Women claim the birth control device causes pain, menstrual problems
July 19, 2017
A federal judge in Missouri has removed 86 of the original 94 plaintiffs in a lawsuit over Bayer's Essure birth control device. Judge Carol Jackson said that only women who had the devices implanted in Missouri could participate in the action.
The Missouri case is one of thousands filed in the U.S. by consumers who say they have been harmed by the device.
Essure is a small metal coil that is placed in the fallopian tubes using a catheter.After about three months, scar tissue forms around the coils and is supposed to prevent pregnancy.
But there have been complaints from women who say they have suffered pain and menstrual irregulatiries after Essure was implanted. In 2015, the U.S. Food and Drug Administration (FDA) said it had received 5,093 complaints in the 13 years since Essure's approval.
Bayer said in its most recentfinancial statementthat as of January 23, "U.S. lawsuits from approximately 3,700 users of Essure ...had been served upon Bayer."
Besides the pain and menstrual problems, the FDA said there had been five fetal deaths and four reports of adult deaths caused by infection and uteriine perforation.
Many of the most serious complications have occurred in cases where women asked their doctors to remove the device, either because of pain or regret over their initial decision to be permanently blocked from conceiving.
In some cases, the device breaks upon removal, possibly leaving fragments behind, according to reports in legal and medical journals.
"Meritorious defenses"
In February,Johannes Dietsch, a Bayer board member, said in an address at a financial conference that Bayer had so far suffered "impairment losses of 561 million Euros recognized on intangible assets, particularly in connection with Essure."
"Plaintiffs allege personal injuries from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy. As of January 23, 2017, two Canadian lawsuits relating to Essureseeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously," the company said in its 2016 financial report.
In 2016, the FDA issued updated guidelines requiring new labeling requirements and a patient checklist to help reduce potential problems.About 1 million of the devices have been implanted since 2001.