dr Sohier Elneil explained.
"We do know some people may still need mesh, but not everyone does, certainly".
Sources at the Department of Health have conceded that there have been "some awful practice by some doctors which was causing distress to women", but said ministers had rejected the idea of a blanket ban, believing that the implants did help some women.
Around 120,000 women in England and Wales have had vaginal mesh implants, and some 500 women are now considering legal action against the manufacturers.
David Golten, a lawyer representing some of these women said that implants are not regulated in the same way as medicines.
"It is a failure and I think that the NHS and all the regulatory bodies and the Government are suffering from a case of institutional denial."
However, manufacturers of the implants and ministers have hit back at these claims, insisting that the implants help the vast majority of women who have had them fitted.
http://www.itv.com/news/2017-11-24/call-for-suspension-of-vaginal-mesh-implants-following-rise-in-severe-pain-complaints/
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Daughter Fighting Late Mother’s Pelvic Mesh Case
Nov 27, 2017 | Mesh Medical Device News Desk
Mary Dickson plans to go up against healthcare giant, Johnson & Johnson over its pelvic mesh on behalf of her late mother, Vada Mae Smith, unless she can find a law firm to take her case.
Vada Mae Smith spent most of her life in Summers County, West Virginia.
Her father, Daniel Green Sears, was a railroader and his wife handed one-month old Vada Mae over to Daniel on a street corner in Hinton W.V. a few days before Christmas 1942.
When he married, he would be able to gain official custody under West Virginia law, but that didn’t happened until Vada was four years old.
Eventually, the mother went on to marry a richer man who worked in the Chevrolet plant in Cleveland.
At the end of her mother’s life, Vada asked if she had ever done anything her mother was proud of. No, she was told.
Mary, Vada Mae’s daughter, says Vada suffered from abandonment issues all of her life.
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Vada’s DeathVada Mae and Zayden
Vada cleaned houses for a living. She had five children and gave them biblical names. Her husband, Robert Buckland, father of her children, died in May 1972 of a heart attack.
Vada Mae died September 13, 2016. The cause of death is listed as multisystem failure. No medications could address her antibiotic-resistant chronic infections.
Vada Mae Smith was 73 years old.
The last 16 years of Vada’s life was a living hell, says her daughter, spent in and out of the hospital and nursing homes.
Mary says her mother’s health declined after she received two transvaginal mesh implants, one in 2001 and another in 2006. Both were made by Ethicon, a division of Johnson & Johnson (J&J).
Mary Dickson is now the personal representative of her mother’s estate.
Mary reached out to MND to help tell her mother’s story and find someone to represent her mother in a possible wrongful death and product liability lawsuit against the healthcare giant. The case is set for trial in spring 2018.
Mary Dickson
Mary Dickson
The Smith complaint is filed in federal court in the Southern District of WV, (No. 2:15-cv-02800), where more than 104,000 defective product cases have been consolidated against seven manufacturers, alleging transvaginal mesh is defective.
It states a TVT (Tension-Free vaginal tape) was implanted in Vada Mae to treat incontinence by Dr. Michael Lassere, MD at Low Moore Virginia Columbia Alleghany Regional Hospital on August 17, 2001.
But Mary says she has found records that show the TVT Blue, used to treat incontinence, was implanted 70 days before it received the Food and Drug Administration’s 510(K) clearance for market.
She also found medical records that show a second mesh, a TVT-O, was implanted in 2006.
The original Smith complaint didn’t have the second mesh or the fact that the TVT Blue should not have been on the market.
The complaint did not contain the additional surgery Vada underwent in September 2002 to fix her prolapse, is missing two hospice recommendations that can be considered a cause of death; the 20 transfusions to address mysterious rectal and vaginal bleeding, transfusions that made her blood type difficult to match; and the fact that antibiotics could no longer address her chronic UTI’s.
That too goes toward cause of death and holds as much weight as an autopsy and medical examiner,” she insists.
“We need as much evidence as you could gather to go up against J&J‘s lawyers. And two hospice referrals with UTIs antibiotic resistant I thought was very important because these are known mesh symptoms.” ~ Mary Dickson
She requested of her two law firms to amend the complaint and when they didn’t Mary asked to be dropped as a client. They agreed. She is proceeding Pro Se, Latin for “on one’s own behalf.”
