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FDA warns mesh used in surgery poses risk

Problems seen in vaginal procedure

By Deborah Kotz and Robert Weisman
Globe Staff / July 14, 2011

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Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.

The agency warned patients and surgeons to consider other options.

The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh - manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies - for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, the agency said, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include pain ful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

“I’m in constant pelvic pain,’’ said Jill Goodwin, a New Hampshire health care worker who had mesh sold by C.R. Bard Inc. implanted in 2008 and has since suffered abdominal bleeding and pelvic nerve damage. “I have spasms all the time, and I’m limited in what I can do. Some days it’s all I can do to get out of bed.’’

Bard officials did not respond to a phone call and e-mail seeking comment.

For many of the manufacturers, the mesh is just one of many products and generates a small portion of sales. But the FDA action could lead to a flurry of new lawsuits.

Boston Scientific, which has had a string of setbacks stemming from its cardiac devices in recent years, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.

“If the product is defective when it’s used in the manner intended by the manufacturer, there’s liability,’’ said Tom Girardi, senior partner at the Girardi Keese law firm in Los Angeles, which represents about 75 patients who used Boston Scientific’s mesh. “It is unfortunate that the FDA doesn’t come to these conclusions before all these people get hurt.’’

Boston Scientific executives said yesterday that they are looking into the issue but would not say whether they plan to continue selling the mesh for vaginal surgery.

Covidien, a company incorporated in Ireland with its corporate headquarters in Mansfield, supplies mesh to Bard, which markets it to health care providers to treat pelvic organ prolapse.

“We are not selling any mesh for this indication,’’ said Covidien spokesman Bruce Farmer. “We do supply product for Bard, which they use for this indication.’’

Henry Garrard, senior partner at the Athens, Ga., law firm of Blasingame Burch Garrard and Ashley, which represents Goodwin and more than 100 others in a complaint against Bard lodged in federal court in West Virginia, said the manufacturers initially designed the mesh for hernia repair.

While regulators gave companies clearance to market it for pelvic organ prolapse repair, “they did not look to see if, mechanically or otherwise, these products worked in the pelvis,’’ Garrard said. “They should have known that they needed to check and test.’’

Shares of Boston Scientific fell 10 cents to $7.18 yesterday, a 1.37 percent drop on the New York Stock Exchange. Covidien shares edged up 29 cents, or 0.55 percent, to $52.94.

In 2008, the FDA announced that “rare’’ problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended.

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.

Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Less commonly, the mesh becomes so intertwined with scar tissue that it cannot be removed.

“For women with unresolved pain from mesh that can’t be removed, their options can be limited,’’ said FDA medical officer Dr. Jill Brown.

What’s more, the FDA found that the mesh does not make the surgery any more effective.

“The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapsed repairs,’’ said Dr. William Maisel, the FDA’s deputy director of the Center for Devices and Radiological Health.

In 2010, 75,000 women had vaginal surgery with mesh to repair pelvic organ prolapse. That surgery was performed three times as often as abdominal surgical mesh repair, according to the FDA, since it does not require a painful incision through the skin and offers a less painful recuperation for women.

Dr. May Wakamatsu, head of the urogynecology division at Massachusetts General Hospital, said she and the two other surgeons at the hospital who repair pelvic organ prolapse have largely switched to the abdominal surgery using a laparascope or robotic device that involves making small incisions in the skin.

“We find ourselves doing the vaginal surgery less and less,’’ Wakamatsu said, “only on complicated patients with previous abdominal surgeries, endometriosis, or congenital defects.’’ She said in her experience the mesh, when inserted through the abdomen, was helpful in providing support for organs after repair.

The FDA cited studies showing abdominal mesh repair for pelvic organ prolapse led to vaginal erosion in 4 percent of women within 23 months of surgery.

Even with yesterday’s FDA announcement, surgeons can still opt to use the mesh for vaginal pelvic organ prolapse repair. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

For Boston Scientific, the mesh safety alert follows numerous problems it has encountered in recent years involving two of its best-selling cardiac products: tiny mesh tubes known as stents that are implanted to keep cleared arteries open and implantable devices called defibrillators that apply electric shocks to restore heart rhythm.

Kotz can be reached at dkotz@globe.com; Weisman at weisman@globe.com.

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