Boston Scientific Corp. (NYSE:BSX) issued an official statement urging the FDA to leave transvaginal mesh products under their current classification, despite growing concerns that the products do more harm than good.
The statement comes on the heels of a two-day FDA advisory panel considering revoking 510(k) clearance status for the products and requiring them 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," senior VP and president of urology and women’s health John Pedersen said in prepared remarks. "We believe that the current 510(k) requirements for Class II devices are appropriate for surgical mesh devices intended to treat pelvic organ prolapse and stress urinary incontinence."
During the advisory panel meeting, fellow mesh-maker Cook Medical filed an official letter asking the FDA to give different treatment to meshes made of different materials, arguing that "important differences exist between non-absorbable synthetic mesh products and non-crosslinked biologic grafts."
Other mesh makers, including Johnson & Johnson (NYSE:JNJ) and Endo Pharmaceuticals Holdings Inc. (NSDQ:ENDP), agreed with prior FDA reports that more safety studies and labeling changes could help warn of potential risks. The companies proposed that new applications for transvaginal mesh products require clinical testing, but stopped short of recommending reclassification.
Meeting conclusions have yet to be issued, but the panel appeared to lean heavily toward requiring new devices applications to undergo clinical testing while allowing existing products to stay on the market, AboutLawsuits.com reported.
The panel follows a recent report from the FDA’s Obstetrics & Gynecology Devices Panel which recommended bumping the devices, which are used to treat pelvic organ prolapse, into a higher risk category given rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
Consumer watchdog group Public Citizen filed a petition with the FDA earlier this month asking the agency to issue a recall for all transvaginal mesh products.
Johnson & Johnson and C.R. Bard (NYSE:BCR) and are the target of nearly 500 lawsuits filed by patients claiming the meshes caused internal injuries.
Last month Boston Scientific Corp. and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient. Lawsuits were filed against C.R. Bard Inc. (NYSE:BCR) for its Avaulta transvaginal mesh, filed earlier this month.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency 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."