FDA Restricts Sale of Essure Contraceptive
In April 2018, the U.S. Food and Drug Administration (FDA) implemented new restrictions on the sale and distribution of a permanent contraceptive product called Essure. According to the FDA, women are not being properly informed of the potential risks associated with the Essure procedure and product. As a result, many recipients are experiencing painful side effects and medical complications, despite not having been made aware of the dangers or providing informed consent.
Problems & Injuries Associated with Essure
Essure is a female sterilization device produced by Bayer. When Essure is being implanted, a metal coil is inserted into the fallopian tubes. This causes them to scar and thicken, which eventually blocks the fallopian tubes, resulting in irreversible inability to conceive.
The FDA reports that many women who receive the Essure implant experience negative side effects, including:
- New allergies or sensitivities
- Joint pain
- Muscle pain of weakness
- Significant weight gain or loss
- Migraines and headaches
- Hair loss
Patients have experienced abnormal bleeding, painful intercourse, unintended pregnancy, and more.
Essure also presents a number of serious risks. The small metal coil can do serious damage once implanted, especially if it moves out of place. In some cases, the coil has poked holes in the fallopian tubes or slid out of the fallopian tubes into the pelvic or abdominal cavities.
FDA Restrictions Cause Major Decline in Sales, but the Problem Persists
Essure has been approved by the FDA since 2002. Many women have experienced painful reactions and damage from the implanted device, despite not having been told about the potential dangers the product could pose.
In response to the barrage of women who were harmed by Essure and never made fully aware of the risks, the FDA took action to keep it from continuing to happen. The administration requested a study on the product’s safety, required providers to include a visual/written warning on the product, and revised the packaging to include mandatory patient decision information. As a result, sales have plummeted by roughly 70 percent.
The FDA has also limited Essure distribution in such a way that the product can only be delivered to hospitals and other health care providers. They have also required doctors to go over the potential risks with prospective Essure patients by using an informed decision checklist. Then, both the physician overseeing the implantation process and the patient receiving Essure must sign an official acknowledgement that informed consent has been given and the patient is aware of the potential risks associated with the metal coil contraceptive device.
Dangerous Medical Device Lawyers
Our team at Kershaw, Cook & Talley can help if you have been harmed by an Essure implant. We are motivated to help you get the compensation you deserve, and we are not afraid to take on healthcare organizations, device manufacturers, or other potentially intimidating entities.