U.S. Rep. Mike Fitzpatrick of Pennsylvania says he plans to introduce a bipartisan bill to Congress to ban the Bayer HealthCare contraceptive Essure because of reports the device has caused hundreds of women pain and suffering.
“The Essure device is harming women and needs to be removed from the market,” he said in a prepared statement. “I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”
Essure is a flexible, nickel-titanium coil that is inserted into the fallopian tubes where the inserts work with the body to form a natural barrier that keeps sperm from reaching the egg, thus preventing pregnancy. The device was approved by the Food and Drug Administration (FDA) in 2002, and remains the only FDA-approved non-surgical permanent birth control method.
Since the device was approved, about 20,000 complaints have been gathered from a Facebook group, Essure Problems. The page has about 17,000 members who claim to have suffered Essure side effects.
Complaints range from heavy bleeding and chronic pain to metallic taste in the mouth; itching, tingling arms and legs; confusion; hair loss; and teeth loss. One woman claims a hysterectomy was the only cure for the flu-like symptoms she suffered from the contraceptive.
The device’s website lists other side effects including the risk of the insert expelling from the body or migrating from its intended position in the fallopian tubes into the lower abdomen and pelvic region, in which case surgery is required for removal. If pregnancy occurs after the device is inserted, it would most likely be ectopic, which can be life threatening.
In September, the FDA announced it was holding a safety review on Essure based on a “dramatic increase” in complaints involving the device. The agency has yet to offer any recommendations from that review.
Rep. Fitzpatrick says he will introduce the bill on Nov. 4, which is the 13th anniversary of Essure receiving premarket approval from the FDA.