FDA Investigates Essure Sterilization Device
Essure is a permanent, sterilization device implanted in the fallopian tubes. Marketed as the only permanent birth control available for implant via a nonsurgical procedure, the device, which was developed by Conceptus Inc, a subsidiary of Bayer AG, received FDA approval for use as permanent birth control in 2002.
After collecting thousands of reports of medical complications from women across the United States, the FDA has launched an investigation into allegations that Bayer misled the public and federal regulators with its statements about the safety and efficacy of Essure. There have also been allegations that the company falsified or altered medical records of the patients involved in the clinical trials, and that Bayer used defective materials during the manufacturing process. These materials include low-quality metals that could corrode and lead to nickel allergies and metal poisoning.
Side effects reported by Essure recipients include:
- Extreme pelvic pain
- Cramping in the pelvic region not associated with menstruation
- Menstrual irregularities
- Severe back pain
- Serious, inexplicable fatigue
- Weight gain or weight fluctuation
- Device migration or breakage, which can result in organ perforation
- Heavy, irregular bleeding not associated with menstruation
- Painful intercourse
- Painful menstruation
- Adverse reactions due to nickel allergy
- Depression or suicidal thoughts
In many cases, side effects were so severe that Essure had to be surgically removed.
Bayer claims that Essure has a “well-documented benefit-risk profile,” and that the device has been implanted successfully in 750,000 female patients. The pharmaceutical manufacturer claims that the devices are 99% effective in preventing pregnancy in patients, and the risks of harm are “rare.”
A study published in the British Medical Journal (BMJ) on October 13, 2015 concluded that Essure was not more effective at preventing pregnancy than a similar laparoscopic procedure. However, despite the fact that Essure is implanted during a non-surgical procedure, Essure had a “10-fold higher risk of undergoing reoperation” compared to patients who underwent a laparoscopic tubal ligation procedure. Ironic given that Bayer markets the initial nonsurgical implant as advantageous.
Defective Device Claims
A number of personal injury claims have been filed against Bayer accusing the company of providing misleading information and design/manufacturing defects, including:
- Failing to report, and actively concealing, perforations
- The use of non-conforming materials in the manufacture of Essure
- Manufacturing Essure at an unlicensed facility
- Falsifying medical data.
Plaintiffs allege that Bayer “was concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same.” Many plaintiffs argue that the class action protection afforded Essure by the premarket approval process should be removed.
Strom Law Firm Investigates Essure Injury Claims
If you live in South Carolina or Georgia, and you or a loved one suffered complications after implantation of an Essure device, contact the Strom Law Firm for a free consultation. Our firm is now investigating claims against Bayer AG, so contact us today.