The safety of Essure-a permanent nonsurgical birth control method-has been called into question. Representative Michael Fitzpatrick of Pennsylvania has introduced legislation that would require the Food and Drug Administration (FDA) to withdraw market approval for Bayer’s Essure birth control implant.
The safety of Essure-a permanent nonsurgical birth control method-has been called into question. Since Essure came on the market in 2002, the FDA has received more than 5,000 complaints of adverse events.
In September, an FDA advisory panel heard reports from medical and scientific experts and women who had been implanted with Essure told the panel their experiences, the Regulatory Affairs Professionals Society (RAPS) reports. In a separate action, Rep. Rosa DeLauro wrote to the acting commissioner of the FDA to request that the agency withdraw Essure because its “benefits do not outweigh its risks.”
FDA to withdraw approval of Essure within 60 days of the bill’s enactment
Fitzpatrick’s bill, known as the “E-Free Act,” would require the FDA to withdraw approval of Essure within 60 days of the bill’s enactment. In announcing the bill, Fitzpatrick noted the adverse event reports to the FDA and said, “the product is responsible for deaths of four women and five unborn children.”
In his statement, Fitzpatrick said, “If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”
Essure is marketed as a nonsurgical alternative to standard laparoscopic sterilization surgery which is done via a small incision. Essure consists of a pair of flexible metal coils that are inserted into the fallopian tubes through the vagina.
The coils create scar tissue that blocks the tubes and prevents pregnancy, RAPS explains. Essure is implanted a procedure in a doctor’s office. Since Essure came on the market, thousands of women have reported problems including metal allergies, severe abdominal pain, organ perforation, unplanned pregnancies, and ectopic pregnancies, which can be life threatening.
In 2013, the FDA conducted a review of Essure’s safety using the available literature and adverse event reports, RAPS reports. At that time, the agency concluded that Essure was an effective alternative to surgical sterilization and that its risks were rare and were adequately described in the labeling.
While the FDA acknowledges the deaths reportedly linked to Essure, the agency notes that it is difficult to confirm “whether a device actually caused a specific event … based solely on the information in a given report.”
FDA panel called on the agency to update Essure’s label and to require additional postmarket studies of the device
After its meeting, the FDA panel called on the agency to update Essure’s label and to require additional postmarket studies of 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.”
The panel said more data is needed for potential allergic reactions or sensitivities to the metals used in the coils, according to RAPS.
The panel said Essure should remain available, especially for “women who are not good candidates for laparoscopic or general surgery.” But the panel said women with “hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease, and those with a history of abnormal uterine bleeding” should choose another option for permanent sterilization.