Wall Street Journal on Surgical Mesh Post-Market Surveillance Study

Updated May 14, 2013, 4:08 p.m. ET

Outcomes Are Mixed for PelvicProcedure

By SHIRLEY S. WANG   Wall Street Journal   FiDA highlight

A new study finds that long-term benefits are limited for many women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.

The surgery, called abdominal sacrocolpopexy, has been the standard treatment for the gynecological condition for more than three decades, but its outcomes rarely have been studied systematically beyond two years. In addition, there isn't agreement among doctors about what constitutes success for the procedure.

In pelvic organ prolapse, the uterus or vaginal walls "drop" after childbirth and sometimes protrude into or out of the vaginal opening. Most women who have had children vaginally have some degree of prolapse but may not notice symptoms, which can include feeling a bulge in the vagina, a delay in urinary stream and difficulty with defecation.

For some 225,000 women a year in the U.S., the symptoms become so problematic that they get surgery.

Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery, are used to prop up or anchor the organs to keep them in place, sometimes with the use of synthetic mesh. A third operation, used only rarely for older women, closes up the vagina.

The new study, published Tuesday in JAMA, the Journal of the American Medical Association, followed the outcome of more than 200 women for an average of seven years after sacrocolpopexy surgery. It is one of the longest follow-ups to date of such patients.

The study showed that many women receive short-term relief from symptoms and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur over time, and more than 60% develop urinary incontinence, sometimes as a result of the surgery itself.

"Surgery for pelvic organ prolapse isn't perfect," said Ingrid Nygaard, first author on the study and a professor of obstetrics and gynecology at the University of Utah School of Medicine. "It is very good at alleviating symptoms and improving quality of life, but the results may not last forever."

For those who had mesh implanted as part of the procedure, some 10% experienced movement of the mesh from its original location, which "may cause problems for years down the road," said Dr. Nygaard.

The use of synthetic mesh in a related pelvic organ prolapse procedure, in which the mesh is inserted through the vagina rather than through the abdomen, is the subject of hundreds of product-liability lawsuits against mesh makers. The suits allege the women were injured when the mesh failed.

Mesh contraction can occur in the vaginal procedure and cause pain, but mesh movement with the abdominal surgery is unlikely to be painful, according to Dr. Nygaard, who has no ties with mesh makers.

Strategies to prevent pelvic organ prolapse center on pelvic-muscle exercises and childbirth through cesarean section. Some studies have shown such exercises to be effective, and one large epidemiological study in Sweden suggested a link between C-sections and lower risk of the condition. But the preventive effect of C-sections hasn't been studied in a randomized trial.


Further reading:

Jane Akre:  Mesh Device News Desk
http://meshmedicaldevicenewsdesk.com/featured-articles/mesh-fails-25-percent-of-time-in-vaginal-prolapse-repair/

 Ingrid Nygaard:

http://healthcare.utah.edu/fad/mddetail.php?physicianID=u0513310
Study Press Release:
http://www.eurekalert.org/pub_releases/2013-05/tjnj-sel050913.php
JAMA study:
http://media.jamanetwork.com/news-item/study-evaluates-long-term-effectiveness-of-surgery-for-pelvic-organ-prolapse/

Lana Keeton: Patient, Advocate, Victorious!

http://theladyisachamp.blogspot.com

WEDNESDAY, NOVEMBER 28, 2012

MAJOR VICTORY FOR WOMEN AND WOMEN'SHEALTHCARE...PELVIC ORGAN PROLAPSE MESH KITS BITE THE DUST!

Breaking News

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!!

http://www.bloomberg.com/news/2012-01-05/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html

FDA Orders Safety Studies for VaginalImplants Made By J&J and C.R. Bard

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.

Guiding Doctors

“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.

‘Most Studied’

“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.

High-Risk

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.

To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net; David Voreacos in Newark, New Jersey at dvoreacos@bloomberg.net;

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net; Michael Hytha at mhytha@bloomberg.net

Lana Keeton testifies 10/2/2010 at Second Annual Truth In Medicine conference, DC  12 minute YouTube video footage.

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