Boston Scientific has officially asked the FDA to reconsider its questioning of the safety of transvaginal mesh products used in surgery. John Pedersen, the company’s senior vice president and president of its urology and women's health division, responded in writing on Sept. 9 to an FDA advisory panel considering the revocation of 510(k) clearance status for these products.
If FDA gives the thumbs-down, the products will have to undergo clinical testing as higher risk Class III medical devices.
“Boston Scientific believes that mesh products are a valuable option for surgeons who treat women with pelvic floor disorders and stress urinary incontinence and that these products offer a safe and effective alternative to non-mesh treatment options,” wrote Pederson. “We will continue to work with the FDA and other members of the AdvaMed Working Group to reinforce the safety and effectiveness of these devices.”
The Wall Street Journal reported that products in this category are also made by C.R. Bard and Johnson & Johnson. The Advanced Medical Technology Association (AdvaMed), the Washington trade group that lobbies on behalf of medical device makers, told the paper that complication rates have improved as newer and better mesh products have been developed. The group said serious side effects were less than 2 percent of reported side effects.