The Food and Drug Administration convened a panel of experts Thursday, September 24, to review the device’s safety. The FDA is taking a closer glimpse at an assortment of issues reported with the permanent birth control implant which is termed as Essure.
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Essure consists of coils inserted into the fallopian tubes, where they are meant to spur scar tissue that eventually blocks sperm.
They are complaining about problems including severe pain, bleeding and weight gain. Many of those complaints have been shared through social media, including a Facebook page called Essure Problems, which has over 20,000 members. The news is cold comfort to those who wanted to see Essure pulled from the market, arguing the FDA failed to properly assess the medical device’s safety and efficacy and ignored the complaints of women over the years.
Ms. Hudak, of Lakewood, Ohio, said that within weeks of the implant, “I was in almost constant pain”, but said her doctor and nurse in the clinical trial told her this had nothing to do with Essure. Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients.
The Yale authors point out that the study looked only at women who had successful insertion of Essure, as confirmed by a test of their fallopian tubes three months after implantation.
“There were days when I could not get up out of the bed except to crawl to the bathroom in tears”, Rebecca Howell said to the panel. The number of complaints- ranging from persistent pelvic or abdominal pain to allergic reactions to the nickel in the device-have increased almost 20-fold since 2011 when only 115 complaints were filed.
The agency reported that “significant limitations would be taken care when reviewing the data” on the device.
The company admits that risks are involved with every medical device and procedure, but the highest priority for Bayer is the safety of the patient. “The hair loss was pretty devastating, I would say the worst part for me was my family was making memories without me, because I wasn’t able to participate in a lot of things because I was home sick”. In April, she says her symptoms became so severe she had to be rushed to the hospital where doctors told her the coils had lodged into her uterus.
While clinical trials generally prefer young healthy participants who are less likely to develop complications, the FDA required that women as old as 44 be represented in the Essure trial. “We also want to know what’s going on”, explains Dr. Patricia Carney, who is the medical director/women’s health at Bayer.
“It’s my expert option is that Essure is not a safe product”, he said.
newsnet5.com has been covering the stories of women who say they were seriously injured and harmed by the device for two years.
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Southern Med Law is investigating potential Essure side-effects lawsuits from women, or their loved ones, who believe they have suffered complications from the Essure birth control device, contact Southern Med Law to learn more about your legal rights.