Judge Joseph Goodwin who is overseeing the multidistrict litigation in Charleston, W.V. has given Mary until December 11th to obtain counsel or provide the court with evidence she is the sole beneficiary and has no creditors.
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Leakage and Bleeding
Six weeks after her first implant, Vada Mae began having problems. She began bleeding, so much so that a doctor recommended a complete hysterectomy.
There was some question that she might have cancer, but no medical record, among the 3,000 pages Mary has collected, reflects that diagnosis and Vada received no treatment for cancer such as chemotherapy or radiation.
The complete hysterectomy, done in January 1972, removed the cervix, ovaries and uterus. Vada was 29 years old.
By the time she was referred to gynecologist Dr. Michael Lassere in 2001, she had started leaking urine. The condition was getting worse. Dr. Lassere used a polypropylene mesh implant, the Ethicon Gynecare TVT-Blue System AA, with an abdominal accessories kit. The kit came with the tools used to implant the mesh.
Mary said she has found no informed consent documents.
Vada was experiencing a lot of pain in her right groin. She was still leaking but now she was losing her balance and falling. Vada developed MRSA in a wound in her right knee from a fall.
An interstim was implanted to tell her when she should pee but, Mary calls it “ridiculous.”
“She was still leaking even between. It wouldn’t vibrate. It (pee) would start rolling out of her.”
Mary says her mother felt aches and pain all over, in her abdomen and pelvic area, up the back of her legs. She had to take her fingers and move her bowel out of the way to urinate because something was blocking the urine flow. She could not have a bowel movement without difficulty.
She was upset and was treated for anxiety and fibromyalgia.
Mary says six months after the TVT was put in, Vada had a distinct odor that you could even smell it outside of her house. Mary believes its’ related to polypropylene, the synthetic polymer that is used to make transvaginal mesh. Her mother was incredibly embarrassed and it wouldn’t go away. You would smell it when she was on the commode, when her legs were apart in the bathroom.
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The Mystery Patient
Dr. Joseph Moshy (Joseph Mouchizadeh) MD, urologist from Lewisburg WV, took over from Dr. Lassere, October 4, 2002.
A February 26, 2005, a record from Dr. Moshy says the patient has a catheter but it is unclear why she is bleeding.
The medical records show Dr Moshy decided to implant a second Ethicon mesh, the TVT-O (Obturator) on September 27, 2006.
The urinary tract infections never cleared up. Urine leakage and falls were a regular occurrence.
By February 2008, Vada was taken to the ER with chest pain, UTI’s and vomiting. Lab tests revealed chronic kidney disease. There was an increase in urine urgency. Back to the ER in October Vada experienced infections, rectal bleeding, urinary tract infections, COPD (she never smoked), gastritis, dizziness, and repeat UTI’s.
Vada Mae had been self-catheterizing to urinate since 2001 and told Mary urination was painful.
In August 2010 she was back in Raleigh General Hospital ER in Beckley WV, with cramping in the pelvic area. She had a kidney bacterial infection and UTI’s. Vada still had incontinence.
Two months later, it was back to the ER with a tear in her bladder and vaginal bleeding. Blood was found in her urine and she had MRSA. The source of the vaginal or rectal bleeding was never found. It never happened at the same time.
Mary says Vada was known as the Mystery Patient by every doctor because they could never find the source for her bleeding.
By August 2011, Vada Mae had been admitted to the ER five times for chronic infections, anemia, falls, UTIs.
Tests revealed her bacterial infections were resistant to multiple antibiotics. She entered a nursing home in November of that year. Vada Mae couldn’t walk or go to the bathroom on her own. She was on hydrocodone and bleeding constantly.
She was on a round of antibiotics and a urinalysis showed greater than 1,000 colonies of gram negative rods. She had grown resistant to Levaquin, Cipro and Bactrin. Dr Moshy said there was no more he could do. He gave her Vitamin c and said there was “no point in intervening on this lady.”
After that, Vada May was admitted to the ER every week until the end of her life.
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An Ad on TV###
An Ad on TVProlene Mesh
In November 2014, Veda Mae saw an ad on television about the symptoms. She wrote it down. Vada told Mary, “I think this might be what’s wrong with me.”
So far, no one had identified the mesh as the culprit behind her ongoing chronic infections or her bleeding.
Mary contacted four law firms and she says every one of them wanted the case. One firm said 40%. That’s too much said Mary. Another wanted 33.3%. Mary went to the first firm and asked if it would match the 33.3%. They would, if it didn’t go to trial.
