Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
By Nathaniel Weixel
A group of Democratic members of the House Energy and Commerce Committee sent a letter to Republican committee leaders Jan. 20, urging them to hold hearings to examine medical devices that have developed serious defects after being implanted in patients.
The members are also urging the committee to seek documents related to the Lap-Band weight loss device and urogynecologic surgical mesh.
This request follows an October request for hearings on two other medical devices that have caused serious problems: stents and metal-on-metal hip implants (5 MELR 640, 10/19/11).
“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 letter stated.
For example, in a Feb. 17, 2011, hearing, Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said device companies “are being forced to market their devices first in Europe because the EU countries have predictable and consistent regulatory processes” (5 MELR 119, 2/23/11).
The Democrats said, “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 letter was signed by 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 Democrats in the letter urged the committee to hold hearings “to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh.”
The Lap-Band is a gastric band device that is surgically implanted and wrapped around the upper portion of a patient's stomach to reduce its size. FDA approved the device for obese patients but has indicated that the device 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 Democrats said in the letter.
According to the letter, Allergan, which manufactures the device, is seeking FDA approval to market the Lap-Band to children as young as 14, despite concerns among some physicians that the procedure is too drastic or extreme for a young person's developing body.
“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,” the letter stated.
FDA in December sent warning letters to a California marketing company and several California surgical centers that sell the Lap-Band, telling them to immediately pull advertisements for the device that fail to adequately warn consumers about its risks (6 MELR 16, 1/11/12).
Urogynecologic surgical mesh implant were permitted on the market under the 510(k) premarket notification process, meaning that the devices had to demonstrate that they were substantially equivalent to a device already on the market.
According to the House Democrats, beginning in October 2008, FDA started responding to rising reports of complications associated with the surgical mesh by issuing a Public Health Notification calling the transvaginal placement of the mesh “an area of continuing concern.”
FDA on Jan. 4 announced that it was requiring certain manufacturers to conduct studies of urogynecologic surgical mesh implants because of concerns over their safety and effectiveness. The agency also said it was considering reclassifying the devices from moderate-risk, or class II, to highest risk, or class III, which would require clinical data to be submitted for approval (6 MELR 20, 1/11/12).
“It is unclear when the manufacturers of this device became aware of the serious health risks associated with the device,” the letter said. “It is also unclear if the manufacturers and the FDA have taken appropriate steps to protect patients.”
The Democrats further asked that the committee seek documents relevant to both the Lap-Band and intravaginal mesh devices.
“In the case of the Lap-Band, we urge you to request documents from Allergan, 1-800-GET-THIN, LLC, and the eight surgical centers named in the FDA's warning letters to learn the degree to which these entities cooperated in the marketing of the Lap-Band, what steps were taken to minimize the risks the aggressive marketing campaign posed to patients and children in particular, and to obtain additional information regarding their knowledge of and response to device failures and adverse events,” the letter said.
In the case of the intravaginal mesh, “we ask that the Committee seek documents from the manufacturers of surgical mesh to ascertain when they first learned of the safety issues associated with certain uses of the device and what, if any, actions they took to limit risks for patients.”
The lawmakers in the letter said holding hearings would provide important information for members to evaluate in the context of the reauthorization of medical device user fees, which are paid by device companies and help fund FDA, along with congressional appropriations.
“As the Committee approaches reauthorization of the Medical Device User Fee Act, we need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks,” the lawmakers wrote. “It is also vital that we understand whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous.”
The current legislative authority for the medical device user fee program, the Medical Device User Fee Amendments of 2007, will expire in September, and new legislation will be required for FDA to continue collecting user fees for the medical device program.
FDA was required to submit final recommendations to Congress by Jan. 15, but they were not submitted by that deadline.
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