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Mesh scandal: Scots campaigners vow to fight on as US firm close implant business after £1bn legal costs
Mar 13, 2016 | Scottish Daily Record & Sunday Mail
By Marion Scott
ONE of the world’s biggest mesh manufacturers are closing down their implant business after legal costs soared to more than £1billion. -
Difficulty issues remain about mesh surgery for women
Mar 13, 2016 | Newcastle Herald
By Joanne McCarthy
THE woman on the end of the phone line said hello and gave her name, and then the sobbing started. For at least a minute she tried to talk but the sobbing overwhelmed her. She regained some control and apologised: “I’m sorry, I’m so sorry, I’ve just had no one to talk to”. -
Medical mesh concerns raised
Mar 12, 2016 | Newcastle Herald
By Joanne McCarthy
...In April last year – and after tens of thousands of American women had launched lawsuits against mesh device manufacturers, and hundreds more in Australia were in a class action against mesh manufacturer Johnson & Johnson - Carol Proper of Ohio became the first American woman to launch civil action against TFS Manufacturing and the Texas-based arm TFS Surgical. -
Weekend Doctor
Mar 13, 2016 | The Courier
By Dr. Miguel Jordan
...In more severe and long-term cases of urinary incontinence, surgery may be necessary. One surgical option for stress urinary incontinence treatment is a mesh sling procedure.
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Mar 13, 2016 | Scottish Daily Record & Sunday Mail
By Marion Scott
ONE of the world’s biggest mesh manufacturers are closing down their implant business after legal costs soared to more than £1billion.
Endo, who make three mesh devices used in Scottish hospitals, will cease production and stop selling the products by the end of the month.
Spiralling legal fees and the huge payouts awarded by juries to injured women in the US have severely dented the firm.
Experts predict Endo won’t be the only mesh producer to stop production as manufacturers face being sued by women from around the world .
Almost 140,000 cases are under way in the States alone. Endo have shared the position as the biggest supplier of mesh devices with Johnson & Johnson-owned firm Ethicon.
Bosses insist the implants, used to treat pelvic organ prolapse and incontinence, are safe – despite announcing they will no longer be available through their Astora division.
Endo’s Heather Zoumas-Lubeski said: “After a comprehensive review of the strategic business options, and particularly given the continuing legal disruptions associated with the vaginal mesh business, we have now determined the best strategy is to wind down this business.
“This decision does not change our consistent position, supported by robust clinical data and FDA clearances, that Astora’s products are safe and effective and have restored the quality of life for countless women suffering from the debilitating conditions of incontinence and pelvic organ prolapse.”
The Scottish Government ordered an independent review into the use of mesh implants last year after a long-running Sunday Mail campaign.
The use of the three devices made by Endo was suspended pending the outcome of the
investigation. Holyrood made the move following a wave of complaints from women who claimed they had been left with life-changing injuries following the controversial treatment.Elaine Holmes, of campaign group Scottish Mesh Survivors, said: “We’re delighted Endo are stopping production and yearn for the day all mesh firms follow suit”.
American Medical Systems were bought by Endo in 2011 for £2billion. In June 2013, AMS agreed payouts of £40million and a further £700million in 2014, with 16,000 cases pending.
In the past two years, Johnson & Johnson have spent more than £1billion on litigation costs and are facing upwards of 42,000 mesh claims.
They were ordered to pay Teresa Taylor £3million by a Georgia court last month.
Their Ethicon division were also ordered last month to pay Sharon Carlino, 52, from New Jersey, £11million after she claimed the most-used mesh device in Scotland, the TVT, caused injury.
Walmart shelf stacker Patricia Hammons, 65, was awarded £10million including substantial punitive damages in December by a Philadelphia court .
US attorney Adam Slater, who has won millions for victims and gave evidence to the Scottish Parliament’s mesh review, said: “Endo’s decision to stop marketing pelvic mesh was inevitable. In my opinion, all manufacturers will eventually stop selling these insidious devices proven incompatible with permanent implantation in the female pelvis.”