Mary, and her sister Ruth, went back to Dr. Moshy in early 2015 and said they wanted the mesh removed. He refused because it hadn’t eroded, there was nothing wrong with the mesh, Mary was told, and removal would do more harm than good. The records show,
“Cystoscopy was performed…..…there was a whole mass of papillary type inflammatory change around the trigone and around the ureteric orifices. I was able to see the left ureteric orifice with no difficulty. The right ureteric orifice was extremely difficult to see and covered with heaped up material…I was able to spot weld these areas and managed to control the bleeding.”
A new urologist, Dr. Lohri from Charleston, WV, found unidentified sediment in her bladder.
In a desperate bid to identify her problems doctors diagnosed chronic kidney disease stage 3, (an autopsy found no problem), and Parkinson’s disease (a brain autopsy showed it was normal).
Vada Mae was identified with untreatable sepsis in September 2015. Superbugs they were called. Antibiotics would no longer work on the infections. The hospital could no longer match her blood, Type A+ because it was so altered from transfusions and antibodies, it had become slightly different blood.
A high fever and white blood cell count continued until her death.
ER visits now numbered at least 15 to 20 times a year, Mary says, until the end of Vada’s life.
Vada developed green sores, the same green in her catheter bag, says Mary. By August 2016 she went downhill. Vada wouldn’t wake up or talk. She was completely dehydrated; she wouldn’t drink or eat.
Despite her declining health, Vada knew her daughters. She would light up when they entered the room.
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Cause of DeathWhen Vada Mae died September 13, 2016, she was struggling with a 104 degree temperature and was fighting to breathe. Mary and Ruth asked for morphine but the nursing home was slow to respond. Mary says her mother was suffering at the end.
An autopsy revealed the cause of death was interstitial cystitis, chronic with multidrug resistant bacteria leading to multisystem failure. The bladder was three times its normal size. There were multiple areas of apparent bacterial colonization.
“Dense adhesions make dissection of the pelvic structures difficult, it says. “There is a palpable foreign body present in a dense scar on the anterior surface of the residual vagina.” A dissection found dark blue to brown thin band-like structures of densely and fibrotic tissue.
Mary is still grieving her mother and sister Ruth who died in January 2017 of atherosclerosis. The hospital report shows Ruth had acquired sepsis as well.
“I will give what I have left of my Mom-the untold and dismissed facts and records, of what a Powerful and Trusted Company, J&J has done to millions of women….. My Mom was literally tortured to death, by a 2 cent piece of odor-absorbing and odor-retaining piece of plastic, implanted in her with no turning back.”~ Mary Dickson
Meanwhile, Ethicon set the deposition of implanting physician, Dr. Lassere for November 16, but the case is stayed in an order by Judge Goodwin. He has given Mary Dickson until December 11thto find representation or proceed Pro Se.
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Wave 7Vada Mae Smith’s trial is set for next May 15th along with 150 remaining pelvic mesh cases naming defendant Ethicon, amassed in Wave 7 before Judge Goodwin. The trials will be continuous until all 150 cases in Wave 7 cases are completed.
Vada Mae Smith would have been 75 years old on November 26.
https://www.meshmedicaldevicenewsdesk.com/daughter-fighting-late-mothers-pelvic-mesh-case/
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Nov 24, 2017 | Cambs Times
By Kath Sansom
Sling The Mesh made it to the budget speeches in Parliament this week when MP Emma Hardy spoke of the Government’s short sightedness on the vaginal mesh implant scandal.
Lawyers leading a group action of 500 women, against mesh manufacturers Johnson and Johnson, backed up her plea for a suspension and retrospective audit, saying those with the power to do something are burying their heads in the sand.
David Golten, of Wedlake Bell, said: “It is institutional denial. This cannot go on.”
During her budget speech in Parliament Ms Hardy said women cost the NHS a fortune in pain medication, GP appointments, A&E visits, scans, tests and removals.
Many work reduced hours and claim benefits, which means that in the long term, this cheap quick fix costs much more.
Speaking in the debate in the Commons on Thursday (24), Ms Hardy, MP for Kingston Upon Hull West and Hessle, said: “The short-sightedness of the Government’s continued addiction to austerity is astounding.
“The Government clearly have little understanding of cause and effect.
