MedCity article: The transvaginal mesh industry is preparing a major counter campaign against the FDA and Public Citizen. While the FDA and public interest group Public Citizen are calling for increased regulation and even the recall of transvaginal mesh products, the industry — led by lobbyist and trade group AdvaMed — is preparing its own coordinated response.
Just as the FDA is calling an advisory panel to convene on September 8-9, 2011 to discuss the safety and effectiveness of transvaginal surgical mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair, AdvaMed is trying to organize a teleconference next week prior to the committee’s meeting.
AdvaMed is a trade association that represents medical device manufacturers. Trade associations are founded and funded by businesses specializing in a specific industry — in this case, businesses selling medical devices. As a trade group, AdvaMed participates in advertising, education, lobbying and publishing campaigns.
AdvaMed has enlisted newsPRos, a media relations and reputation-management service, to help in its campaign. NewsPRos assists in crisis management.
Said Jeff Secunda, vice president, technology and regulatory affairs at AdvaMed:
“For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option.”
Meanwhile, the FDA warned in 2008 that it had received more than 1,000 complaints of surgical mesh complications. On July 13, the FDA updated the warning, stating they had received an additional 2,874 reports of complications since 2008 and complications are “not rare” in patients. Citing clinical research, the FDA explained that POP repair procedures using transvaginal mesh may place women at a greater risk than traditional non-mesh procedures.
The FDA asked a panel of experts — The Obstetrics-Device Advisory Committee — to convene in order to discuss the FDA’s findings, as well as other clinical data, to decide if transvaginal mesh was a safe and suitable option in POP and SUI repairs.
The committee will also discuss FDA recommendations of increased premarket and postmarket regulations on the transvaginal mesh products. The FDA suggests reclassifying mesh products from Class II to Class III, requiring manufacturers to submit stricter approval applications. The FDA is also pushing for product improvement and postmarket surveillance studies.
Reported complications resulting from transvaginal mesh POP procedures included vaginal mesh erosion, pain, urinary problems and bleeding. There were also seven deaths linked to POP repairs. Three of the deaths were directly associated with mesh placement procedures. It appeared post-operative medical complications led to the other four deaths.
The complications associated with transvaginal mesh procedures prompted Public Citizen, a consumer advocacy group founded by Ralph Nader in 1971, to call for an immediate recall of the devices.
Pelvic organ prolapse occurs when the tissue surrounding the pelvic organ weakens, often as a result of pregnancy or childbirth. Consequently, the organs begin to bulge (or prolapse) into the walls of the vagina, and sometimes even past the vaginal opening. Surgeons have used mesh inserted transvaginally to strengthen the vaginal wall and support the displaced organ.
Stress urinary incontinence is a leakage of urine occurring during physical activity, including coughing, sneezing, laughing or exercise. Transvaginally placed mesh is used to support the urethra in order to treat SUI.
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