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Nov. 4 — The FDA would be forced to pull its approval for a Bayer AG birth control device under a bill (H.R. 3920) introduced by a Republican lawmaker Nov. 4.
Rep. Michael G. Fitzpatrick (R-Pa.) sponsored the E-Free Act, which would revoke the Food and Drug Administration's premarket approval (PMA) of Bayer's Essure medical device.
A PMA is filed typically for high risk, or class III devices, and requires a demonstration that a device is safe and effective, often through clinical data. Essure is a permanent female sterilization device, with a nickel-based metal coil designed to be inserted in the fallopian tube. The FDA approved the device in 2002.
William A. Garvin, an attorney who specializes in device and drug approval issues at Buchanan Ingersoll & Rooney PC in Washington, told Bloomberg BNA in a Nov. 4 e-mail that the FDA is in a much better position to review the studies supporting whether a device is safe and effective than Congress.
Garvin said that ideally, patient groups would work within the FDA system to have the agency re-review the safety and efficacy of devices and even remove approval of a device if needed.
“Many drugs and devices come with risks of serious injury or even death, but that does not mean that these products should always be barred from the market in all cases,” Garvin said. “I do think this bill is indicative of patient groups being more willing to bring Congressional pressure on FDA when they feel like their concerns are falling on deaf ears.”
A bill summary from Fitzpatrick's office said the FDA has received over 5,000 formal complaints related to Essure. The device has caused the deaths of four women as well as five fetal deaths in women who became pregnant after the device was placed, Fitzpatrick's summary said.
Moreover, tens of thousands of others reported other symptoms, including extreme pelvic and abdominal pain, bleeding, migraines, allergic and hypersensitivity reactions to nickel, autoimmune reactions, loss of teeth and hair, the metal coil breaking and migrating throughout the body and the coil cutting into the uterus and other organs in the abdominal cavity, according to the summary.
In September, an FDA advisory panel said Bayer should do more studies on Essure to better determine causes of pain and other severe side effects.
Responding to a request to comment on Fitzpatrick's legislation, a Bayer spokewoman provided a statement to Bloomberg BNA that said the company stands by the positive benefit-risk profile of Essure. The product “ is an important option for women who have completed their families and want a permanent form of birth control,” the statement said.
Furthermore, Essure's safety and efficacy “is supported by more than a decade of science, as well as real world clinical experience—with the product having been studied with more than 10,000 women since it was first developed,” Bayer said.
The FDA recently held a meeting of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee to discuss the benefits and risks of Essure, Bayer's statement said, adding, “It is critical that the scientific, data driven process already in place at FDA continues to guide the path forward.”
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