“Transvaginal mesh has been used to treat stress incontinence on the NHS for 20 years. Prolapse mesh has been used on the NHS since 2002.
“This week, representatives of the All-Party Parliamentary Group on surgical mesh implants met campaigners from Sling the Mesh.
“During the meeting, Kath Sansom illustrated the cost of mesh failure to the NHS.
“Mesh-injured women face the long-term costs of pain medication and removals, but no one has yet realised the extent of the increased health costs because of our fragmented NHS.
“Mesh-injured women are an unplanned extra cost to an NHS budget that is already over stretched.
“Many mesh-injured women suffer chronic pain and urinary infections. Many have leg pain, ranging from moderate to severe.
“Some are in wheelchairs, or using sticks to help them to walk. Risks are serious, they are forever, and they are devastating. Many of these women claim benefits.
“Some work reduced hours and claim working family tax credit, while others receive personal independence payments or other disability benefits.”
• Joanne is an NHS administrator. She costs the NHS £180 a month, and in 11 years her care has cost £55,000.
• Jemima went from being super-fit to sometimes using a stick to walk, and is in daily agonising pain. She has to irrigate her bowel daily using special equipment costing £900 a year in addition to pain medication costing around £135 a month. “Mesh has sliced her insides so badly that she knows that, at some point, her bowel will have to be removed. She is delaying that by using a special kit to pump herself out every day.”
Health minister, Jackie Doyle Price, dismissed calls for a mesh suspension and retrospective audit, during a Westminster Hall debate in October because she said she thought it was more important that women get the treatment.
Ms Doyle Price encouraged everybody to report their cases through the Yellow Card scheme.
Ms Hardy dismissed that response saying: “Most women are not aware of the Yellow Card scheme, and have no idea how to use it.
“We need a retrospective audit on mesh so that the NHS can gather the necessary evidence of the scale of the injuries suffered by those who have had mesh fitted.
“The refusal to fund and commission such an audit is incredibly short-sighted. More women are having this operation every day, and the level of risk is unknown.
“We could be adding astronomical costs to our NHS daily as a result of future mesh failure. However, the costs of mesh failure are not just to the NHS; they are to all our public services.
“Some mesh-injured women need supported housing because of their disabilities. Many of them are suffering from both depression and anxiety, which adds more pressure and demand to our already over stretched mental health services.
“One way the Government could save money for our NHS and our councils would be to fund a retrospective audit for all mesh-injured women. “That would save the costs of treating and caring for them in the future.”
http://www.cambstimes.co.uk/news/vaginal-mesh-sling-the-mesh-wedlake-bell-david-golten-emma-hardy-1-5294456
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Scores of women say top UK surgeon left them with traumatic complications
Nov 24, 2017 | The Guardian
By Hannah Devlin
A group of 100 women are considering legal action against Britain’s most influential pelvic surgeon, claiming that operations he conducted left them with traumatic, life-altering complications.
They claim that Anthony Dixon, a consultant colorectal surgeon at Southmead hospital in Bristol and the private Spire Bristol hospital, was too quick to recommend invasive surgical procedures to deal with pelvic problems.
There are also complaints by several of the women that he made lewd or inappropriate comments about their appearance or sex lives.
Dixon is recognised as a pioneer of surgery aimed at repairing bowel problems, often linked to childbirth. He was founding chair of the Pelvic Floor Society and his reputation is such that patients travelled from across the country and from abroad to seek his help.
But after numerous complaints, the surgeon has been placed under investigation by his local health trust. He has been suspended from work, and the General Medical Council is carrying out a separate “fitness to practise” inquiry.
The Guardian has spoken to eight former patients of Dixon’s. Complaints include:Suffering unmanageable pain or incontinence after elective surgical procedures – risks they say they were not adequately informed about.Needing to undergo further major surgery to help resolve complications they say followed from Dixon’s treatment.Inappropriate remarks made during consultations. One woman, who was in her 20s when she sought treatment, says she was told: “You have the arse of an 80-year-old. I wouldn’t want you dancing in my strip club.”
Another woman said that after her operation Dixon threw some polaroids on to her bed, saying: “There you go, would you like to see your insides?”Dixon said he was unable to comment on specific allegations due to patient confidentiality. He added: “As with any surgical procedure, there may be complications but I would like to reassure patients that the overwhelming majority of operations I have completed have been successful.”
