After years of reports concerning patients who suffered severe pain and in some instances death, the U.S. Food and Drug Administration
is seeking to reclassify some surgical meshes as high-risk devices, which would require manufacturers to conduct studies showing the products are safe and effective.
In a proposed order
, the FDA calls for the reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse. A second proposed order
asks that instruments used in the procedures be reclassified as intermediate-risk instead of low-risk devices. Comments on the documents are due July 30.
Surgical meshes are used to provide support in repairing weakened or damaged tissue. Today, manufacturers get approval for the devices based on comparing their mesh to similar products on the market, using the FDA’s 510(k) premarket notification process.
The FDA's proposal comes nearly three years after the agency convened an advisory panel recommending the reclassification. The FDA received 1,503 adverse-event reports involving the products between 2008 and 2010, five times as many as it did between 2005 and 2007, the FDA said at the time. Reported issues included seven deaths, 1,215 injuries, 279 malfunctions and two reports labeled as “other,” the agency said. Consumers most often reported pain, tissue erosion, infection, urinary problems and organ perforation.
The federal agency estimates that its orders will affect 14 manufacturers including Boston Scientific
, Covidien, C.R. Bard and American Medical Systems.
A representative from Boston Scientific maintained in a statement that it is dedicated to delivering safe, high-quality products for women with pelvic-floor disorders, and is continuing to work with the FDA to ensure that appropriate information regarding mesh products is provided to patients and physicians.
If the orders are finalized, manufacturers will need to submit a new application within 90 days of the effective date. The devicemakers
will be allowed to continue marketing the products while they wait for FDA review of their applications, but would have to stop selling them if their applications are denied. Any new devices would need to go through the regulatory pathway for high-risk devices.
Reclassification of a medical device has historically triggered federal-rulemaking procedures, which require the agency to estimate the cost to stakeholders. However, the FDA is invoking its authority under the 2012 Food and Drug Administration Safety and Innovation Act, or FDASIA, which allows the agency to act more quickly to address a device shown to cause harm.
The FDA action follows thousands of lawsuits against manufacturers filed by consumers in the past decade.
On April 30, Endo International announced it would pay about $830 million to resolve nearly 20,000 lawsuits claiming its vaginal-mesh implants eroded in some women and left them incontinent and in pain.
Other companies, including Johnson & Johnson subsidiary Ethicon, have begun pulling the devices off the market in recent years amid negative news reports on the products and growing regulatory scrutiny.Follow Virgil Dickson on Twitter: @MHvdickson