Preview Newsletter
Ethicon Media Monitoring 3/2/2017
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Senator Derryn Hinch urges women to make submissions to a Senate inquiry into pelvic mesh devices
Mar 2, 2017 | Newcastle Herald
By Joanne McCarthy
Derryn Hinch says his fight for justice for women victims of “one of the biggest medical scandals in history” – many living in the Hunter – will probably end up being “the most important thing I do here”. -
Sullivan V Boston Scientific Pelvic Mesh Case Settles on Eve of Trial
Mar 1, 2017 | Mesh Medical Device Newsdesk
The March 13th pelvic mesh trial of Sullivan v. Boston Scientific will not be heard because it has settled. There is no word on the specifics of that settlement. It is the first of many cases poised to go to trial in the Philadelphia Court of Common Pleas.
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Senator Derryn Hinch urges women to make submissions to a Senate inquiry into pelvic mesh devices
Mar 2, 2017 | Newcastle Herald
By Joanne McCarthy
SENATOR Derryn Hinch says his fight for justice for women victims of “one of the biggest medical scandals in history” – many living in the Hunter – will probably end up being “the most important thing I do here”.
The former journalist once known as the “human headline”, who won bipartisan support for a Senate inquiry into how pelvic mesh devices were sold in Australia, said he had clear goals for what he wanted to achieve when he stood for politics: “Hoping to rewrite or scrap some old laws and bring in some new ones”.
He added a new goal after meeting women left to deal with catastrophic injuries following pelvic mesh implant surgery to treat common pelvic organ prolapse problems after pregnancy and birth.
“I said in my speech to the Senate that it was one of the greatest medical scandals and abuses of mothers in Australia's history,” he said.
“People accused me of hyperbole when I made that speech. If anything, I understated the situation. When a woman gets on the red-eye from Perth so she can see me the next morning, or when another woman drives from Port Pirie to tell me what she’s been through, you know the situation is extreme, and it is.”
The Senate inquiry, established on February 15, has called for submissions from affected women and any related individuals or groups with knowledge of devices known as transvaginal mesh. Submissions should be received by May 31.The Senate community affairs references committee will hold public hearings across the country to hear evidence about the consequences of mesh surgery and hear from regulators about how the devices were approved.
The Newcastle Herald has previously revealed that mesh devices were approved for prolapse surgery in Australia without clinical evidence of safety and efficacy.
This was after the American Food and Drug Administration (FDA) in 2001 approved the first prolapse mesh device for surgery through a woman’s vagina based on it being “substantially equivalent” to an existing device used in surgery to treat women for urinary incontinence.
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, 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.
People accused me of hyperbole when I made that speech. If anything, I understated the situation.- Senator Derryn Hinch
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.
In a passionate speech to the Australian Senate in November, Senator Hinch said Australian medical watchdogs like the Therapeutic Goods Administration (TGA), which registered mesh devices for use, had let women down.
The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices used for incontinence surgery cases.
The women – many from the Hunter – were then “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA”, Senator Hinch said in his November speech.
His background as a journalist who championed the victims of child sexual abuse, and his recent health battles leading to a liver transplant, meant he was more aware than many politicians of how betrayed and abandoned women left with catastrophic injuries felt, he said.
“You trust your doctor. I know how desperate you can get when you need treatment. When people say they have cures for you, you’ll listen to them. Doctors are some of the most respected people in the community. Doctors are gods. We need to find out how this happened. How the trust these women placed in doctors and our health system was so betrayed,” Senator Hinch said.
”Here we have a situation where you have one device approved and you can use that approval to get another device approved for a different problem. It seems crazy to me.
“I want women to make submissions. This is the chance for their voices to be heard.”
http://www.theherald.com.au/story/4501467/this-will-be-the-most-important-thing-i-do-here/
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Sullivan V Boston Scientific Pelvic Mesh Case Settles on Eve of Trial
Mar 1, 2017 | Mesh Medical Device Newsdesk
The March 13th pelvic mesh trial of Sullivan v. Boston Scientific will not be heard because it has settled. There is no word on the specifics of that settlement. It is the first of many cases poised to go to trial in the Philadelphia Court of Common Pleas.
