The FDA recently recommended a black box warning for the contraceptive Essure, calling attention to the potential for life-threatening and permanent health problems. The agency also ordered Bayer, Essure’s manufacturer, to conduct a new study on the implantâ’s true risks. The Essure lawyers at Pintas & Mullins Law Firm are disappointed in the FDAs failure to protect women from further harm.
Essure is a non-invasive form of permanent birth control approved in 2002. The device is implanted into a woman’s fallopian tubes, causing scar tissue to grow around the device to prevent sperm from reaching eggs, thereby preventing pregnancy.
Essure vs. Tubal Ligation
The device was heavily marketed to busy women €œon-the-go who wanted a permanent form of birth control without having to undergo surgery. Unlike traditional tubal ligation (or having your €œtubes tied,€) implanting Essure does not require surgical incisions. Doctors simply insert the Essure system in-office, through the vagina and cervix and into the fallopian tubes, and patients can return home immediately after.
Women then must wait three months for scar tissue to grow around the Essure coils, ultimately blocking the fallopian tubes. During those three months, and at any point after, women can experience any number of complications and side effects. There have been thousands of reports of irregular bleeding, allergic reactions, pain, organ perforation, unintended pregnancy, and device migration.
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For decades, all women who wanted permanent birth control underwent surgical bilateral tubal ligation (BTL), which is an invasive procedure. During BTL, the patient receives general anesthesia and doctors cut, block or close the fallopian tubes to permanently prevent pregnancy. Sterilization is therefore immediate, safe, effective, and requires little to no follow-up. The only risks associated with BTL are those related to general anesthesia, possible organ injury, and bleeding.
Unfortunately, Essure is the only non-invasive permanent birth control device available in the country. Because of this, the FDA is allowing Bayer to keep Essure on market, even as reports of serious and permanent injury mount and more and more women file suit against Bayer.
New Warnings, New Study
In light of the growing number of complications from Essure, the FDA convened a meeting to hear expert medical and scientific opinions, as well as real stories from real patients. At this meeting in September 2015 it became clear that many women are not receiving or understanding the risks and benefits of Essure.
Rather than taking the device off market, the FDA recommended that Essureâ’s labels change to include a black box warning and a patient decision checklist. The
FDA failed to actually impose this label change, however, saying it wanted to hear public opinion before requiring label changes. Apparently, more than 5,000 patient injury reports and four deaths are not enough.
Bayer is also required to conduct a new study following 2,000 patients over the next three years. The study will compare women implanted with Essure with women who chose other sterilization methods, such as BTL.
From Congressmen to Erin Brockovich
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Many people across the nation are outraged over the FDAs failure to take any significant measures against Essure. Not only did it take more than a decade for the FDA to respond at all, but the minor actions it did make are not enforceable; and it will take years for Bayer’s study to come to any type of conclusion. How many more women will be harmed during that time?
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Pennsylvania Representative Mike Fitzpatrick has called for the FDA to revoke Essure’s approval, along with a former FDA contractor. The two men compiled raw data showing more than 300 fetal deaths among women implanted with Essure, and tens of thousands of injury reports. Fitzpatrick plans to introduce new legislation in the House and Senate that would offer protections for women injured by Essure, among other goals.
Because the FDA has failed to protect the public, advocates are now calling on Congress to act. Erin Brockovich praises the women who have stepped forward and told their stories in public FDA forums, websites, and community groups as well. She states that, as a direct result of these womenâ’s actions, important information on the FDA and its inadequate policies have come to light.
Our team of Essure lawyers currently accepting cases of serious injury from this device. We accept clients nationwide, and work only on contingency-fee basis, so our clients never pay anything out-of-pocket. Call our team of compassionate, skilled, and experienced medical device lawyers for a free case review.
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