Consumer Reports is blasting the way the U.S. Food & Drug Administration (FDA) approves medical devices, citing recent problems with metal-on-metal hip implants and transvaginal mesh products as evidence of the agency’s inadequacy. As we’ve reported in the past, both metal-on-metal hip implants and transvaginal mesh were approved via the FDA’s infamous 510(k) clearance program, which does not require that a device undergo human tests if a manufacturer can show it is “substantially equivalent” to another already approved for sale. According to Consumer Reports, these types of approvals only require manufacturers to file some paperwork and fork over a $4,000 user fee to the FDA. As a result, problems with devices – such as those now being seen among transvaginal mesh and all-metal hip implant recipients – don’t become apparent until they’ve been used in thousands of patients.
According to Consumer Reports, hundreds of thousands of women have been implanted with transvaginal mesh devices to repair pelvic organ prolapse and stress urinary incontinence since they first came on the market about a decade ago. It’s now known that many of those women have since suffered serious and life-changing complications from these devices, including scarring, chronic infections, extrusion of the mesh through the vaginal wall, and other malfunctions that have made their lives torture. According to Consumer Reports, the trasvaginal mesh kits mesh causing this misery were cleared based on their “substantial equivalence” to an earlier mesh used to repair abdominal hernias that was first sold in the 1950s, even though the kits were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.
Public Citizen, which has called transvaginal mesh the “poster-child’ for the FDA’s “fundamental failure … to protect the public’s health and welfare,” has called for a recall of the products. As we’ve reported, the FDA is reviewing their safety, and has asked the makers of transvaginal mesh to conduct post-market studies of the devices. But according to Consumer Reports, transvaginal mesh kits remain on the market and are still classed as “moderate risk” devices.
According to Consumer Reports, metal-on-metal hip implants, including DePuy Orthopaedics’ now-recalled ASR XL Acetabular Hip Replacement System, also made it to the market untested, based on the “substantial equivalency” rule. As we’ve been reporting for some time, metal-on-metal hip implants are now the subject of controversy over concerns that they are shedding dangerous amounts of toxic metal ions into patients’ blood streams, putting them at risk of cobalt poisoning and long-term health problems. According to Consumer Reports, from 2009 through 2011, the FDA received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the DePuy ASR Hip Implant. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S.
Even medical devices that aren’t eligible for 510(k) approvals, like the Lap-Band surgical weight loss device, are subject to minimal testing. According to Consumer Reports, the FDA approved the Lap-Band based on a single study, involving just 229 patients. Of those, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight.
“Imagine if a car had a recall rate that high,” John Santa, M.D., director of the Consumer Reports Health Ratings Center, said. “Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden.”