Essure Complication Complaints Doubled Since November: Report
An increasing number of women and their doctors are complaining to the FDA about complications from Essure birth control, with many indicating the implants caused pain, bloating, and other problems where it migrated to other areas of the body.
According to an investigative report by KATU, a Portland, Oregon news station, the FDA has received at least 2,049 adverse event reports involving Essure complications as of March.
These numbers are up from just 850 complaints received by U.S. health regulators between the launch of the birth control implant in 2004 and October 2013, when Bayer updated the label warnings provided with their product to include mention of complications involving abdominal pain and device migration.
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Learn MoreEssure birth control was first approved by the FDA in 2002. It was originally designed and manufactured by Conceptus, before recently acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.
The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
Complaints Led to Essure Concerns
In recent months there have been increasing concerns about the potential side effects of Essure birth control, following the report of at least one death last year and protests by women who have experienced complications, including the launch of a webpage launched by the prominent activist Erin Brockovich.
In October, the FDA released the results of their own investigation into Essure, finding that the complications, for the most part, were known during clinical trials, including the risk of pain and migration. However, the agency did note that some of the complaints, including depression, extreme fatigue, and weight gain, were not seen during the clinical trials.
The agency concluded that the benefits outweighed the risk of Essure injuries and decided to leave the device on the market. However, the agency has indicated that it will continue to monitor the complaints and reports of problems.
Among complaints submitted to the FDA are indications that women suffered intense abdominal pain and other problems. In some cases, doctors have reported seeing Essure devices migrate out of the fallopian tubes, perforating other organs and sometimes breaking. There are even cases of pregnancies alongside the devices, which are supposed to prevent them.
Experts who reference the FDA’s adverse event reporting program say that while it is imperfect, and does not establish a cause-and-effect relationship, reports are routinely very low, with possibly only one out of every 10 adverse events associated with a device reported to the agency.
Bayer has stressed that Essure should not be judged on the adverse events alone. The company states that the complaints being heard are the rare side effects that were already known to be associated with the device and say that it is more than 99% effective. The company also claims that the complaints represent just a fraction of the 750,000 devices sold worldwide.
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4 Comments
CherylSeptember 23, 2015 at 11:26 pm
December 2013 I under went sugery for a hysteroscopy d&c ablation with the placement of essure coils. There was a malfunction of the essure product which resulted in 3 coils placed on the left side. There seemed to be no concern at the time since they seemed to be lined up in the falopian tube. Knowit takes roughly 3 months for scar tissue to form around the coils I figured the pelvic pain would s[Show More]December 2013 I under went sugery for a hysteroscopy d&c ablation with the placement of essure coils. There was a malfunction of the essure product which resulted in 3 coils placed on the left side. There seemed to be no concern at the time since they seemed to be lined up in the falopian tube. Knowit takes roughly 3 months for scar tissue to form around the coils I figured the pelvic pain would subside. It did not. I put going back to doctor until October 2014. I was sent to pelvic floor physical therapy, did not help. I had another surgery to have the coils removed March 12th 2014. The first thing that was said to me in the recovery room by my surgeon was "no wonder you have been in so much pain" two of the coils had migrated out of the tube which laued up against my bowel. The 3rd had penetrated sideways through the tube. Both of my falopian tubes were removed. This was one thing I did not want to happen.
AmyNovember 19, 2014 at 3:01 am
wow...guess I do live a sheltered life... I'm 50. I've had Essure Birth Control for 4 years now. I cant believe what im reading,,, it explains why I feel like I do ....why my body has been d
candaceNovember 8, 2014 at 4:24 pm
I REALLY WISH THEY WOULD LISTEN TO US WOMAN..WE KNOW WHAT OUR BODY IS GOING THROUGH.I AM DOING EVERYTHING I CAN IN MY LOCAL AREA TO SPREAD AWARENESS ABOUT THIS PRODUCT THAT BAYER CONTINUES TO PUT ON THE MARKET AND IMPLANT IN WOMAN.WE ARE MOMS AND WE WANT TO ENJOY OUR CHILDREN.I CAN'T EVEN GET UP MOST DAYS BECAUSE OF THE ADVERSE EFFECTS THAT ESSURE HAS PUT ME THROUGH AND NO ONE DESERVES TO GO THROU[Show More]I REALLY WISH THEY WOULD LISTEN TO US WOMAN..WE KNOW WHAT OUR BODY IS GOING THROUGH.I AM DOING EVERYTHING I CAN IN MY LOCAL AREA TO SPREAD AWARENESS ABOUT THIS PRODUCT THAT BAYER CONTINUES TO PUT ON THE MARKET AND IMPLANT IN WOMAN.WE ARE MOMS AND WE WANT TO ENJOY OUR CHILDREN.I CAN'T EVEN GET UP MOST DAYS BECAUSE OF THE ADVERSE EFFECTS THAT ESSURE HAS PUT ME THROUGH AND NO ONE DESERVES TO GO THROUGH E HELL AND I WILL KEEP SPREADING THE WORD..
RachaelApril 22, 2014 at 6:56 pm
I think Bayer needs to stop hiding and show their true results. There are way to any women have to have hysterectomies before their 30 because of this device. This needs to be taken off the market. Further more they are admitting to knowing that this would happen yet they are still allowed to market essure. Thank you the FDA for approving this wonderful form of birth control. I am thirty and [Show More]I think Bayer needs to stop hiding and show their true results. There are way to any women have to have hysterectomies before their 30 because of this device. This needs to be taken off the market. Further more they are admitting to knowing that this would happen yet they are still allowed to market essure. Thank you the FDA for approving this wonderful form of birth control. I am thirty and will be without my tubes possibly my uterus. I think that maybe instead of worrying about how much money you'll have in your pocket you should be thinking about the health of women using this product.