More than 400 mesh victims will be heard at the Court of Session in Scotland’s biggest medical claim.
Lawyer Cameron Fyfe said: “We’d hope the wealth of evidence emerging across the world adequately shows many mesh implants have not only been found defective, juries believe they are responsible for causing extensive injuries and have reflected that in the high level of settlements.
“Although that high level of settlements couldn’t be achieved in the UK, we’d hope that, rather than drag ill and injured women through harrowing court procedures, mesh companies will consider
settling claims here too.” -
Difficulty issues remain about mesh surgery for women
Mar 13, 2016 | Newcastle Herald
By Joanne McCarthy
THE woman on the end of the phone line said hello and gave her name, and then the sobbing started. For at least a minute she tried to talk but the sobbing overwhelmed her. She regained some control and apologised: “I’m sorry, I’m so sorry, I’ve just had no one to talk to”.
Then the sobbing resumed as she gasped: “I’m rotting from the inside.”
The woman is in her 50s. In 2012 she had surgery to treat prolapse – where a woman’s uterus bulges into the vagina, typically after pregnancy – and her gynaecologist, who has worked in the Hunter, the Central Coast, Sydney and other parts of NSW, spoke about the benefits of using mesh as an internal sling to pull her organs back into place.
He recommended “natural” mesh made of pig intestines, and surgery through the vagina rather than the abdomen.
In a paper for other doctors in 2007 the gynaecologist praised the “natural” mesh over earlier biological prolapse treatments which, he said, women’s immune systems came to regard as “dead tissue” subject to “a strong foreign body reaction”.
In the 2007 paper the doctor declared a conflict of interest – he was being funded by the pig intestine mesh manufacturer to conduct a trial of the mesh’s use in women’s bodies.
The woman said she knew nothing of that.
The pain after surgery started immediately. It worsened with time. Then the “horrible smell” started, the rounds of antibiotics to treat infections, and comments from the gynaecologist that it was “just the healing process”.
After nine months she had a nervous breakdown.See your ad here
In chronic pain, unable to have sex, isolated, emotionally shattered and coming to terms with the shocking knowledge there was little surgically that could be done to relieve the pain or remove the mesh, she hinted at suicidal thoughts.
“I felt like I was treated like a guinea pig,” she said, and sobbed.
“Why is this allowed to happen?”
It only made it worse to hear there are many other women like her.
What has become a global mesh catastrophe for possibly more than 100,000 women who sought prolapse treatment over a decade – which could become one of the biggest medico-legal cases in history - started with a United States Food and Drug Administration (FDA) decision in 2001.
The FDA approved a prolapse mesh device for surgery through a woman’s vagina based on it being “substantially equivalent” to an existing device for surgical incontinence treatment.
Any differences between the devices “do not raise new questions of safety and efficacy”, the FDA stated, so a new prolapse mesh kit device was approved without the rigorous pre-market testing required of new devices or Class III high risk devices.
The decision, which provided a treatment option for gynaecologists in a difficult area where up to 50 per cent of women seek help for prolapse and incontinence problems over their lifetimes, and up to 19 per cent of American women receive surgical treatment, opened a door and manufacturers responded.
Within a few years up to 40 companies had more than 60 surgical mesh kits for prolapse patients on the American market stating they were “substantially equivalent” to other mesh products, and all reliant on the 2001 FDA approval. They included biological or “natural” mesh products as well as polypropylene plastic devices for vaginal access, or transvaginal, surgery.
By 2012 there were 47 prolapse and incontinence devices on the Australian market.
The only problem was the FDA’s decision process was flawed, said leading Australian urogynaecologist and Queensland University Associate Professor Chris Maher in a paper in 2013 headed The Transvaginal Mesh Decade.