Jean-Jacques de Gorter, group medical director at Spire Healthcare, the private group where Dixon carried out some of his work, said an internal review of the “complications relating to Mr Dixon’s practice” found they were “within normal parameters”.
Several former patients told the Guardian they felt they had been inadequately informed about risks of operations they had signed up for and they ought to have been offered alternative treatments before surgery.
Many of the complaints relate to an operation carried out by Dixon known as a rectopexy, in which a plastic mesh is used to repair weakened pelvic floor tissue.
Sam van der Heijden, 57, from Hastings in East Sussex, asked to be referred to Dixon by her local trust. A difficult childbirth had left her with a damaged rectum, which was causing bowel problems. Dixon recommended surgery and van der Heijden recalled that the main risk she was alerted to was the general anaesthetic.
The operation, in 2011, initially seemed to have worked, but she later underwent a series of revision surgeries, including having her colon removed. She claimed that after one surgery, when she suffered complications, he told her: “I don’t do aftercare,” and: “You’re costing me money. You’re supposed to be out of here in five days.”
Van der Heijden was left with debilitating bowel problems and this month underwent major surgery elsewhere to have her mesh implant removed, spending three days in intensive care to recover.
Rebecca Curzon, 36, had been dealing with unexplained pelvic pain for years before she was referred to see Dixon privately at Spire Bristol in December 2013. She was also given a rectopexy, but after the surgery, Curzon said, she was surprised to read in the operation letter that he had also performed a vaginal repair, which she said had not been discussed.
After the operation, her pain became worse. She said. “I couldn’t go to the toilet at all. I didn’t go for six weeks. I was so ill. I still had the chronic pelvic pain, but now I had rectal pain too.”
Some patients recalled inappropriate remarks during consultation. One woman said he told her she could be sexually promiscuous after he had operated on her.
Several said he had suggested they see a psychiatrist or take antidepressants when they had ongoing pain. One of those was Curzon; in her case she said Dixon had suggested seeing a psychiatrist. “If he thought it was in my head why did he perform such massive surgery on me?” she said.
A woman who was under Dixon’s care for nine years said that after she had had her colon removed, Dixon had asked her if she would like to see a picture of the organ and then texted her a photo showing it, held by a hand in a surgical glove, “like a trophy”.
Some of Dixon’s former patients also underwent a second procedure, called a Starr, which involves using surgical staples in a rectal procedure. The Guardian understands that the GMC investigation was triggered by a complaint from a woman who suffered serious complications after being given the operation as an NHS patient.
Sohier Elneil, a consultant urogynaecologist at University College hospital in London, has, along with colleagues, treated nine of Dixon’s former patients with mesh-related complications. She said some had stated they were not sure why they had had the two procedures, rectopexy and Starr, in the first place. “We’re in a bit of a quandary as to how much information these patients had, based on what they recounted to us,” she said. “Currently you would not be doing that kind of surgery without full discussion.”Advertisement
Andrew Williams, current chair of the Pelvic Floor Society, said Dixon had a reputation for taking on patients with complex problems and was one of the most experienced surgeons in the country at carrying out the rectopexy procedure. He also pointed out that the more operations a surgeon carried out, the more patients with complications they were likely to have. “However fantastic a surgeon you are, surgery is not without complications,” he said. “When and if complications occur they can be really horrible for both the patient and the surgeon.”
Williams added that the best available evidence suggested 60-70% of patients with internal prolapse benefited from the rectopexy procedure, a fraction would see no change or get worse and about 2% would have complications linked to their implant.
The women considering legal action are primarily represented by Thompsons Solicitors and Irwin Mitchell. Madeleine Pinschof, from Thompsons, said most of the women had said they were “in worse pain now than before the surgery and were not adequately warned of the complications that could arise”.
Luke Trevorrow, from Irwin Mitchell, added: “Concerns raised include not having been told of risks and complications prior to surgery, and whether the surgery was appropriate.”
Monica Baird, deputy medical director at North Bristol NHS trust, said it was investigating concerns raised by several patients “regarding certain pelvic floor repair procedures”.
“We would like to reassure patients affected by this that we are doing all we can to investigate their concerns fully,” she said. “We will continue to update patients as more information is available.”
Spire Healthcare added: “Our top priority is always the welfare and safety of our patients.”
https://www.theguardian.com/society/2017/nov/24/women-top-uk-surgeon-traumatic-complications-anthony-dixon
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Surgeon investigated over allegations women suffered 'years of severe pain' after operations
Nov 25, 2017 |
By Henry Vaughan and Catherine Wyatt
A surgeon is under investigation over allegations that women suffered "years of severe pain" after his operations.
