WASHINGTON (MEDIA GENERAL) – A medical device designed to offer women pain-free permanent birth control has been accused of creating adverse side effects for thousands of users.
Essure, an implant sold by Bayer Pharmaceuticals, is a non-surgical procedure intended to allow women to have sex without the risk of pregnancy. While the device has been on the market since 2002, an estimated 5,000 women have raised concerns to the Food and Drug Administration about side effects from the product’s use.
“The doctors will tell you that the side effects are rare, but the side effects are debilitating,” said Krystal Donahue, a mother in suburban Maryland who is urging women to be more aware of potential consequences.
How it works
Essure works by using two small nickel based coils to create a natural barrier to sperm in a woman’s Fallopian tubes. The implants are designed to be implanted without the need for painful or invasive surgery. Essure’s maker markets the device as 99% effective at permanently preventing pregnancy and reports at least 750,000 women have used the product worldwide.
First success, then concerns
Three months after Essure is implanted, patients are expected to follow up with a medical check-up to determine if the devices are properly placed. The effectiveness test can be conducted via ultrasound or through a x-ray where dye is used to determine the location of the implant.
For Ms. Donahue the first few days passed without any major complications. However, within a few months she complained of exhaustion, severe pain, and an inability to have a normal routine.
“I had painful sex, constant pain in my side,” added Ms. Donahue when asked to describe what conditions were like following Essure’s placement.
Through social media pages and topic specific websites, other users discuss similar complications and a wide range of side effects from allergic reactions to joint pain.
“We know there are a number of women who’ve reported these symptoms, in the contexts of the total number of implants that have been placed it’s a small number,” said Dr. Patricia Carney, director of Women’s Health at Bayer Healthcare’s U.S. Medical Affairs unit.
From controversy to Congress
After hearing from constituents about complications from Essure, one Pennsylvania congressman is turning his attention to the government agency in charge of regulating medical implants.
“I think it’s disappointing the FDA hasn’t acted,” said Rep. Mike Fitzpatrick (R-Pennsylvania) during an interview regarding Essure’s current status as approved by the Food and Drug Administration. In an effort to push the government agency to pull Essure off the market, Rep. Fitzpatrick introduced legislation in the fall of 2015 dubbed the “E-Free act.” The measure would require the FDA to immediately pull Essure’s status.
For its part, the Food and Drug Administration has conducted reviews of Essure’s effectiveness but as recently as early 2016 continued to uphold the decision to keep Essure on the market.
“Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency” said a spokesperson for the agency via an electronic statement.
In March, the agency announced plans to require a new warning label on Essure’s packaging to alert women to potential side-effects they might not have otherwise been aware of.