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.
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Thursday, March 16, 2017

By Lucy Adams FiDA highlight
Political correspondent, BBC Scotland
  • March 15, 2017

An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned.
The consultant, who does not wish to be named, stepped down following the revelation that an entire chapter of the final report had been removed.
It follows the resignation of two patient representatives who claimed the report had been watered down.
Health Secretary Shona Robison said no evidence would be hidden.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014 former health secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.


Patients representatives Olive McIlroy and Elaine Holmes have already resigned from the review group
An interim report published in October 2015 did not advocate a blanket ban on mesh implants but noted that some women do experience serious complications and it made suggestions for reducing the risks. The final report is expected shortly.
Earlier this month, the BBC revealed that an expert member of the review group had written to its chairwoman, raising concerns about the final draft.
The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
Patients representatives Olive McIlroy and Elaine Holmes, who have both suffered complications as a result of such surgery, resigned from the review earlier this month, claiming that the final report now lacked integrity and independence.


Responding to the latest resignation, Health Secretary Shona Robison said clinical experts sometimes disagreed on complex medical matters.
She said: "I want to reassure the Scottish Mesh Survivors Group their views have been heard, and I want them to remain at the centre of the crucial work.
"I have been clear that all evidence must be made publicly available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.
"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."
Ms Robision is due to meet Olive McIlroy and Elaine Holmes later this week to discuss their concerns.
In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.
Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.

http://www.bbc.com/news/uk-scotland-39279028?SThisFB

Wednesday, March 15, 2017

Pelvic Surgical Mesh Scandal: FDA Wrongly Cleared Predicate Device



Dr Peter Petros said he warned women about the 'very frightening' symptoms of his procedure 

Joanne McCarthy  FiDA highlight

15 Mar 2017, 5 a.m.
A DOCTOR whose invention is at the centre of a global medical scandal told a court in 2004 that women could experience “very frightening” symptoms after a pelvic surgical procedure he developed, but that was “how the operation works”.

“Even though it’s not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it,” Dr Peter Petros told a Western Australian court after a woman took civil action against him following mesh surgery using nylon tape.

Judge Roger Macknay awarded the woman more than $136,000 after finding Dr Petros “undoubtedly” failed to warn her of risks associated with Dr Petros’s intravaginal slingplasty (IVS) procedure, based on his “integral theory” to treat urinary incontinence.

The woman, 45 when she had the surgery in 1997, suffered “significant” injury which had a “substantial” effect on her life, with symptoms continuing over the long term, Judge Macknay found.

Dr Petros’s mesh delivery device through a woman’s vagina, the IVS tunneller, which was later developed by a subsidiary of Tyco Healthcare and incorrectly cleared for use in America in 2001 for both urinary incontinence and prolapse in women after childbirth, became the “predicate case” which major medical device companies used to “clear” and market multiple other pelvic mesh devices for prolapse.


Investigation: Dr Peter Petros

Global legal cases brought by women alleging serious injuries after pelvic mesh surgery are estimated to cost $20 billion.

In a paper in 2012 Dr Petros distanced himself from the global mesh scandal, saying his “early experimental studies” had been “wrongly” used as “an intellectual cornerstone to justify the use of mesh in prolapse surgery”.

During the 2004 Western Australian court case Dr Petros denied being “somewhat blinded” to possible risks associated with his (IVS) surgical procedure.

“Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it? You see it as your baby and you can’t see any bad elements?” the woman’s barrister, Geoffrey Hancy, put to Dr Petros.

Dr Petros replied: “Absolutely not. The role of the scientist is to seek the truth, whether it’s good or bad. That’s the way it is.”


The court was told Dr Petros received a royalty of about $15 per instrument for the IVS tunneller and he performed about 400 operations a year. 

Judge Macknay found Dr Petros had “a proprietary attitude towards the IVS procedure, as well as great pride in events associated with its development”.

In his dealings with the woman Dr Petros “was concerned to extol what he perceived to be the many advantages of the IVS procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and the risks”.

“The defendant did not, it would seem, and apparently still does not, believe there was or is any real detriment associated with ‘his’ procedure,” Judge Macknay said.