Anthony Dixon, a consultant at the private Spire Bristol Hospital as well as the city's Southmead Hospital, is facing a series of complaints from former patients.
The local NHS trust has launched an investigation into concerns over certain rectal floor procedures, which are performed to treat rectal prolapse.READ MOREBig fall in GP numbers as equivalent of 1,000 doctors quit in a yearOne in five EU doctors make plans to leave NHS because of withdrawalHow doctors decide if older patients can cope with an operation
The trust said the surgeon is not currently operating at Southmead and is urging any patients worried about such operations at the hospital to get in touch.
The General Medical Council (GMC) has launched its own fitness to practise inquiry and Mr Dixon is subject to a string of conditions, one of which prevents him carrying out certain procedures.
North Bristol NHS Trust said: "We are investigating concerns that have been raised regarding certain pelvic floor repair procedures which are performed to treat rectal prolapse.
"We can confirm that the surgeon under review is not currently providing any procedures at our hospital.
"We would like to reassure those affected by this that we are doing what's best for patients and we are doing all we can to fully investigate the issues that have been raised."
Emmalene Bushnell, a medical negligence solicitor at law firm Leigh Day, is representing one of Mr Dixon's former patients.
She said: "We are pleased that the NHS trust has launched an investigation into the very serious concerns raised by these women, many of whom have experienced years of severe pain and further surgery.
"It is important that any failings are urgently identified to ensure women will no longer face these types of injuries."
Other women claim Mr Dixon's operations left them with traumatic complications, according to The Guardian, which first reported the allegations.
Mr Dixon told the paper he was unable to comment on specific allegations due to patient confidentiality, adding: "As with any surgical procedure, there may be complications, but I would like to reassure patients that the overwhelming majority of operations I have completed have been successful."
Solicitors Irwin Mitchell have been contacted by more than 50 of Mr Dixon's former patients, although it is not clear how many could pursue a case.
Luke Trevorrow, a medical negligence lawyer at the firm's Bristol office, said they have raised concerns about their treatment under the surgeon's care at Southmead and Spire.
He said the patients had operations including the stapled transanal rectal resection (Starr) - a rectal procedure involving surgical staples - and ventral mesh rectopexy, where mesh is used to repair weakened pelvic floor tissue.
Mr Trevorrow said: "Approximately one third of the patients who have approached us received NHS treatment, but some of the patients who underwent surgery at Spire were NHS patients so it is not possible to provide more accurate numbers at the moment.
"We are in the process of reviewing the concerns that have been raised and cannot comment on individual cases at this stage.
"Concerns raised include not having been told of risks and complications prior to surgery, and whether the surgery was appropriate."
http://www.independent.co.uk/news/uk/home-news/surgeon-anthony-dixon-spire-bristol-hospital-investigation-bristol-nhs-trust-patient-complains-years-a8075731.html
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Mum says she bled every day for almost five years and blames it on a mesh implant
Nov 25, 2017 | Wales Online
By Amy Coles
A mum says her life was ruined after she experienced bleeding every day for nearly five years which she blames on a medical mesh implant.
Catherine Haley, 55, was given the pelvic implant during an operation to remove her womb and fix a prolapsed bowel in 2004.
But she claims she started suffering complications soon afterwards including daily bleeding.
The mum-of-five said: “My youngest started school two months before I prolapsed and from then on it has just been awful.
“It affects your whole life in a way you don’t understand at the time.
“I was scared to go out because I became incontinent.
“I struggle to do anything.”
Catherine was living in Welshpool when she underwent a procedure Royal Shrewsbury Hospital in Shropshire to help secure her bowel which she said involved the use of medical mesh.
But the bleeding began and was so bad Catherine thought she had developed a sterile infection or was suffering an allergic reaction.
In 2005 she had an operation on the medical mesh but it didn’t stop the bleeding.
By 2008 Catherine said she was in “absolute agony” and suffering from ulcerative colitis as her bowel was so inflamed.
She said doctors operated again and found the mesh had disintegrated and turned hard like “glass”.
Catherine said it caused so much internal damage they had to remove her entire bowel and rectum and give her a colostomy bag for life.
She said that up until this point she had no idea her problems were related to the mesh.