The device approved in 2001 was subject to high complication and infection rates when used to treat prolapse, and was modified and gained a new clearance seven years later.
But the genie was out of the bottle.
The first mesh kits with tools to insert the mesh through incisions in a woman’s vagina were on the market in America in 2004. By 2010 more than 300,000 mesh kits a year were being used for prolapse surgery.
But by that stage adverse event reports were also being logged, with a five-fold increase in adverse reports to the FDA between 2005-2007 and 2008-2010.
The adverse events included mesh erosion and extrusion into the vagina and urinary tract, bleeding and infections, organ perforation, severe and chronic pain, nerve entrapment and urinary problems.
By 2013 a Newcastle specialist complained to the Australian Therapeutic Goods Administration (TGA) about the lack of “rigorous constraints” controlling new medical devices, when compared to drugs, after a woman nearly died of excessive blood loss linked to mesh implant surgery.
The specialist warned the TGA an approved suture device was unsafe after a woman suffered a severe haemorrhage during a trial. The woman complained to the Health Care Complaints Commission about the specialist, saying the operation “went dramatically wrong”.
In his paper Associate Professor Maher outlined how mesh devices remained on the market for a decade, with sometimes catastrophic results for many women.
“These products were aggressively marketed to clinicians by the manufacturers on the basis of FDA clearance,” he said.
Manufacturers, and not Australian, British and American colleges of obstetrics and gynaecology, trained doctors to use the new mesh products to treat prolapse.
It was not until 2011, after thousands of adverse event reports and the start of serious litigation by patients, that the FDA determined serious adverse events with mesh were “not rare”, and could be “life-altering” for some women.
In October 2012 the Australian TGA website noted it had only received 63 adverse event notices, the majority from device manufacturers, despite many thousands of devices being implanted.
The TGA met with the Urogynaecological Society of Australia where the society reinforced its view “the issues were about the use of these meshes rather than the meshes themselves”.
In his paper Associate Professor Maher noted at least three members of an international gynaecological association that commented about prolapse mesh devices after the 2011 FDA statement received royalties from device manufacturers.
By January 2014 the FDA warned manufacturers it proposed to upgrade mesh products for vaginal-entry prolapse surgery to Class III high risk category, requiring manufacturers to provide clinical data supporting device safety, and post-surgical data demonstrating safety and efficacy.
But by that stage civil suits in the US – and the threat of many more to come – coincided with manufacturers withdrawdrawing devices from the market.
In a significant case American woman Linda Gross was awarded $11.1 million against Johnson & Johnson after prolapse mesh surgery in February 2013 led to 18 subsequent operations. An appeal by the company is currently being heard in the New Jersey Appeals Court.
Mesh activist Jane Akre said more than 100,000 women had filed lawsuits against companies, with Philadelphia woman Patricia Hammons, 65, the most recent successful mesh device plaintiff who was awarded $12.5 million against a Johnson & Johnson subsidiary in December.
Akre said device manufacturers, doctors and regulators had catastrophically failed many women.
Devices entering the market without the clinical assessment required for drugs meant “patients became the post-market clinical trial subjects and many suffered devastating and permanent injuries”.
“The woman at the other end of the pelvis was not even thought of,” Akre said.
Transvaginal mesh legal suits are expected to reach more than $20 billion.
In an internationally-respected Cochrane Review of studies of mesh devices in February, Associate Professor Maher found the quality of evidence ranged from very low to moderate.
In a Cochrane editorial in February titled No implementation without evaluation: the case of mesh in vaginal prolapse surgery, University of Auckland Professor of Obstetrics and Gynaecology Cindy Farquhar said the transvaginal mesh decade was a warning to doctors who had to “learn from the lessons of the mesh experience”.
“New interventions should always be subject to rigorous evaluation through randomised controlled trials, and adoption of new interventions must be accompanied by specific training in their use. Future studies should report adverse events carefully and include reporting pain and quality of life. Our patients deserve better studies and, in the absence of evidence, better advice.”
