It is possible that Unglesby’s “thousand” is a conservative estimate because some women who have Essure complications aren’t necessarily associating their injury with the device.
“Bayer not only deceived these women but also their physicians,” explains Unglesby.“Doctors and patients weren’t armed with the same data that Bayer had. Now that the FDA has suggested a black box warning, physicians are going to be able to accurately diagnose symptoms as being associated with the Essure device. I know a lot of gynecologists who have stopped using Essure as a result of the FDA’s suggested boxed warning.”
The FDA also requires a Patient Decision Checklist to help ensure that women receive and understand information regarding the benefits and risks of this type of device. The mandatory box warning on the product must explain the adverse events that have been associated with these devices, including their insertion and/or removal procedures. But this warning has come too late for many women who have been injured by Essure.
Essure side effects
“Women have reported heavy bleeding [some have required blood transfusions], constant heavy bleeding, dyspareunia or painful sexual intercourse, chronic pelvic pain, chronic fatigue and hair loss,” says Unglesby. “And if the coil breaks apart and migrates, some women have required serious emergency surgery - including hysterectomy - to have Essure removed.”
Essure fetal death
Another and most disturbing complication is fetal death. In February 2016, an analysis conducted by independent consultancy Device Events found that hundreds of fetal deaths were linked to Essure - a number that Bayer did not disclose. Madris Tomes, founder and CEO of Device Events and former FDA employee - she was working on the FDA adverse event reporting program - created a system whereby she can search the entire FDA medical device adverse events data since 1996.
MedWatch adverse events are reported by physicians, patients, family members and the device manufacturer. As of last fall, the MedWatch form has one box to check for death. “I noticed that many Essure reports had checked fetal death under injury, while some checked under death were fetal death,” says Tomes.
“Some women had died but I was seeing fetal deaths - miscarriage, ectopic pregnancy and stillbirth - checked as injury,” Tomes explains. “The FDA held an advisory panel meeting last September that included a presentation showing 25 deaths, five of which were fetal deaths. But if they aren’t counting injuries such as miscarriage as fetal death, they are missing a lot.”
Tomes investigated further. She found 303 reports referencing these fetal “death like” terms and provided the information to Congressman Mike Fitzpatrick. “Bayer lashed out, and said it was irresponsible to say Essure causes fetal death, but I didn’t say that,” explains Tomes. “Once it was understood how I was sourcing the data, Bayer had no response. But the FDA said they found 294 ‘failed pregnancies,’ which is semantics. If the agency doesn’t want to call them fetal deaths, that’s up to them. Women with Essure shouldn’t even be getting pregnant so the device is failing in that regard. And an ectopic pregnancy can also kill the mother.”
FDA reports show that the device can migrate far beyond the uterus. Tomes has 10,800 adverse event reports, more than 1,000 of which are from physicians. “Essure has been found buried in the spine, gallbladder, colon or bowel. One report the FDA received said Essure was found in someone’s rectum,” says Tomes. Essure has been issued to about 750,000 women globally, according to Bayer.
READ MORE ESSURE LEGAL NEWS
If you are having any type of Essure side effect, see your gynecologist right away. And you might want to consider legal help. Unglesby says this lawsuit is about Bayer’s decision to deceive doctors and patients about the safety of its products. “We have developed a strong failure-to-warn claim against Bayer and our team is looking forward to advocating on behalf of thousands of women,” added Unglesby.
Attorney Lance Unglesby is partner at Unglesby + Williams, based in New Orleans. They filed suit along with another law firm in St. Louis on behalf of 32 women nationwide who have been injured by the Essure device.