Nearly 100 women nationwide have filed a large lawsuit in the Circuit Court of the City of St. Louis, State of Missouri, against Bayer over allegations that the Essure permanent birth control led to complications and injuries.
The 98 women allege that Essure let to serious complications and permanent injuries following their being prescribed and implanted with the allegedly defective birth control device.
The Essure system is a non-surgical contraceptive device manufactured with two metal coils that are implanted into a woman’s fallopian tubes. As the coils expand, they are meant to encourage tissue growth. The scar tissue blocks the fallopian tubes, preventing conception. Essure was promoted as a simple and safe solution to permanent birth control needs.
Now, at least 98 women allege having suffered Essure birth control complications and that Bayer minimized Essure’s safety risks. According to the recently issued 191-page complaint, allegations include that, Bayer “carefully manipulated its reports to the FDA and presented false and misleading information” about Essure birth control complications in an effort to protect its sales. Many of the women allege complications that, in come cases, required hospitalization, hysterectomy, or surgery to remove the Essure, including:
• Device migration
• Heavy metal toxicity
• Hypervolemia (fluid buildup in blood)
• Irregular bleeding
• Organ perforation
• Persistent pelvic pain, cramping
• Pregnancy, ectopic pregnancy
Initially, Conceptus, a Bayer subsidiary, manufactured and marketed Essure, which received U.S. Food and Drug Administration (FDA) clearance in November 2002 through the Premarket Approval (PMA) process as a Class III device. Class III devices are subject to the highest level of regulatory control. Meanwhile, according to the FDA, “Over the past several years, the [agency] has been examining the growing number of reports of harm with Essure. The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.”
On September 24, 2015, the agency met with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to hear expert clinical opinions and patients’ experiences concerning the benefits and risks of Essure. On February 29, 2016 the federal regulators announced its recommendation that sterilization devices, including Essure, include a “Black Box” warning label. A Black Box warning is the agency’s most stringent and mandated for devices that may potentially cause death or serious injury, explaining the possible side effects.