House Democrats called for congressional hearings on a gastric band made by Allergan Inc. (AGN) and transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients.
U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said today in a statement.
The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries. The Democrats said studies also showed high rates of complications with the Lap-Band made by Allergan.
“The committee should 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,” Democrats said in a letter to the Republicans today. “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 Democrats cited a study, published this week in the medical journal Archives of Surgery, that found almost half of patients with a gastric band had no weight loss or needed the device removed after six years. More than 40 percent had long- term complications, the letter said.
The study used an older band and an older surgical technique, said Naziah Lasi-Tejani, a spokeswoman for Irvine, California-based Allergan, in a telephone interview. Using a newer version and updated techniques, the rate of patients needing a follow-up operation is three times lower, she said.
Complication rates in the study were also “significantly higher” than what Allergan (AGN) has seen in clinical practice, suggesting doctor training is key, Lasi-Tejani said.
Matthew Johnson, a J&J spokesman, didn’t return a message seeking comment.
Congress has until October to reauthorize a law that funds the FDA’s review of new products. House Republicans’ hearings so far threaten to give a “skewed” portrait of the situation, the Democrats said in today’s letter. They said Republicans still haven’t responded to an October request to hold a hearing on artificial hips and implanted brain stents that have also raised safety concerns.
The Energy and Commerce Committee is “thoroughly examining” device rules and plans another hearing on Feb. 15, said Debbee Keller, a spokeswoman for the committee’s Republican majority. She didn’t give specifics on the hearing’s agenda.
“Both the majority and minority have selected witnesses to testify, bringing patients, innovators, investors, job creators, and administration officials before the committee in the last several months,” Keller said in an e-mail. “Members on both sides of the aisle agree the status quo is unacceptable.”
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