Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, March 14, 2017

Australian Pelvic Surgical Mesh Scandal Widens

Difficulty issues remain about mesh surgery for women.


13 Mar 2016, 4 p.m.
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.

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 withdrawing 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.

No comments:

Post a Comment