Port Stephens MP, health lawyer and member of NSW Parliament’s committee on the Health Care Complaints Commission, Kate Washington, said the mesh debacle was consistent with “the dismissive nature of the medical fraternity to women who’ve had significant injury following birth”, including many who suffered with prolapse.
“This dismissive attitude to what are really serious problems for women is really embedded in the medical profession.”
The low number of formal complaints from women to Australia’s Therapeutic Goods Administration about mesh devices was not surprising, she said.
“This is a hidden issue. The women involved are vulnerable, embarrassed and mortified by what’s happened to them in terms of the injuries they’ve sustained, and the fact that it’s hidden has allowed practices like this to flourish.”
Associate Professor Maher said while regulators in Australia and America had failed to monitor and influence clinician behaviour relating to transvaginal mesh, litigation lawyers and publicity had brought about change.
“This scenario is completely unsatisfactory for all pelvic floor clinicians who have failed to demand a satisfactory level of evidence regarding the safety and efficacy of a product prior to its utilization,” he said.
“It is vital that we review the events that allowed the women we are trained to serve to be exposed to unknown risk during the surgical treatment of prolapse.”
In 2012 in response to rising concerns about mesh the Australian TGA said it was not possible to know “all the possible complications that may develop” when a new medical device is approved for use.
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Mar 12, 2016 | Newcastle Herald
By Joanne McCarthy
THE Australian Therapeutic Goods Administration (TGA) has a database where the public can view adverse reports made about medical devices since 2012.
Because an adverse outcome might be the fault of a device, or the surgeon, or a combination of the two, or neither, the Database of Adverse Event Notifications carries a warning.
“Please do not make an assessment about the safety of a medical device based on the information in the database,” it says.
Six adverse reports appear on the database if you type in the words “TFS Manufacturing”, which produces the Tissue Fixation System transvaginal mesh prolapse device.
The device was developed by Dr Peter Petros who was sole director of TFS Manufacturing from May 2004. It was approved in Australia in October 2004, registered in 2006, and cleared for sale in America from May 2005. In July 2009 Dr Petros resigned as director and former Newcastle Falcon basketballer and Australian representative player Paul Zadow became sole director.
The TFS medical device, in the hands of skilled surgeons, brings enormous benefit to many women ...- TFS director Paul Zadow
Two of the adverse TGA reports were sent by patients, and four by health professionals.
The surgeon who carried out the procedures, Dr Richard Reid, is the subject of a Health Care Complaints Commission investigation. He is prohibited from carrying out major surgery after the NSW Medical Council suspended him in 2014, and placed conditions on his practice after he successfully appealed and was reinstated.
Dr Petros is also the subject of a Health Care Complaints Commission investigation.
The adverse reports for the TFS Manufacturing device, recorded between January and October 2014, note the following: “Severe complications and ongoing medical issues including multiple surgeries following insertion of TFS system”; “Nerve entrapment, mesh pain syndrome, pelvic floor muscle spasm”; “This patient has chronic pain after TFS insertion. The implant was inserted unusually high, with anchors possibly impinging on the pudendal nerve or its branches. The patient has chronic pelvic/ back/ leg pain after TFS insertion, and prolapse recurrence”.
The adverse events continue: “One of the implants was placed unusually high, likely close to the pudendal nerve and/ or its branches. Chronic pain syndrome after placement of TFS tapes”; “Multiple devices used for incontinence and prolapse surgery. Several attempts by implanting surgeon at removing parts or all of these implants later due to multiple complications”.
TFS Manufacturing was one of the first companies to have its mesh device deregistered by the TGA in November 2014 after the TGA responded to rising concerns about all transvaginal mesh devices on the Australian market.
It deregistered the TFS device after deciding the company had failed to substantiate how it complied with relevant standards. TFS Manufacturing’s appeal to the Administrative Appeals Tribunal is ongoing.
