The U.S. Food and Drug Administration (FDA) approved new labeling on Essure permanent birth control devices to include a boxed warning of adverse risks and a patient checklist.
The label change on the box will include language warning women that some patients have experienced perforation of the uterus and fallopian tubes, device migration, allergic reactions, pain, and other negative reactions.
“Among other changes, Bayer, the company that makes Essure, will include a boxed warning and patient decision checklist in the labeling to help ensure that women receive and understand the benefits and risks of these permanent birth control devices,” said the FDA.
The changes came about after more than 5,000 complaints to the FDA over 13 years prompted the regulatory committee to hold a meeting with experts from the medical community in 2015. After hearing testimony from women and gathering more data, the FDA concluded that women weren’t receiving proper information regarding risks.
Bayer will release the final wording of the new label on its website within 30 days.
Changes Come in Light of Essure Lawsuits
The Essure labeling change comes in light of allegations from women claiming that the permanent birth control device has caused severe complications like uterine perforation and persistent pain.
Heather Walsh was one of the first women to bring a lawsuit against the pharmaceutical giant. During the initial Essure implantation in her fallopian tubes, a representative from Bayer was supposed to supervise the physician on the procedure. According to the legal documents, the representative did not attend and the physician was unable to successfully implant the device.
At the second visit, the Bayer representation once again failed to show, but the implantation was made successfully after a few failed attempts. Complications arose not long after.
“After two years, Plaintiff was then hospitalized four times due to severe pain, fever, and fainting spells,” said the court documents about Walsh’s history. “Eventually a CT scan revealed that one of the micro-inserts had migrated from the fallopian tube and became lodged in or behind her colon.”
By March 2013, Walsh had to undergo a complete hysterectomy and surgery to remove the Essure device. She now suffers from a number of autoimmune and adhesion disorders. She filed a lawsuit on the basis that Bayer failed to warn her of the risks associated with Essure.
Walsh’s lawsuit is not unlike hundreds of others filed against Bayer.
Essure Lawsuits Receive Key Victories Earlier This Year
Women with Essure lawsuits against Bayer have received encouraging news from courts over the last year.
In March, U.S. District Judge John R. Padova of the Eastern District of Pennsylvania allowed five cases against Bayer to proceed. Although the judge threw out a number of counts, he allowed the cases to continue under claims of negligent risk management, breach of warranty, fraudulent manufacture, and more.
Then, in August, a judge in California allowed 11 consolidated cases to continue with failure to warn claims. Judge Winifred Y. Smith in Superior Court of California rejected Bayer’s request for immunity.
“Bayer, like many other drug and medical device manufacturers, has been trying to use the doctrine of Preemption to immunize itself from liability and deny women alleging injury by its product their day in court,” said attorney Lou Bograd in a statement. “In the Essure litigation, we are prepared to tackle all legal hurdles Bayer throws at us and to continue working toward allowing our clients to be heard.”
Both of these rulings bode well for other women considering a lawsuit against the pharmaceutical company for a failure to warn and negligence.
New FDA Changes Don’t Go Far Enough, Critics Say
Even in light of legal actions and the new FDA guidelines on Essure, critics say that more needs to be done.
Congressman Mike Fitzpatrick, who sponsored a bill last year that would outright ban the sale of Essure in the United States, released a statement on the FDA’s recommendations.
“A year ago, I introduced the E-Free Act to revoke FDA approval of Essure and prevent government agencies from purchasing this device considered to be unsafe,” said Rep. Fitzpatrick in a statement from his office. “Since then, hundreds of women affected by Essure have shared their stories with my office. And I believe now, as I believed then, if the FDA will not act to protect these women, then Congress must act now.”