FDA Panel – No Decision on Metal HipsJun 30th, 2012 | By Jane Akre | Category: FDA News
June 30, 2012 ~The U.S. Food and Drug Administration (FDA) convened an 18-member expert panel to look at the large number of complications arising from metal-on-metal (MoM) hip replacements in patients.
Dr. William Rohr opened the proceedings on June 27 saying they were not there to discuss reclassification of the hip, and the experts were not expected to take a vote at its conclusion the next day as is customary for an FDA expert panel.
The 18-member FDA advisory panel was made up of surgeons, industry reps, and consumer advocates to try and come up with some policy recommendations for use of the MoM hip implants that have left so many with life-altering complications such as cobalt and chromium toxicity, dislocations, early revisions, pain and infection, among other problems.
MoM hips were originally marketed as an alternative to the traditional ceramic or plastic hips and were targeted for the younger, more active hip recipient. Many patients are in their 40s and 50s with a lifetime of injury and complications ahead.
There was no consensus on how to treat patients who suffer from toxic metal levels of chromium or cobalt coming from the metal debris which gets into the bloodstream in patients from the wear of MoM hips.
In the audience were a number of metal hip-injured people who testified, while a couple submitted videotaped testimony.
Hip Recipients Testify
Among them was Sharee Winslow, a yacht captain from St. Thomas, Virgin Islands, who told the panel she’s sailed every sea for 26 years. “When I got this (titanium) hip I was told it was the Mercedes and I trusted you people.” She continued, “I don’t deserve it, Take a deep breath and think about your mother, your sister, daughter, who are getting these hips that are not designed properly. Who is paying this bill? The American taxpayer because I’ve had to go on disability, Social Security, Medicare and Medicaid and I’m way too young for that.”
She also has closed her business because a captain takes an oath to provide for the safety and security of her crew which Winslow says she can now not guarantee.
Howard Sadwin, 66, from Sarasota, Florida, who was profiled on MDND said his Smith & Nephew metal-on-metal hip was removed, surgeons found a “grey mush” inside the hip socket. He spent 10 months in the hospital fighting the infection that overtook his body.
Hip recipient, Lisa Moore told the panelists, “When I think about the part DePuy was able to market without studies, I feel like a human guinea pig.”
Moore was referring to the 510(k) approval process that allowed most metal hips to enter the marketplace with no requirement for safety and efficacy testing.
Not one of the patients who testified had understood that their medical device maker was not required to submit clinical studies to assure patient safety before selling their device.
Johnson & Johnson and its DePuy Orthopaedics division face more than 6,ooo lawsuits in federal and state court over injuries associated with the ASR metal hip, which Moore received along with approximately 93,000 patients worldwide.
Elizabeth Frank, a Biomedical Engineer with the FDA reminded the panel that MoM hips are a Class III device and that as of May 30, 2012, the agency had cleared 188 510(k) submissions from 21 manufacturers for MoM total hip replacement systems (THR) under 510(k). Many of those approvals were for additional components.
There are five manufacturers of MoM THR systems marketed in the U.S., they include Biomet, Inc.; DePuy Orthopaedics, Inc. (Johnson & Johnson); Encore Medical, L.P.; Wright Medical Technology, Inc.; and Zimmer, Inc.
Agreement was reached on a number of issues – that data had not been submitted to compare MoM implants with other hips such as those made of metal-on-polyethylene; that women seem to have more complications than men; that the larger the head size of the implant, the more failures; that there is no identifiable patient group for whom MoM hips should be the first choice; and that no one knows what a ‘out of range’ cobalt and chromium levels mean.
A review of the 600 members of the American Association of Orthopaedic Surgeons finds that only 1.4% are still implanting the MoM devices, according to a representative.
Still, what to do with the estimated 500,000 to 750,000 in the U.S. alone who have been implanted with MoM hips remains an unanswered question. Johnson & Johnson and its DePuy Orthopaedics division face more than 6,ooo lawsuits in federal and state court over injuries associated with the ASR metal hip which was recalled in August 2010.
There was no discussion on revising the 510(k) approval process which allows MoM hips as well as synthetic vaginal mesh to make it to the market with little assurances of patient safety. #