WEDNESDAY, NOVEMBER 28, 2012
Major Victory for Women!
And for Women’s Health Care!
Dateline: Miami, November 28, 2012
By Lana C. Keeton (copyright protected)
The Center for Devices and Radiological Health (CDRH) will be up-classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year.
Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.
The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.
And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.
Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.
Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!
Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.
And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.
Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.
Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!
By Alex Nussbaum & David Voreacos - Jan 5, 2012 3:19 PM CT
Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.
The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel (see FiDA blog dated 11/2/12 High Standards for FDA Leaders? FDA Official Pleads Guilty to Prostitution Charge, Gets One Day of Probation) said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing.
“Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. While companies say implants are safe, “up until now, there’s been no data,” she said. “It’s all been marketing.”
J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1 percent to $65.40 at the close in New York. C.R. Bard also declined (BCR) less than 1 percent to $85.94. J&J is based in New Brunswick, New Jersey, and C.R. Bard in Murray Hill, New Jersey.
The letters ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided a benefit over older methods in certain cases.
“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” said Maisel, deputy director of science for the agency’s device- approval center. “Our goal is to make sure the right women use it at the right time.”
The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific (BSX) Corp. mesh recalled for safety concerns in 1999.
Yesterday’s letters covered only devices already on the market. Consumer groups say they want the action to be just a first step toward requiring studies before the products can reach the market, said Amy Allina, a policy director at the National Women’s Health Network in Washington.
‘The Right Thing’
“It would have been better if the products that had hurt women had never gone out in the first place,” she said in a telephone interview. “But now that they’re out there, we’re encouraged to see the FDA doing the right thing and requiring the companies to provide more information.”
Even before the studies are done, they will serve to warn off patients, said Keeton, the Texas woman and founder of the group Truth in Medicine.
“What woman’s going to sign up for a study when they know” the potential complications, she said by telephone.
Keeton sued J&J over injuries she blamed on a 2001 implant. The case was dismissed by a federal judge in 2007. She has also worked as a paid consultant to lawyers suing mesh makers.
Matthew Johnson, a spokesman for J&J’s Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA.
“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said in an e-mail.
The FDA letters also went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific, based in Natick, Massachusetts. The companies have 30 days to respond.
Kevin Wiggins from Endo Pharmaceuticals and Eric Olson from Boston Scientific didn’t return phone calls seeking comment. Scott Lowry, a C.R. Bard spokesman, also didn’t return a message.
The edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University (43935MF) School of Medicine, in a telephone interview last year.
In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said. The agency isn’t likely to heed the call of some patient advocates for a complete recall, he said.
“There’s strong support in the clinical community that mesh serves a role for certain patients,” Maisel said. “Our goal is not to completely remove these products from the market.”
Manufacturers sell about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments, C.R. Bard executives estimated on a conference call in 2010. Even for the top sellers, the products make up only about 1 percent to 2 percent of sales, said Michael Matson, a Mizuho Securities USA analyst in New York.
“Patients are already well aware of these issues and the markets have been declining already,” he said.
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Lana Keeton testifies 10/2/2010 at Second Annual Truth In Medicine conference, DC 12 minute YouTube video footage.