On July 20, the manufacturer announced that its Essure sales and distribution in the United States would be discontinued by December 31, 2018. Aside from declining sales, Bayer attributed the decision to women’s reduced use of permanent contraception in addition to misleading and inaccurate publicity about the implant. The Bayer announcement came close to a week before The Bleeding Edge documentary premiered on Netflix.
The Bleeding Edge Targets Defective Devices like Essure
The Bleeding Edge documentary focuses on the health issues caused by different medical devices, including Essure. The filmmakers released a statement in response to the Bayer decision, claiming that the move legitimized their work, which has helped change policies and history at large. However, Bayer did not specifically identify the filmmakers or the highly-anticipated documentary in their July-20th statement.
Bayer Under Pressure Over Essure Side Effects
Bayer has been under heavy pressure by women claiming they’ve suffered serious side effects caused by the medical implant. The latest annual report from Bayer showed that as of January 2018, over 16,000 women have filed lawsuits over the Essure birth control implant. Some speculate that the new Netflix documentary could cause the number of Essure lawsuits against Bayer to skyrocket as more women learn that the implant is likely to be the cause of certain ongoing health issues.
Bayer Defends the Essure Birth Control Implant
In its recent statement, Bayer maintains that the Essure medical implant is safe and effective for women. The manufacturer also cited FDA’s earlier position that the benefits of the medical implant far outweigh the potential risks. In addition, Bayer noted that Essure is the only non-incisional form of permanent birth control approved by the FDA. The statement conveniently ignores the FDA decision in April to restrict Essure sales and distribution to health care providers in compliance with the new patient decision checklist.
Essure’s History of Severe Side Effects
Before the new patient checklist requirement, the FDA ordered a new box warning label in 2016 and mandated that Bayer provide ongoing postmarket analysis for the Essure’s safety and effectiveness. Between 2002 and 2017, the FDA received close to 27,000 adverse event reports about the Essure permanent birth control implant. Some of the side effects cited in the reports included device dislocation, sudden weight fluctuations, and abdominal bleeding and pain.
Over 1,800 women still got pregnant after having the Essure birth control device implanted. While many were overlapping with the FDA, Bayer turned over its own set of 11,000 reports detailing complaints about the side effects caused by Essure. All the aforementioned risks notwithstanding, many think that permanent birth control options are becoming less popular with women. However, even the removable, less-permanent options like Bayer’s Mirena have had their own issues.
The Essure lawsuits were not mentioned in Bayer’s as a reason for pulling the birth control from US markets. The manufacturer has not offered any settlements to the plaintiffs reportedly harmed by the side effects. It’s more likely that Bayer intends to continue to fight against any new and existing Essure lawsuits. The permanency aspect of the device leaves Bayer susceptible to litigation for years to come.
Women who suspect their health is suffering due to symptoms caused by the Essure implant should contact a lawyer immediately for a consultation.