February 23, 2017
Bayer’s 2016 Annual Report has been released, and although the company says it posted a record year in earnings, it does note that as of January 23, 2017, it faces approximately 3,700 Essure lawsuits, with more lawsuits anticipated. Those lawsuits were filed by patients who allege they developed Essure side effects as a result of using the birth control. According to the lawsuits, patients were put at risk of perforation, pain, bleeding, and unwanted pregnancy but were not ever warned about those risks. In addition to the U.S. Essure lawsuits, Bayer says it faces two Canadian lawsuits seeking class-action status.
Bayer Reports Essure Expenses
According to the 2016 Integrated Annual Report, in 2016 Bayer incurred impairment losses of more than $400 million associated with Essure. The company also reports almost $300 million in expenses for “significant legal risks” connected to Xarelto, Essure, and Cipro/Avelox proceedings.
“Bayer believes it has meritorious defenses and intends to defend itself vigorously,” the company noted.
Brazil Recalls Essure
Although Bayer intends to defend itself, Brazil’s National Health Surveillance Agency, Anvisa (Agencia Nacional da Vigilancia Sanitaria) has reportedly pulled Essure off the market. In a news release posted on its website on February 20, 2017, the agency noted that Essure has been linked to unwanted pregnancy, chronic pain, perforation, and migration, and has been classified as the maximum risk. In addition to suspending the distribution and dissemination of Essure, the agency reportedly also recalled units that were distributed, though whether that affected units that were implanted has not been made clear.
In 2016, the U.S. Food and Drug Administration (FDA) issued a black box warning regarding Essure side effects but did not recall the birth control device. That move followed an FDA public advisory meeting regarding the birth control.
Women Experience Issues Removing Essure Birth Control
In addition to side effects linked to Essure birth control, reports have emerged that doctors have had difficulty removing implanted devices. Some women have reportedly required two or three surgeries to remove the Essure implant because the device can allegedly migrate in the patient’s body, making it difficult to locate and remove.
“I have had patients in my experience that have Essure devices up by the liver, by the bowel,” Dr. Steven McCarus, a surgeon, told ABC News. “It is almost like finding the needle in the haystack sometimes.”
According to the ABC report, some patients require the use of a power morcellator to break up tissue and remove the device, but the morcellator might also leave metal fragments in the patient’s abdomen. Some doctors have complained Bayer’s instructions on removing Essure are “lengthy” and “vague.”
Essure Lawsuits Allege Bayer Left Women in the Dark
Essure lawsuits have been filed against Bayer, alleging the company didn’t warn patients about the risk of very real, life-changing side effects. Furthermore, some lawsuits allege the FDA was kept in the dark about Essure side effects because the maker did not forward most complaints to the agency. As a result, crucial information was allegedly kept from women and doctors.
In addition to complaints about unwanted pregnancy and device, migration is concerns about allergies to nickel. Essure is made of nickel titanium. When it was initially approved, it reportedly carried a warning about the nickel, but that warning was removed so women with a nickel allergy might not be aware they’re being implanted with a device that contains nickel components.
Essure was initially made by Conceptus and was purchased by Bayer in 2015. Bayer maintains the safety and efficacy of its device and says it will defend itself against each Essure lawsuit.
If you are considering filing an Essure lawsuit or would like more information about Essure birth control here are some frequently asked questions.