Sullivan v. Boston Scientific, Inc. et al (Case ID 130700971) named as its defendant Boston Scientific (BSC) from Natick, Mass and Secant Medical Inc. of Perkasie, PA and Prodesco Inc also of Perkasie, PA.
The Kline Specter firm represented Ms. Sullivan.
The case had received a Trial Date Certain from Judge Arnold New of March 13th.
Now MND has learned Sullivan has settled. Specifics are not available but yesterday, February 28, Susan Donnelly Murphy petitioned the court to be brought into the Sullivan case.
“She has a successful record of resolving lawsuits via trial, mediation, arbitration & dispositive motions,” says a write up on her Murphy & Riley law firm of Mass.
In her 30-page complaint, Sullivan received the Uphold vaginal support system to treat pelvic organ prolapse and stress urinary incontinence. Secant Medical and/or Boston Scientific designed, tested, inspected, wove, cut, treated, packaged, manufactured and marketed the mesh made from polypropylene. Secant sold the mesh components of BSC products.
On November 22, 2010 Sullivan was implanted with one or more of BSC mesh products and or Secant’s mesh components, by Dr. Stephen A. Metz at Mercy Medical Center in Springfield, Mass. He is board certified in obstetrics and gynecology.
He performed a bilateral sacrospinous ligament colposuspension, posterior colporrhalphy with repair of the perineal body, and a cystoscopy.
Uphold is made of Marlex polypropylene, a double-armed mesh placed using a Capio device. Its design is based on the Pinnacle mesh, with the difference being the shape of the mesh. There were no trials pre-market to determine whether the new design was safe and effective.
Uphold was placed on the market through the FDA’s 510(k) clearance for marketing on August 22, 2008. It has been replaced by Uphold Lite.
On July 14, 2011, Dr. Metz excised the exposed mesh from the vaginal wall and placed an AMS Monarc mid-urethral sling in Ms. Sullivan.
“As a result of having the Pelvic Mesh Products and/or the Mesh Components implanted in her, Plaintiff has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, but not limited to, obligations for medical services and expenses.”
“Injuries include, but are not limited to, mesh erosion, exposure, contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and/or recurrent urinary incontinence.”
The Complaint goes on to say the Defendants market their Pelvic Mesh Products to the medical community through carefully planned, multifaceted marketing campaigns and strategies. Direct to consumer advertising, aggressive marketing to health care providers at medical conferences, hospitals and private offices. BSC has failed to report high failure injury, complication rates, failure to perform as intended, re-operations and severe irreversible injuries.
BSC has “consistently under reported and withheld information about the propensity of their Pelvic Mesh Products and/or Mesh components manufactured by the Secant medical Defendants.
They know their disclosures to the FDA were and are incomplete and misleading and that their mesh components are causing numerous patients severe injuries and complications Boston Scientific consistently suppresses this information and failed to share with the FDA, health care providers and the patients. BSC provides insufficient and misleading training and information to physicians to increase its use. “As a result, the Defendant Boston Scientific actively and intentionally misled and continues to mislead the public….”Sullivan V Boston Scientific Pelvic Mesh Case Settles on Eve of Trial
Philadelphia Court of Common Pleas
Mesh News Desk, (MND) March 1, 2017~ The March 13th pelvic mesh trial of Sullivan v. Boston Scientific will not be heard because it has settled. There is no word on the specifics of that settlement. It is the first of many cases poised to go to trial in the Philadelphia Court of Common Pleas.
Sullivan v. Boston Scientific, Inc. et al (Case ID 130700971) named as its defendant Boston Scientific (BSC) from Natick, Mass and Secant Medical Inc. of Perkasie, PA and Prodesco Inc also of Perkasie, PA.
The Kline Specter firm represented Ms. Sullivan.
The case had received a Trial Date Certain from Judge Arnold New of March 13th.
Susan Donnelly Murphy
Now MND has learned Sullivan has settled. Specifics are not available but yesterday, February 28, Susan Donnelly Murphy petitioned the court to be brought into the Sullivan case.
“She has a successful record of resolving lawsuits via trial, mediation, arbitration & dispositive motions,” says a write up on her Murphy & Riley law firm of Mass.
