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Ethicon Media Monitoring 3/15/2017
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Pelvic mesh victim in the dark about mesh implant for nearly a decade
Mar 15, 2017 | Newcastle Herald
By Joanne McCarthy
LYNDA Garlinge spent nearly 10 years dealing with severe and disabling complications after surgery for incontinence in 2004, without knowing she had been implanted with mesh. -
'I warned women about the 'very frightening' symptoms', says Dr Peter Petros
Mar 15, 2017 | The Daily Advertiser
By Joanne McCarthy
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”. -
New FDA Head Selected by President
Mar 14, 2017 | Mesh Medical Device Newsdesk
According to the New York Times, Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards.
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Pelvic mesh victim in the dark about mesh implant for nearly a decade
Mar 15, 2017 | Newcastle Herald
By Joanne McCarthy
LYNDA Garlinge spent nearly 10 years dealing with severe and disabling complications after surgery for incontinence in 2004, without knowing she had been implanted with mesh.
Her doctor was dead by 2014 when she sat in a cafe and read surgery notes saying she had been implanted with Johnson & Johnson mesh without her consent.
“I felt like I’d been raped. That’s how I felt,” said Mrs Garlinge, 65, of the Central Coast.
“I was a normal, hard-working woman with slight incontinence. I was running a business. He said he was going to fix me. He said he’d be able to operate and fix it for me and that it wasn’t a big thing.
“There was no mention of mesh.”
When she woke from surgery Mrs Garlinge was in horrific pain and could not urinate. She remained in hospital for a week.
Her life from that point was not her own, she said.
I felt like I’d been raped. That’s how I felt.- Lynda Garlinge
For a decade she received treatment for an extraordinary cluster of symptoms and pain syndromes.
“The pain just starts like a fire inside and you can’t put it out,” she said.
“It’s like my body is screaming and there’s no explaining it to anyone.”
Mrs Garlinge is one of 450 Australian women in a Shine Lawyers class action against Johnson & Johnson that will be heard from July. The women received mesh to treat incontinence and prolapse. The case is expected to run for six months and will be one of the largest medical civil actions ever run in Australia.
In a defence lodged with the Federal Court in response to the Australian women’s case Johnson & Johnson denied many of the women’s allegations, said that treating surgeons would be expected to inform women of risks associated with mesh surgery, and the company made available information, including warnings, to surgeons. About 4000 Australian women are believed to have been implanted with Johnson & Johnson mesh devices.
In May, 2016 the Attorney-General of the American state of Washington launched civil action against Johnson & Johnson, alleging the company marketed its mesh products as “new and revolutionary”, and knew complications were “caused by the design and placement of the mesh and cannot be avoided by good surgical technique alone”.
In pleadings to the King County Superior Court Attorney-General Robert Ferguson alleged Johnson & Johnson misrepresented the safety and efficacy of its mesh devices, and the polypropylene mesh products “trigger a number of adverse reactions in the human body”.
“The mesh hardens, contracts, erodes into other body organs and becomes so rigid and distorted that complete mesh removal is extremely difficult and often impossible,” Mr Ferguson alleged.
About 12,000 women in the state of Washingon alone were implanted with Johnson & Johnson mesh devices between 2005 and 2015.
Mrs Garlinge said she felt completely betrayed by doctors and Australia’s health system, including peak health regulator the Therapeutic Goods Administration (TGA), which allowed mesh devices to be used in Australia without sufficient evidence supporting their safety.
“The TGA is fully responsible for allowing it into this country. Doctors just like shoving the mesh in. It’s all too easy,” she said.
She cried as she talked about the joy she once experienced as a talented portrait artist.
“I can’t even stand long enough to paint now,” she said.
It was a woman talking to the media about her mesh complications that led Mrs Garlinge to ask for her hospital records, so that she could sit in a cafe and find out the truth.
http://www.theherald.com.au/story/4524066/i-felt-like-id-been-raped-video/
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'I warned women about the 'very frightening' symptoms', says Dr Peter Petros
Mar 15, 2017 | The Daily Advertiser
By Joanne McCarthy
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.
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.”
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?- Barrister Geoffrey Hancy to Dr Peter Petros
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.dailyadvertiser.com.au/story/4531067/doctor-denies-being-blind-to-mesh-risk/?cs=2452
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New FDA Head Selected by President
Mar 14, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 14, 2017 ~ According to the New York Times, Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards.
Dr. Scott Gottlieb, M.D., 44, has ties to pharmaceutical and biotech companies and is a partner at a large venture capital fund, which funds medical startups.
WHO IS SCOTT GOTTLIEB?
Gottlieb is a fellow at the American Enterprise Institute, a conservative think tank based in Washington, D.C., where he researched the FDA and medical reform. The group believes in limited government and personal responsibility.
He is a clinical assistant professor at New York University school of Medicine. Gottlieb was the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007.
Echoing Mr. Trump’s push to bring major changes to the way the FDA does business, including accelerating the process of approving new prescription drugs, Dr. Gottlieb has written about the FDA’s “cumbersome drug approval process.”
“Dr. Gottlieb is someone who has an unprecedented web of financial ties and conflicts of interest to the pharmaceutical industry,” Dr. Michael Carome, director of the Public Citizen’s Health Research Group, told Vocativ.
At the FDA, Carome says Gottlieb often had to recuse himself from decisions. That no doubt would increase if he headed the FDA.
Writing for the American Enterprise Institute, Gottlieb has argued that speeding the drug approval process would slow the rising drug costs by promoting competition between manufacturers.
BACKGROUND
Mesh News Desk (MND) readers already know that 95% of medical devices get to market within about 90 days, so a fast-track clearance process is already in place for most medical device manufacturers.
Congress toughened the way drugs are approved after the Thalidomide crisis in the 1960. The drug was taken by women for nausea during pregnancy but led to severe birth defects. After that debacle the FDA tightened the safety of food and drugs, not medical devices.
Drugs that passed the FDA pre-market approval and clinical trials include the painkiller, Vioxx, which was the subject of intense litigation and a $4.8 billion settlement after at least 2,800 people lost their lives.
Mr. Trump also had Jim O’Neill on his short list to head the agency. O’Neill, a libertarian, used to work at Health and Human Services and has argued that drugs should be introduced into the market without clinical trials and let consumers test them. He is connected to a firm that is working on anti-aging research.
There is currently a presidential freeze on hiring at the FDA. Drug industry leaders tell the New York Times, if drug companies want faster and new kinds of clinical trials approved, they need to fill the estimated 1,000 staff vacancies so decisions can be made more quickly. ###
http://www.meshmedicaldevicenewsdesk.com/new-fda-head-selected-president/
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