Dr Petros “lacked to some extent a complete understanding of the obligation owed by a medical practitioner to a patient who was contemplating surgery”, and was “at times argumentative, anxious to debate, unwilling to answer questions as put, anxious to display his knowledge”, the judge found.

Specialists who gave evidence said the IVS procedure had no independent studies to support it in 1997 and the majority of specialists who performed surgery to treat incontinence did not use the procedure.

By 2003 Newcastle obstetrician/gynaecologist Dr Alan Hewson and his Brisbane colleague Dr Chris Maher said the IVS procedure “cannot be recommended” after treating women dealing with complications after its use, and because of the lack of independent evidence of its safety and efficacy.    

Dr Petros’s name no longer appears on the Australian Health Practitioner Regulation Agency register. He did not respond to questions from the Newcastle Herald about whether he had retired in November. 

The NSW Health Care Complaints Commission advised the Herald it has finalised an investigation of complaints against him and has referred the case to “the Director of Proceedings for the consideration of appropriate disciplinary action”.

http://www.theherald.com.au/story/4524242/doctor-denies-being-blind-to-mesh-risk/?cs=305






Tuesday, March 14, 2017

Australian Pelvic Surgical Mesh Scandal Widens




Difficulty issues remain about mesh surgery for women.

JOANNE McCARTHY  FiDA Highlight

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.
http://www.theherald.com.au/story/3778936/women-pay-the-price-for-a-most-private-medical-disaster/
http://bit.ly/2nC4LQF

Friday, March 10, 2017

4/27/2017 ACTION: Johnson & Johnson Annual Shareholders Meeting











Who: Device and Drug Harmed Patients/Advocates:  

Pelvic Surgical Mesh, Breast Implants, Hernia Mesh, Power Morcellators, Hip Replacements  Risperdal, Levaquin,  Motrin, etc.

What: MAM Rally & Patient Safety Peaceful Protest with Award-winning Documentary Filmmaker
When:  Thursday, April 27th 2017, 8 am - 1pm EDT
Where:

State Theatre
15 Livingston Avenue
New Brunswick, NJ 08901

J&J Headquarters
1 Johnson and Johnson Plaza (Intersection of Albany & Neilson)
New Brunswick, NJ  08901-1241

RSVP to organizers on the official Facebook Event Page:  https://www.facebook.com/events/1190677214382644/

Meet & Greet
Wednesday Evening, April 26th, 6pm
Carrabba's Italian Grill
335 NJ-18, East Brunswick, NJ 08816
(732) 432-8054


Video of 2014 action:  

https://vimeo.com/92990332

What the shareholders are told: http://www.investor.jnj.com/events.cfm

$1Billion verdict J&J DePuy Pinnacle metal-on-metal hips (December 2016)
https://www.law360.com/articles/867121/3rd-j-j-hip-implant-bellwether-delivers-1b-verdict
$2 Billion settlement - Risperdal (2013)
http://articles.latimes.com/2013/nov/04/science/la-sci-drugmaker-settlement-antipsychotic-20131104
Levaquin antibiotic  http://www.fiercepharma.com/regulatory/levaquin-users-slap-j-j-800m-rico-suit-claiming-pharma-giant-hid-serious-side-effects
https://www.drugwatch.com/manufacturer/johnson-and-johnson/

Research must be carried on, innovative programs developed and mistakes paid for. 
The Johnson & Johnson credo

Hotel:  
Holiday Inn Express & Suites Tower Center New Brunswick
4 Tower Center Blvd
East Brunswick, New Jersey 08816

800-315-2621 or 732.247.6800
www.ihg.com/holidayinnexpress/hotels/us/en/east-brunswick/ebknj/hoteldetail

$99 discount rate - code: MAM(complimentary breakfast is included)


Airport:  

Newark (airport code EWR)
20 miles from hotel
or
LGA(LaGuardia airport) via hired car to NYC Penn Station/Manhattan to NJTransit/New Brunswick Station $14/1 hour

Contributions:

Encourage your supporters to participate financially:
GoFundMe to help with expenses and to help pay for hotel costs for those in need.  
https://www.gofundme.com/jj-mesh-rally-fund