FDA: Continuing Safety Concerns With Transvaginal Mesh

Mark Crane

Disclosures

July 13, 2011

July 13, 2011 — A dramatic increase in reports of adverse events over the use of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) is a continuing serious safety concern, the US Food and Drug Administration (FDA) announced today.

Serious complications associated with surgical mesh for POP procedures and stress urinary incontinence (SUI) are "not rare," the FDA said in an alert, noting a reversal from its 2008 alert that said they were. "Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk," the FDA said.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said William Maisel, MD, MPH, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, in a news release. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications."

In 2010, at least 100,000 POP repairs used surgical mesh. About 75,000 of these were transvaginal procedures. POP may develop in 30% to 50% of women in their lifetime, with 2% developing symptoms.

An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. Among the reports, 2874 were received in the last 3 years (January 1, 2008, to December 31, 2010), and included 1503 reports associated with POP repairs and 1371 associated with SUI repairs. The number of reports associated with POP repairs increased by more than 5-fold compared with the number of reports received in the previous 3 years (January 1, 2005, to December 31, 2007), according to the FDA.

Between 2008 and 2010, 7 reported deaths were associated with POP repairs. Follow-up investigation revealed that 3 of the deaths were related to the mesh placement procedure (2 bowel perforations, 1 hemorrhage).

POP occurs when the internal structures that support the pelvic organs, such as the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. Women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and defecatory functions; and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

Erosion of mesh through the vagina is the most common and consistently reported complication, the FDA said. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction is a previously unidentified risk. Reports in the literature associate mesh contraction with vaginal shortening, tightening, and pain. Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse, or an inability to engage in sexual intercourse, the FDA noted. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

An FDA review of scientific literature over the past 15 years suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks compared with patients who undergo POP repair with stitches alone. Although mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than nonmesh surgeries.

The FDA urges physicians to recognize that POP can be treated successfully without mesh in most cases. They should consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared with transvaginal POP surgery with mesh.

"Input from the clinicians, manufacturers, and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight," Dr. Maisel said.

The FDA cleared the first surgical mesh product specifically for use in SUI in 1996 and for POP in 2002.

The FDA alert does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.

An FDA advisory committee meeting is planned for September to discuss this issue.

"It's too soon to tell what effect this will have on surgical practice, but we'll definitely be getting a lot of questions from patients," Matthew Barber, MD, president-elect of the American Urogynecologic Society and vice-chair of clinical research in the Women's Health Institute at the Cleveland Clinic, Ohio, told Medscape Medical News.

"The 5-fold increase in reported adverse events is large but may not necessarily reflect a worse rate of complications," he said. "Since the 2008 FDA alert, more physicians became aware of the problem and were more likely to report than before."

"It's important to remember that we use mesh in pelvic reconstruction in many ways," Dr. Barber said. "Placement of mesh through the vagina is just one of them. The FDA report doesn't comment on SUIs, where the role for mesh is more delineated and the risks are less. So I hope we don't overinterpret this alert. I'm eager to see what the advisory committee in September comes up with, particularly about relooking at the approval process for how some mesh products come to market. We need to see better studies before these products are available commercially."

Adverse events related to surgical mesh should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.

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