Last week, Bayer announced that it would suspend sales of its Essure birth control device, citing a substantial decline in sales of the device. Essure has been the subject of extensive criticism from consumers, health officials and advocacy groups, as thousands of adverse event reports allege the device has led to a number of severe and dangerous complications.
On July 20, 2018, Bayer announced that it would halt the production and sales of its Essure birth control device by the end of the year. The company stated that the decision was influenced by a substantial decline in sales and was not a result of the ongoing litigation brought by thousands of women and their families.
What is Essure?
In 2002, Bayer HealthCare received pre-market approval from the Food and Drug Administration (FDA) for its Essure device—a hysteroscopic implant method of sterilization that provided a less invasive alternative to other hysteroscopic procedures used. During the procedure, metal coils are implanted into a patient’s fallopian tubes. Theoretically, over time, scar tissue should then form around the coils, thereby blocking the ability for conception to take place. The Essure device amassed popularity with physicians and patients shortly after market introduction because the procedure required less time and money, and the use of anesthesia was not required.
However, since its inception criticism has surrounded Essure’s continued use, with many patients, doctors and health advocacy groups claiming that it is unsafe. Such criticism is supported by nearly 30,000 adverse event reports submitted to the Food and Drug Administration, which allege that women who received the implant suffered various complications and severe unexpected side effects after implantation.
The most common complications reported relate to severe pain in the pelvis, hemorrhaging and migration of the device within the uterus. Such effects have necessitated operation, and in some instances removal of the device. The effects caused by additional operations have led to ectopic and unintended pregnancies, which can be potentially fatal under certain conditions.
Reported side effects of the device include:
- Excessive bleeding
- Allergic reaction
- Pelvic pain
- Unintended pregnancy
- Ectopic Pregnancy
Bayer continues to deny allegations that the device is unsafe and has caused the alleged injuries.
Recalling the Device
Bayer’s recent announcement comes only months after the Food and Drug Administration mandated that sales of the device were to be restricted to doctors who provide their patients with detailed risk and benefits information. The move was influenced by thousands of reports that patients were not being adequately informed of the potential effects of the device. Bayer has suggested that this mandate, among other factors, led to the rapid decline in sales and the ultimate decision to discontinue the device altogether.
Ongoing Legal Action Against Bayer
More than 15,000 legal claims have been filed against Essure’s manufacturer by women who claim that the device led to unexpected pain, suffering and damages. Several plaintiffs have even alleged that complications from the device caused the death of a loved one who received the implant, or the death of an infant developing after the device’s failure. Despite its continued denial of such allegations, Bayer has stated that it will continue to work with the FDA to enroll patients in, and monitor results of, a post-market study regarding the device’s use.
For more information about lawsuits related to Essure, or to speak with an attorney regarding your individual experiences with the device, contact the Law Offices of Peter Angelos.