Essure Victims Not Assured—Yet

Washington, DCThe FDA is finally responding to more than 5,000 women and congresswoman Rosa DeLauro about Essure adverse events. The agency is expected to decide whether or not to withdraw Essure from the market by the end of this month.

Meanwhile, Essure lawsuits filed against Bayer by four women have been dismissed this month. A federal judge in California ruled that plaintiff Tanya De La Paz’s state-law claims against Bayer for design and manufacturing defect, failure to warn, fraud and breach of warranty, among others, were preempted by federal law, according to Reuters (Feb. 4 and Feb. 8, 2016). However, Judge William Alsup said that plaintiff Tanya De La Paz could amend her complaint if she could address certain shortcomings in the original, Case No. 3:15-cv-03995.

Increasingly, evidence indicates that Bayer was aware of Essure adverse events before its sterilization device was granted FDA premarket approval in 2002, which means the process is subject to certain conditions. These conditions include regular reporting on efficacy, reporting of all adverse events, and seeking approval for any change to the device.

De La Paz had the Essure implanted in July 2012, but the procedure was abandoned after the device perforated one of De La Paz’s fallopian tubes. In February 2013, De La Paz underwent surgery to have her right fallopian tube removed along with the broken micro-insert that had anchored there, which she had been informed would relieve her symptoms. Again in September 2015, De La Paz underwent surgery to have the micro-insert in her left fallopian tube removed.

According to De La Paz’s complaint:

“Bayer received several Form 483s, which are reports written by FDA investigators revealing potential violations discovered during an inspection of a manufacturing facility. Specifically, in June 2008, Bayer received a Form 483 that indicated that since 2005, it had been “manufacturing medical devices . . . at an unlicensed facility,” that it had “failed to maintain procedures to control documents” relating to the maintenance of pre-sterile and post-sterile quarantine cages, and that its facility “no longer use[d] pre-sterile and post-sterile cages”

Her claims against Bayer include design and manufacturing defect, failure to warn, fraud and breach of warranty. The FDA said that Essure “is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communicating our actions publically at the end of February 2016.” Stay tuned...