California Representative Henry Waxman of California and three other House Democrats on the Energy and Commerce Committee have petitioned Committee Republicans to investigate metal-on-metal hip implants, including DePuy’s recalled ASR systems and other possibly faulty medical devices, citing insufficient regulation as the reason why these products may have harmed so many Americans.
Mr. Waxman and the other Democrats explained the “unique risks” of metal-on-metal hip implants, which an estimated 500,000 people in the United States have received. About 37,000 of those patients have received one of DePuy’s recalled ASR hip implants, and many of those patients are now suing the company and its parent, Johnson and Johnson, over severe damages the hip implants allegedly caused.
“Because the metal rubs against the metal, tiny metal particles may wear off of the device and enter into the space around the implant … or even get into the bloodstream,” the letter stated, citing a recent Food and Drug Administration analysis.
“For some patients, these metal particles can cause damage to the bone or tissue surrounding the implant and joint, requiring a surgery to replace the implant,” the letter continued. “In addition to the local reactions, high levels of metal ions in the bloodstream may cause symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.”
The Democrats acknowledge inefficiencies in the FDA, but said that hearings so far have focused on approval delays and over-regulation, providing an “incomplete record” of the agency’s failures. They urged the Republicans to “hold hearings on the recent Institute of Medicine report, which concluded that our current review system needs to be strengthened – not weakened – to ensure that medical devices are safe and effective.”
Allegedly faulty hip implant devices were fast-tracked through the FDA’s approval process via the 510k program, which allows certain devices to clear approval without clinical testing if they are substantially similar to already approved devices. “Although clinical data can be required under this clearance process,” the letter stated, “many submissions are cleared without such data … many of the metal-on-metal hip systems were cleared this way.”
According to the New York Times, the FDA has been flooded with complaints about all-metal hip implants made by DePuy and other manufacturers. In the first 6 months of 2011, the agency received more than 5,000 complaints about all-metal hips – more than the total number of such complaints from the previous four years combined.
Many of the complaints concern DePuy’s recalled hip devices, which remains on the market. The surge of complaints and lawsuits over all-metal implants prompted the FDA to order 20 manufacturers of the devices to submit a plan of study examining how frequently the devices failed the implications their failure on the health of patients.
The New York Times