Denver, Colo., Jun 28, 2015 / 15:39 pm
After receiving thousands of complaints about the adverse effects of the birth control implant Essure, the FDA announced late Wednesday that it has updated the list of risks and complications associated with the device, and that a public hearing would be held Sept. 24 to evaluate the product.
Essure is a permanent type of birth control in the form of tiny metal coils inserted into women's Fallopian tubes. When the coils are implanted they are supposed to stay in the Fallopian tubes, where they create a chronic infection that will cause scar tissue to form around the coils, effectively closing the tubes and rendering the woman sterile.
Until this week, possible side effects of Essure listed on the product's website included: "mild to moderate pain and/or cramping, vaginal bleeding, and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting or fainting. In rare instances, an Essure insert may be expelled from the body."
Angela Desa-Lynch, an administrator for the Facebook group "Essure Problems", which protests the device, told CNA in February that the thousands of women in the group had experienced these problems to the extreme.
"Whatever they've put on the label, multiply it by 200," she told CNA in February.
At least five deaths of women, and five deaths of fetuses in women who've been implanted with Essure, have been reported. Other side effects many of the "Essure Problems" women have experienced include perforated organs, coils lodged in colons, fetal disfigurement due to nickel poisoning, chronic pain, exhaustion, bouts of depression, and suicidal thoughts.
The group, which grew from about 14,000 to over 18,000 just since February, seeks to inform and save every woman they can from getting Essure implants. In a statement on their website, the group said they feel encouraged by the FDA's announcement.
"We feel like the FDA has really been listening to us, to our group, and is taking some steps in the right direction to address the serious complications and problems with this device," it reads.
"Having a large government agency paying attention to a group of women harmed by a medical device, and making arrangements to review information and allowing our voices to be heard, is huge," the group said.
"We plan to bring with us as many of the original clinical trial participants as we can get there, along with our supporting physicians. We need every women harmed by Essure to get to this meeting. We need every media outlet there. All are welcome. Let's fill the room and pour into the hallways. Let your faces be seen, and let your pain serve a purpose. Not one more woman harmed by Essure."
The device was first manufactured by the group Conceptus and was pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.
In a statement released Thursday, Bayer said: "Patient safety is Bayer's top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure."
"Bayer is strongly committed to women having access to safe and effective birth control options. The only FDA-approved non-surgical option for women who have completed their families and want permanent contraception, Essure is supported by more than a decade of science and real world clinical experience."
The announcement by the FDA and the promise of the September meeting is a step forward for the Essure Problems group, which has enlisted the help of environmental lawyer Erin Brockovich (yes, that one) in a few pending lawsuits to get Essure taken off the market.
The end of the statement from the group, which refers to their fellow members as "E-sisters", reads: "Bound by pain, we will never stop until Essure is off the market."