In her 30-page complaint, Sullivan received the Uphold vaginal support system to treat pelvic organ prolapse and stress urinary incontinence. Secant Medical and/or Boston Scientific designed, tested, inspected, wove, cut, treated, packaged, manufactured and marketed the mesh made from polypropylene. Secant sold the mesh components of BSC products.
Marlex Mesh, Phillips Petroleum ad
On November 22, 2010 Sullivan was implanted with one or more of BSC mesh products and or Secant’s mesh components, by Dr. Stephen A. Metz at Mercy Medical Center in Springfield, Mass. He is board certified in obstetrics and gynecology.
He performed a bilateral sacrospinous ligament colposuspension, posterior colporrhalphy with repair of the perineal body, and a cystoscopy.
Uphold Lite from BSC website
Uphold is made of Marlex polypropylene, a double-armed mesh placed using a Capio device. Its design is based on the Pinnacle mesh, with the difference being the shape of the mesh. There were no trials pre-market to determine whether the new design was safe and effective.
Uphold was placed on the market through the FDA’s 510(k) clearance for marketing on August 22, 2008. It has been replaced by Uphold Lite.
On July 14, 2011, Dr. Metz excised the exposed mesh from the vaginal wall and placed an AMS Monarc mid-urethral sling in Ms. Sullivan.
“As a result of having the Pelvic Mesh Products and/or the Mesh Components implanted in her, Plaintiff has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, but not limited to, obligations for medical services and expenses.”
“Injuries include, but are not limited to, mesh erosion, exposure, contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain and/or recurrent urinary incontinence.”
AUGS conference
The Complaint goes on to say the Defendants market their Pelvic Mesh Products to the medical community through carefully planned, multifaceted marketing campaigns and strategies. Direct to consumer advertising, aggressive marketing to health care providers at medical conferences, hospitals and private offices. BSC has failed to report high failure injury, complication rates, failure to perform as intended, re-operations and severe irreversible injuries.
BSC has “consistently under reported and withheld information about the propensity of their Pelvic Mesh Products and/or Mesh components manufactured by the Secant medical Defendants.
They know their disclosures to the FDA were and are incomplete and misleading and that their mesh components are causing numerous patients severe injuries and complications Boston Scientific consistently suppresses this information and failed to share with the FDA, health care providers and the patients. BSC provides insufficient and misleading training and information to physicians to increase its use. “As a result, the Defendant Boston Scientific actively and intentionally misled and continues to mislead the public….”
There were safer alternative designs and products as well as suitable alternative procedures and instruments for implantation and treatment of POP.
The Defendants failed to properly and adequately warn the Plaintiff or her physician. They were negligent in the manufacture, warning, sale and training of doctors to implant the mesh. Common law fraud means the Defendant falsely and fraudulently represented their medical device as safe and effective with a “callous, reckless, willful, and depraved indifference to the health, safety, and welfare of Plaintiff.”
Negligent infliction of emotional distress, Breach of Express Warranty- safe and fit for use by consumers. Breach of implied warranty, violation of consumer protection laws by making false deceptive representations and advertising, violating statutes that were enacted to protect consumers. Gross negligence is malice fraud, grossly negligent disregard for the rights of others.
The complaint is signed by Thomas R. Kline, Lee Balefsky and Michelle Tiger as well as attorneys from Aylstock Witkin Kreis and Overholtz of Pensacola.
A call into Boston Scientific’s media office about whether or not BSC has conducted its clinical testing of its pelvic mesh products as ordered by the FDA, January 2012, was not answered by publishing time. It will be added if there is a response.
A Mass. appeals court decided last September that the Albright case against Boston Scientific should receive a new trial because of information omitted by the Massachusetts trial court judge. See MND coverage here.
A RICO case was filed last June in federal court in Charleston, WV alleging Boston Scientific purchased counterfeit Marlex to make its pelvic mesh from a Chinese counterfeiter. See MNDcoverage here.A North Carolina jury found for Boston Scientific and its Uphold mesh in the trial of Carlson v. Boston Scientific, October, 2015. See MND coverage here.
http://www.meshmedicaldevicenewsdesk.com/sullivan-v-boston-scientific-pelvic-mesh-case-settles-eve-trial/
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