In a statement on Thursday Zadow said his company “maintains that the TFS medical device, in the hands of skilled surgeons, brings enormous benefit to many women in Australia and around the world”.
The withdrawal of the device from the American market in August 2015 was a commercial decision and “was not based on any safety or regulatory issues”, he said.
In January this year the US Food and Drug Administration reported only five mesh devices remained on the market, from a high of more than 60 in 2011.
In April last year – and after tens of thousands of American women had launched lawsuits against mesh device manufacturers, and hundreds more in Australia were in a class action against mesh manufacturer Johnson & Johnson - Carol Proper of Ohio became the first American woman to launch civil action against TFS Manufacturing and the Texas-based arm TFS Surgical.
In a Cuyahoga County Court of Common Pleas complaint she alleged she had been “injured catastrophically” after mesh surgery using TFS in August 2013, and that Sydney-based Dr Peter Petros, who developed TFS, “supervised” her surgery. Dr Petros did not respond to a Herald request for comment and TFS Surgical denied Dr Petros “supervised”.
Proper alleged she was not appropriately advised of the “experimental nature of this procedure, and that there were safer treatment alternatives”, was not appropriately warned of the risks, and underwent surgery two days after her operation to remove the TFS sling and all but one of the anchors securing the mesh to her body because of pain and infection.
She alleged defendants TFS Manufacturing, and the Texas-based firm TFS Surgical (US) Inc, took part in “aggressive” marketing to health care providers, doctors and directly to the public, offering “exaggerated and misleading expectations” of the product’s safety.
Proper also alleged TFS, through its physician training program, “provided physicians with the comfort that they had sufficient training to minimize or eliminate adverse effects resulting from the devices”.
In its response to the complaint TFS Surgical denied the device was defective, or the existence of “safer treatment alternatives”.
The company admitted marketing the product to health care professionals, but denied “aggressive marketing” at medical conferences, hospitals, or private offices.
It admitted running a website, but denied it was “direct to consumer advertising” or part of a “multifaceted marketing campaign”. The company also denied “offering exaggerated and misleading expectations” about the device’s safety and utility.
In his statement on Thursday Zadow confirmed that TFS Manufacturing and TFS Surgical were subject to an ongoing legal claim in America initiated by Proper.
”TFS strongly refutes Mrs Proper’s claim, and is defending the claim. TFS denies that it is the cause of any issues suffered by Mrs Proper,” he said.
An Australian Register of Therapeutic Goods (ARTG) public summary of TFS Manufacturing’s registration of the TFS mesh device on October 30, 2006, says the device’s intended purpose is “the placement of synthetic mesh tape to cure female urinary or faecal incontinence and vaginal prolapse”.
The company’s use of the word “cure” in the ARTG application was the subject of a complaint to the TGA from a patient advocate in August 2014.
“By listing the intended purpose of the device as a ‘cure’ in the ARTG register, this is a statement to the public that the product is validly registered and accepted with that purpose,” the complaint said.
“This ARTG registration also suggests there is accepted scientific evidence which supports this claim of a cure.”
The ARTG public summary showed a registration application was made on October 13, 2006 and approved 12 working days later.
The TGA has not responded to a Newcastle Herald request for information about the process used by it to approve the device, or the scientific evidence relied on to register it for use on the Australian market.
In a paper in 2012 Dr Petros, who developed the Tissue Fixation System prolapse device based on his 1990s “integral theory”, described the mesh implant field for prolapse surgery as “a free for all”.
“See one, do one, teach one,” he said, in a paper describing “serious problems” with early mesh devices including “bladder perforation, injury to major blood vessels, nerves, small bowel and large haematomas”.
In a 2004 damages case Dr Petros was criticised by a West Australian district court judge for failing to warn a woman his “integral theory” to treat urinary incontinence and prolapse was “not a standard procedure… and was not employed by a majority of gynaecologists”.
