Essure birth control devices may cause “serious or life-threatening” complications in some women, according to a new United States Food and Drug Administration warning. Although the agency will require new warning labels and further investigation into the safety concerns, the product will remain on the market until further notice.
Essure devices are a permanent form of birth control, which were approved by the FDA in 2002. Although they are advertised as safe and effective, thousands of women have lodged complaints about the product.
Each Essure device contains a flexible metal coil, which is inserted into the fallopian tube to encourage the growth of scar tissue. Within approximately three months, the tissue forms a natural barrier, which prevents sperm from entering the fallopian tubes and fertilizing an egg.
Essure devices are specifically appealing, as the non-surgical procedure can be performed in a doctor’s office and the devices do not contain any hormones.
Although the FDA will increase Essure warnings, they contend “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.” Unfortunately, thousands of women have reported serious complications.
New, stronger FDA warning for Essure birth control implant: https://t.co/El2OJWnGiA pic.twitter.com/VUM0ndWMOd
— ABC 7 Chicago (@ABC7Chicago) March 1, 2016
According to the Manufacturer and User Facility Device Experience database, nearly 10,000 women reported complications with Essure birth control devices. Although a majority of the complaints were related to abdominal pain, menstrual irregularities, headache, fatigue, and weight loss or gain, others were far more serious.
The serious complaints included more than 1,200 reports of device breakage and migration and at least 26 deaths. The FDA also confirmed at least 631 women became pregnant while using the device.
CNN reports the FDA will require a “black box warning” for all Essure devices, in an effort to raise awareness about possible complications. However, the agency stopped short of declaring the product misbranded.
In addition to the new warning labels on Essure boxes, the FDA is requiring Bayer to “conduct a new postmarket surveillance study,” within the next 15 months.
“Bayer will be required to develop and conduct a post-market study that will provide data to help the agency to better understand the risks associated with Essure… This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life.”
At the conclusion of the study, the FDA will evaluate the results to determine whether any further action is needed. However, critics are arguing for an immediate recall.
Pennsylvania Rep. Mike Fitzpatrick said the FDA already has enough evidence to revoke the approval and to recall the birth control devices.
“It’s unbelievable… It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”
Women who claim they were harmed as a result of using an Essure device have joined forces on numerous websites and social media platforms.
A Facebook page titled Essure Problems currently has more than 10,000 “Likes.” Healthcare practitioners and women who have suffered complications with the product are encouraged to share their personal stories in an effort to share support and raise awareness.
— Kerri O’Brien (@Kerri8News) February 28, 2016
EssureProblems.com also offers information about the birth control device and support to those who have suffered complications. In a February 29 press release, the site’s administrators said they are “disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”
Although the FDA will require more warning labels on Essure birth control devices, they will remain on the market until the agency deems the product unsafe.
[Image via Faviana Ponzi/Shutterstock]