Efforts to remove Bayer’s implantable contraceptive Essure from the market continue to mount, with the introduction of a House bill that would require the FDA to withdraw premarket approval of the device.
H.R. 3920, The E-Free Act, was introduced by Michael Fitzpatrick (R-Pa.) on Nov. 4 and is co-sponsored by Reps. Marsha Blackburn (R-Tenn.), Christopher Smith (R-N.J.) and nonvoting member Gregorio Sablan (I-N. Mariana Islands). The bill was referred to the House Energy and Commerce Committee that same day.
The move has been met with applause from stakeholders. For example, Diana Zuckerman, president of the National Center for Health Research, says the introduction of H.R. 3920 shows that some members of Congress wondering why the FDA has lowered its scientific standards, and are pushing the agency to do a better job of protecting patients.
“Our research shows that Essure is much more dangerous than was shown in the data provided to the FDA — data that are still on the FDA website,” Zuckerman tells IDDM. That information, she adds, misleads patients, many of whom have been harmed by the implant.
The FDA never should have approved Essure based on a study with no comparison group of women using a different type of long-term or permanent contraception, says Zuckerman. Further, the company’s studies of Essure were conducted in a way that covered up terrible complications reported by patients.
Bayer, which acquired Essure when it bought Conceptus in 2013, has acknowledged that there are risks associated with the device, but insisted the implant has helped many women.