On October 12th in a letter House Democrats from the Energy and Commerce Committee, led by Representative Henry Waxman of California, Republicans have been urged to hold hearings to examine certain medical devices, more specifically metal-on-metal hip implants like the Depuy ASR and the DePuy Pinnacle, as well as brain stents, both of which have developed serious defects after being implanted in patients, and they cited underregulation as the cause. The House Democrats outlined that the metal-on-metal hip implants have tiny metal particles that wear and enter the bloodstream from the friction of the ball and the cup, per the U.S. Food and Drug Administration (FDA). The agency has received over 5,000 complaints in the first six months of 2011, which was more than the agency had received in the prior four years combined.
The House Democrats went on to explain that approximately 15 percent of patients implanted with the Wingspan stent system to open a clogged brain artery had a stroke or died within 30 days of the procedure, compared with less than 6 percent of patients treated without a stent, citing the New England Journal of Medicine.
This urgent request came as the Committee embarks on the reauthorization of the medical device user fee program. This program collects user fees for certain medical device applications and was established in 2002 to reduce the time required for the agency to review and make decisions about marketing applications. However, a controversial debate continues to question a product’s time to market vs. safety and effectiveness.
“If you ask any of my DePuy clients who have suffered from the metal-on-metal hip implant, I guarantee they would have preferred to have waited to have a reliable product properly tested before being put on the market than to suffer the way they have”.
The Committee has held four hearings this year on the FDA regulation of medical devices, however these hearings have focused on how the FDA regulatory process of medical devices harms patients with time delays and has a negative impact on employment. The House Democrats pointed out that the hearings need to also address the potential dangers posed to patients if medical devices are not properly regulated.
The subject hip implants were cleared for market under the FDA’s controversial 510(k) approval process, which simply requires the manufacturer to show that their product is “substantially equivalent” to existing products on the market.
The subject stents were cleared for market under a humanitarian exemption that lets a manufacturer bypass full premarket approval when the condition affects fewer than 4,000 people, according to the letter.
“If you ask any of my DePuy clients who have suffered from the metal-on-metal hip implant, I guarantee they would have preferred to have waited to have a reliable product properly tested before being put on the market than to suffer the way they have” said Attorney David Ennis. “I agree with the House Democrat’s position whole-heartedly.” The House Democrats concluded in their correspondence that this was a “critical opportunity to improve the efficiency of the process while at the same time strengthening assurances of safety and efficacy.”
To read the letter in full click here.