A Pennsylvania congressman has introduced a federal bill to revoke the Food and Drug Administration’s approval for a contraceptive that has been the subject of thousands of complaints from women.
Essure, an implantable birth control device, was approved by the FDA in 2002. Since then, more than 5,000 people have made official reports of adverse events related to the device to the FDA, and more than 20,000 people have joined a Facebook page documenting health problems they say are caused by the contraceptive.
“This is a country that is supposed to protect women, and in this case it failed in doing so,” said Rep. Michael Fitzpatrick (R-Doylestown), who sponsored the E-Free Act, which would direct the FDA to withdraw premarket approval for Essure.
Fitzpatrick said he was persuaded to draft the legislation after women, including some of his own constituents, told him stories of their pain and suffering after being implanted with Essure.
Over the past two years, the I-Team has uncovered problems with the clinical trial research that led to Essure’s pre-market approval, or PMA for short. In some cases, clinical trial participants reported severe and constant pain after being implanted, but researchers marked their comfort level as “excellent” or “very good.”
“The FDA can act on its own,” Fitzpatrick said. “If it has bad data, go back and revoke the PMA approval. Take it off the market and carefully and methodically, slowly if necessary, go back through the approval process to find out what went wrong.”
The Essure system consists of two coils made of nickel and titanium which are implanted into the fallopian tubes. After a period of time, the coils create enough scar tissue to block conception and pregnancy.
A company called Conceptus invented the device and conducted the clinical trials. In 2013, Bayer purchased Conceptus and became the manufacturer of Essure.
In September, members of the FDA Obstetrics and Gynecology Panel questioned Bayer officials about why more research hasn’t been done on whether nickel in the Essure coils is causing allergic reactions. The panel recommended more research, but stopped short of asking for the birth control device to be pulled off the market.
Rosemarie Yancosek, a Bayer spokeswoman, said the company stands behind Essure because its risk benefit profile remains positive.
“It is critical that the scientific data driven process already in place at FDA continues to guide the path forward. Bayer is committed to working with the FDA as it considers the Panel’s advice,” Yancosek wrote in an email to the I-Team.
Deborah Kotz, an FDA spokeswoman said the agency would not make a statement about the E-Free Act.
"As per our usual policy, FDA does not comment on proposed legislation," she said.