The United States Food and Drug Administration will examine the new birth control implant "Essure" after complaints of nasty side effects began flooding in.
Investigators from the United States Food and Drug Administration will examine a growing list of health problems associated with the birth control implant product “Essure.” According to a report from the Huffington Post, the product has been linked to side effects including chronic pain, headaches, bleeding, and allergic reactions.
The FDA posted a 90-page online review of the birth control implant this Monday in preparation for a meeting Thursday where a panel of experts will discuss the safety and efficacy of the implant. The product has been available for 13 years, but the FDA has been receiving complaints about the associated side effects since 2013.
The device is marketed as one of the only permanent birth control implants that doesn’t need to be administered surgically. It consists of two small, metallic coils that are implanted into the fallopian tubes where they precipitate the growth of scar tissue that blocks sperm attempting to reach any eggs before they can be fertilized. The company that manufactures the product, Bayer, markets it as an alternative to the traditional surgical procedure of having one’s tubes “tied.” The warning label lists a number of risks and side effects, like short-term pain and bleeding following the insertion procedure. The label also warns that the device can become dislodged and migrate into the lower abdomen or pelvis. This would require surgery to fix.
The label also lists the risk of allergic reaction to the material the product is made from, a nickel-titanium alloy.
The label may not tell the whole story, however. Thousands of submitted complaints include chronic pain, fatigue, weight gain and depression. Many accounts of the unlisted side effects have surfaced on social media, and there is even a Facebook page called “Essure Problems” that currently has over 20,000 members.
The FDA has called on health experts to discuss the conflicting information about the safety of Essure. Manufacturer-backed studies claim that chronic pain and other recurring health problems are rare, but the patients who actually use the product tell a different story. There were over 20,000 different mentions of problems related to the birth control implant, the majority of them pulled from Twitter.
Kim Hudak, a 43-year-old Essure patient, says that she hopes the FDA meeting will lead to the product being pulled from the market. She had the implant removed in 2013 after suffering years of pain, fatigue, and other symptoms that she believes were caused by Essure. “I’m hopeful that at least the doctors on the panel will listen with an open mind and hear what’s being said, because there’s a lot of very damaged women out there,” she said.
German drug company Bayer says that the label is consistent with the actual risks posed by the product. This claim is based off of internal research. According to Bayer’s vice president for women’s health, Edio Zampaglione, “Our hearts do go out to any woman who has experienced an adverse event with any one of our products. But what we are seeing in all of this is that the events are consistent with what was seen in the clinical trials.”
The panel will try and determine whether or not it is in the best interest of women’s health to restrict or ban the device. First, they will need to address the claims of extraordinary side effects, and from there can go on to decide how the implant should be treated moving forward.