House Dems Want Hearing to Discuss Device Safety

A group of Democrats on the Energy and Commerce Committee in the U.S House of Representatives sent a letter to Republican committee leaders on Jan. 20, requesting hearings to examine the safety of implanted medical devices that have developed serious defects.

Specifically cited in the letter were the Lap-Band weight-loss device made by Allergan Inc. and urogynecologic surgical mesh made by a number of medical device manufacturers. This recent request follows an October call for hearings on two other medical devices that have caused serious problems: stents and metal-on-metal hip implants .

“The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation,” the representatives wrote in the letter, adding “We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act.”

The medical device user fee program of the U.S. Food and Drug Administration (FDA) is up for renewal this year (it expires in September) and discussions among the agency, industry and lawmakers are ongoing. The lawmakers said holding hearings would provide important information for members to evaluate in the context of the reauthorization of medical device user fees

The FDA was required to submit final recommendations to Congress by Jan. 15, but the agency missed the deadline.

Signing the letter were: Energy and Commerce Ranking Member Henry A. Waxman (Calif.) and Reps. Diana DeGette (Colo.), and John D. Dingell (Mich.). The letter was sent to Upton; Joseph R. Pitts (Pa.), chairman of the Health Subcommittee; and Cliff Stearns (Fla.), chairman of the panel’s Subcommittee on Oversight and Investigations.

The Lap-Band is surgically implanted around the upper portion of a patient’s stomach to reduce its size. The FDA approved the device for obese patients but highlighted that it can pose serious risks, including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.

“The adverse public health consequences associated with use of this device are exacerbated by aggressive marketing and by the lack of a national registry of implanted medical devices, like those that exist in Europe, which would enable public health authorities to obtain more accurate data on the rates of adverse events and device failures,” according to the letter.

Vaginal surgical mesh implant were permitted on the market under the 510(k) process. Earlier this month, the FDA announced that it would require manufacturers to conduct studies of the surgical mesh implants because of concerns over their safety and effectiveness. The agency also said it was considering reclassifying the devices from moderate-risk (Class II) to highest risk (Class III), which would require clinical data to be submitted for approval.