The judge found Dr Petros lacked “a complete understanding of the obligation owed by a medical practitioner to a patient” before awarding a woman more than $136,000 in damages.
Dr Petros was “more concerned to extol what he perceived to be the many advantages of [his] procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and risks”.
In July 2014 the American TFS Surgical website said the “integral theory set the foundation for a new approach” to female pelvic floor dysfunction and its Tissue Fixation System was “in keeping with this theory”.
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Mar 13, 2016 | The Courier
By Dr. Miguel Jordan
If running, lifting, coughing, laughing or sneezing causes you to unintentionally and unexpectedly lose small amounts of urine, you may have urinary stress incontinence.
Stress incontinence is especially common in women who have had more than one pregnancy through vaginal delivery. The condition is typically caused by physical changes in the body such as pregnancy and childbirth, menstruation, menopause, surgery, and/or weakened bladder muscles.
If you have this, you’re not alone. The annual direct cost of urinary incontinence in the United States was estimated as $16.3 billion in 1995.
Stress urinary incontinence can be a very uncomfortable and inconvenient health issue. While some women may believe that accidental urine leakage is bound to happen as they get older, the truth is that the problem can be minimized with the right self-help techniques and treatment.
Kegels are pelvic muscle training exercises that can be done at any time. To do Kegel exercises, squeeze the sphincter muscles as if you are trying to stop the flow of urine. While contracting these muscles, try not to move your legs, buttocks or abdominal muscles.
If you are doing the exercises correctly, no one should be able to tell that you are doing Kegels. They help strengthen the muscles that support the bladder, uterus and bowels, which can help prevent urinary leakage.
In addition, women can change certain behaviors that may increase their risk of stress urinary incontinence. Examples include:
• Urinating more frequently to reduce the amount of urinary leakage;
• Avoiding drinking alcohol or caffeinated beverages, which stimulate the bladder;
• Losing weight, if you are overweight;
• Quitting smoking, which can reduce coughing, bladder irritation and the risk of bladder cancer;
• And avoiding foods that can irritate the bladder, such as citrus fruits and spicy foods.
If you are a woman and you are unable to control stress urinary incontinence with these behavior changes, medication or other procedures may be able to improve symptoms. Treatment options include biofeedback, pessaries and even surgery, in some cases.
Biofeedback takes information happening in the body and displays the information in ways that are easy for individuals to understand.
Biofeedback can be effective in treating urinary incontinence by showing women the muscles they are training when they do Kegel exercises. By placing a few sensors on areas of the lower body and doing Kegel exercises, biofeedback can display a women’s pelvic muscle strength through computer graphs and audible tones.
Being able to see, hear and understand the pelvic muscle activity may help individualize and improve a woman’s Kegel exercises, which can help prevent urinary leakage.
Medical devices such as pessaries can also help women manage urinary incontinence. A pessary is a small ring or disk that is inserted into the vagina. The device is typically made of silicone or latex and can be worn all day.
A pessary is prescribed, fitted and inserted by a doctor, and helps support the bladder to prevent urine leakage.
In more severe and long-term cases of urinary incontinence, surgery may be necessary. One surgical option for stress urinary incontinence treatment is a mesh sling procedure.
In this type of surgery, strips of mesh are used to create a sling beneath the neck of the bladder and the urethra, the tube that carries urine. This helps keep the urethra closed when women cough, laugh or sneeze.
The Burch procedure, considered the gold standard, is a mesh-free technique and can be done openly or robotically to return support of the urethral vesicle angle, or neck of the bladder. Both procedures typically have low complication risks and high rates of effectiveness in treating urinary incontinence.
Talk to your doctor if you are concerned about female stress urinary incontinence.
Jordan is an OBGYN with Blanchard Valley Women & Children’s Center, Findlay. Questions for Blanchard Valley Health System experts may be sent to Weekend Doctor, The Courier, P.O. Box 609, Findlay, OH 45839.
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