More than 30 women contending that Essure, Bayer’s sterilization device mentioned above, caused them severe health problems, including abdominal cramping, migraines and abnormal menstrual bleeding, have filed one of the first Essure lawsuits against Bayer Corp. Some three dozen Plaintiffs have accused Bayer Corp. and Essure’s original manufacturer Conceptus Inc. – now a Bayer unit called Bayer Essure Inc. – of misleading federal regulators by downplaying patients’ reports of injuries allegedly caused by the Essure coils. The suit was filed on March 17 in Missouri state court and came before the FDA took action relating to the warning issue. The FDA, as I mentioned above in this issue, now requires Bayer to apply a “black box” warning to the devices.
The coil inserts, which comprise segments made of stainless steel and a nickel-titanium alloy, are implanted into both fallopian tubes, where they trigger tissue growth over time to block eggs from traveling to the uterus. The Plaintiffs claimed in their suit that from at least May 2014 to late January of this year, Bayer received more than 460 complaints about the coils breaking. In separate reports by Bayer to the FDA relating to the complaints, each of those events contained the allegedly misleading line that “single cases have been reported of Essure breakage, when in fact there are hundreds.” The Plaintiffs stated in their complaint:
Despite knowing about hundreds of instances of the Essure device breaking, Bayer has repeatedly reported to the FDA that only single cases exist. Therefore, when multiple FDA analysts read separate reports that each state ‘single cases have been reported of Essure breakage,’ it causes each individual analyst to falsely believe that instances of device breakage are extremely rare.
Essure, which the FDA approved in 2002, is a so-called class III medical device, which goes through a more rigorous approval process. The agency has said that as part of its requirements for granting pre-marketing approval for the device, it required Conceptus to continue studying it after the approval to determine long-term effects on its clinical trial patients and to assess how well new doctors were able to insert it.
The FDA has said that despite the more than 5,000 complaints on Essure it has received since its approval, it is still a compelling option since it is the only sterilization procedure for patients with wombs that doesn’t require any incision. The other sterlization process, known as tubal ligation, is a surgery that involves tying both fallopian tubes to prevent eggs from traveling from ovaries into the uterus.
The Plaintiffs are represented by Eric D. Holland and R. Seth Crompton of Holland Law Firm; Lewis O. Unglesby, Lance C. Unglesby, Jason R. Williams, Logan H. Greenberg, Nicole E. Burdett and Adrian M. Simm Jr. of Unglesby and Williams; Wells T. Watson, Jeffrey T. Gaughan and Zita M. Andrus of Baggett McCall Burgess Watson & Gaughan; and Richard J. Arsenault of Neblett Beard & Arsenault. The case is in the Circuit Court for the City of St. Louis, Missouri.
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