She said: “I used to say to my husband it feels like there is glass in my stomach.
“You don’t expect the things they are fixing you with to do this.
“My doctor said he had only taken mesh out of patients twice before and on both occasions they had needed a colostomy bag.
“I spoke to a psychiatrist because the thought of having a colostomy felt like enough to push me over the edge.
“When he did the operation he took the mesh out and found everything had disintegrated.
“It had cut up my insides like glass.”
Catherine now suffers from a series of conditions including irritable bowel syndrome and extreme acid reflux that she said is so bad it has caused lung damage.
She also has three hernias, including one that is “the size of a melon”, and could need further surgery in the future.
Catherine said she is sharing her story to raise awareness about the complications that can resort from medical mesh.
She said: “I have had to grieve for the person I was and the person I would have been.
“Since the mesh, my life has been an existence - not a life.
“They use mesh for so many routine operations. They need to find another way to do these operations without it. It’s not something that is going to go away.”
Catherine said her health problems have impacted on her whole family, including her children who are now aged between 18 and 26, and her five step children.
She said: “My son had just turned five when I had the operation. I was told I could never pick him up again.
“I’ve missed sports days. I can’t go out for long.
“It’s also a physiological thing to have a bag. It wrecked me.”
The couple said they were forced to sell their house and move to a caravan in Aberystwyth as Catherine can’t work and her husband cares for her full time.
They said they are now taking legal action against the Shrewsbury and Telford Hospital NHS Trust who run Royal Shrewsbury hospital.
Dr Edwin Borman, medical director at The Shrewsbury and Telford Hospital NHS Trust, said: “We are sorry to hear that Catherine has concerns about the care she received.
“Whilst we cannot discuss individual cases in detail, I can confirm that we have been contacted about this matter.
“It would be inappropriate to comment further while that process is on-going.”
http://www.walesonline.co.uk/news/wales-news/mum-says-bled-every-day-13950537
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Nov 26, 2017 | The Mirror
By Amy Coles
A mother says she was left in agony and bled every day for almost five years after a mesh implant disintegrated and turned hard like glass.
The complications began for Catherine Haley, 55, soon after she underwent an operation to remove her womb and fix a prolapsed bowel in 2004.
During the procedure she was fitted the pelvic implant, WalesOnline reports.
The mum of five said: “My youngest started school two months before I prolapsed and from then on it has just been awful.
“It affects your whole life in a way you don’t understand at the time.
“I was scared to go out because I became incontinent. I struggle to do anything.”
Catherine was living in Welshpool, Wales, when she underwent a procedure at Royal Shrewsbury Hospital in Shropshire to help secure her bowel, which she said involved the use of medical mesh.
But the bleeding began and was so bad Catherine thought she had developed aN infection or was suffering an allergic reaction.
In 2005 she had an operation on the medical mesh but it didn’t stop the bleeding.
By 2008 Catherine said she was in “absolute agony” and suffering from ulcerative colitis as her bowel was so inflamed.
She said doctors operated again and found the mesh had disintegrated and turned hard like “glass”.
Catherine said it caused so much internal damage they had to remove her entire bowel and rectum and give her a colostomy bag for life.
She said that up until this point she had no idea her problems were related to the mesh.
he said: “I used to say to my husband it feels like there is glass in my stomach.
“You don’t expect the things they are fixing you with to do this.
“My doctor said he had only taken mesh out of patients twice before and on both occasions they had needed a colostomy bag.
“I spoke to a psychiatrist because the thought of having a colostomy felt like enough to push me over the edge.
“When he did the operation he took the mesh out and found everything had disintegrated.
“It had cut up my insides like glass.”
Catherine now suffers from a series of conditions, including IBS and extreme acid reflux that she said is so bad it has caused lung damage.
She also has three hernias, including one that is “the size of a melon”, and could need further surgery in the future.
Catherine said she is sharing her story to raise awareness about the complications that can resort from medical mesh.
She said: “I have had to grieve for the person I was and the person I would have been.
“Since the mesh, my life has been an existence – not a life.
“They use mesh for so many routine operations. They need to find another way to do these operations without it. It’s not something that is going to go away.”
Catherine said her health problems have impacted on her whole family, including her children, who are now aged between 18 and 26, and her five step-children.
She said: “My son had just turned five when I had the operation. I was told I could never pick him up again.
