U.S. Representative Michael Fitzpatrick of Pennsylvania has introduced a new bill that directs the Food and Drug Administration (FDA) to withdraw Bayer’s Essure birth control implant from the market.
The safety of the implantable device—a permanent birth control method—has been called into question. In September, the FDA held an advisory panel meeting to hear expert opinion about the device and reports from women about their experiences with Essure, the Regulatory Affairs Professionals Society (RAPS) reports. Rep. Rosa DeLauro of Connecticut wrote to the FDA last month requesting the agency to withdraw Essure because its “benefits do not outweigh its risks.”
Fitzpatrick’s bill, known as the “E-Free Act,” would require the FDA to withdraw approval of Essure no later than 60 days after the bill’s enactment. In announcing the bill, Fitzpatrick said that since the device appeared on the market in 2002, the FDA has received more than 5,000 complaints, RAPS reports. “Furthermore, the product is responsible for deaths of four women and five unborn children,” Fitzpatrick said in a statement. “If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”
Essure is marketed as a surgery-free alternative to standard laparoscopic sterilization surgery, which is done with a small incision. Essure consists of a small pair of metal coils that are inserted into the fallopian tubes to create scar tissue that blocks the tubes and prevents pregnancy, RAPS explains. Essure is implanted through the vagina, in a procedure in a doctor’s office. Since Essure came on the market, thousands of women have reported problems with Essure, ranging from metal allergies to severe abdominal pain, to organ perforation, and unplanned pregnancies, including ectopic pregnancy, which can be life threatening.
In 2013, the FDA reviewed Essure’s safety based on the available literature and adverse event reports, RAPS reports. At that time, the FDA concluded that Essure was an effective alternative to surgical sterilization and that its risks were rare and were described in the device’s labeling. The FDA acknowledges the deaths reportedly linked to Essure, but cautions that it is difficult to confirm “whether a device actually caused a specific event … based solely on the information in a given report.”
The FDA panel that met in September called on the agency to update Essure’s label and require additional postmarket studies on the device. The panel also said ongoing trials should be reviewed to determine if “data could be collected to address some of the topics of concern,” and more data is needed on potential allergic reactions or sensitivities to the metals used in the device, according to RAPS.
The FDA panel said Essure should remain an option, especially for “women who are not good candidates for laparoscopic or general surgery.” Additionally, the panel recommended patients with “hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, and those with a history of abnormal uterine bleeding” consider other options for permanent sterilization.