“I’ve missed sports days. I can’t go out for long.
“It’s also a physiological thing to have a bag. It wrecked me.”
The couple said they were forced to sell their house and move to a caravan in Aberystwyth, as Catherine can’t work and her husband cares for her full time.
They said they are now taking legal action against the Shrewsbury and Telford Hospital NHS Trust, which runs Royal Shrewsbury Hospital.
Dr Edwin Borman, medical director at The Shrewsbury and Telford Hospital NHS Trust, said: “We are sorry to hear that Catherine has concerns about the care she received.
“Whilst we cannot discuss individual cases in detail, I can confirm that we have been contacted about this matter.
“It would be inappropriate to comment further while that process is ongoing.”
http://www.mirror.co.uk/news/uk-news/it-cut-up-insides-like-11590484
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'It's just soul destroying': when pelvic surgery goes wrong
Nov 24, 2017 | The Guardian
By Hannah Devlin
“Nobody wants to talk about toilet function at the best of times,” says Jacqui Shaw. “It’s just one of those topics people, especially ladies, want to keep to themselves.”
But after two operations for bowel problems left her with permanent and debilitating complications, she has decided to speak out.
Shaw, 50, had difficult deliveries with both her children, in 1992 and 1996, each time requiring ventouse. As a result of internal damage, she was having trouble going to the toilet and eventually went to see a local doctor in Newcastle-under-Lyme.
He told her he knew of a Bristol-based surgeon, Anthony Dixon, with an international reputation for pelvic repair. “I thought I’d struck gold,” she said. “I thought: ‘I’m so lucky I’ve got this insurance that covers me.’”Guardian Today: the headlines, the analysis, the debate - sent direct to you
Read more
Shaw travelled to Bristol and Dixon recommended a procedure known as a rectopexy, in which a mesh would be inserted to support the tissue around her rectum. She recalls him reassuring her that he had performed the same operation on a family member. “That made me think … you must be quite confident, it must be really good,” she said.
After the operation at the Spire Bristol hospital, Dixon visited her in recovery, told her that everything had gone well and then, she said, threw some polaroids on to her bed, saying: “There you go, would you like to see your insides?”
“He also said: ‘It’s a shame you didn’t see me earlier as you wouldn’t have needed [a] hysterectomy if you’d come to see me first,” she said. “For all he knew I might have wanted more children. It was just a bit odd.”
The surgery was unsuccessful: it hadn’t resolved her bowel problem and she was now also experiencing severe pain. When she contacted Dixon he suggested further surgery, a Starr procedure, which she said was portrayed to her as “a tweak” to the surgery she had already had.
“I thought: ‘I don’t want another operation. I have two children,’” she said, but added that she felt she had no choice, having come this far.
She describes the operation, in 2009, as “horrific” and far more invasive than she had been prepared for. “There’s nothing written on my notes about complications or anything,” she said.
“When I came home, I had the feeling of being in the middle of passing a motion,” she said. “The pleasure-pain-type funny feeling. I had that constantly, 24/7, for weeks and weeks.”
During the years that followed, she has continued to have pain as well as a “pulling sensation” in her tummy and feelings of numbness that prompted doctors to test her for MS and stroke. And her bowel issues were never fully resolved.
Eventually, she sought the advice of a gynaecologist who concluded that the original rectopexy mesh was at least partly to blame. A year ago, Shaw had most of the mesh removed – although some was embedded in her bowel and bladder and could not be extracted. Her surgical notes state that the implant had “rolled up on itself creating almost … a rod of tissue”. The removal relieved the “pulling” feeling, but she still suffers ongoing pain.
Shaw says her husband has been “brilliantly” supportive, but she considers herself lucky to have a marriage strong enough to have survived. “The lack of a physical relationship, emotionally that’s really difficult and some blokes wouldn’t put up with that,” she said. Her health problems mean she often has to take time off work at short notice, and she says she has only been able to carry on working because she runs a family business.
Reflecting on her experience, Shaw says she is angry that she does not feel she was fully informed of known complications of the surgeries she underwent. She believes that procedures such as the Starr should be, if there is a place for them, the “very last port of call”. And she says she has found it very difficult to trust others since her experience of complications after being treated by Dixon. “It’s just soul-destroying. It messes your head up something crazy,” she says.
https://www.theguardian.com/society/2017/nov/24/soul-destroying-when-pelvic-surgery-goes-wrong
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