The Food and Drug Administration (FDA) told Bayer-manufacturers of Essure-they must undergo a new postmarket surveillance study of the permanent birth control that analyzes the heightened risks to patients. “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the FDA said in a press announcement.
Essure is supposed to create a natural barrier in the fallopian tubes so sperm can’t reach the eggs, preventing pregnancy. A physician implants the device through the vagina and into the fallopian tubes, where it produces an immune response causing tissue build-up in the fallopian tubes. Essure was approved by the FDA via the Premarket Approval (PMA) process and is a class III device, generally the highest risk devices and subject to the highest level of regulatory control. Despite this “high” level of regulatory control, many women are experiencing life-threatening side effects from Essure. Devices with PMA from the FDA are protected from product liability lawsuits brought in state courts. The court found that federal preemption prohibits state law claims that challenge the safety or effectiveness of PMA devices. If the PMA is revoked, individuals may be able to file a lawsuit.
The agency has received over 5,000 adverse event reports from women regarding their Essure device. The complaints include side effects ranging from pregnancy, pelvic pain, cramping, migration, allergic reactions, and perforation of the fallopian tubes and uterus. Many of these women are forced to undergo surgery for removal of their fallopian tubes (Salpingectomy), or removal of their uterus (Hysterectomy). Essure was approved on November 4, 2002. According to the FDA, “From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.” Unfortunately, the FDA still has not selected to revoke the Essure PMA. However, the effort to revoke the PMA application is ongoing.
Instead, the FDA released a statement recommending that sterilization devices, such as Essure, include a Black Box warning label, a label required for devices that potentially cause death or serious injury, explaining the possible side effects. The agency’s recommendation was published as a draft guidance with labeling recommendations for Essure. The FDA will finalize the guidance information after receiving comments from the public and the industry for two months.
Know Your Rights
In cases where it can be shown that the manufacturer of the medical device lied to the FDA to obtain approval, or failed to report adverse events with the product, a product liability case may be viable. It is important to protect your legal rights and have a case on file. Contact an Essure injury attorney at Kershaw, Cook & Talley for a free case consultation at 888-997-5170, or fill out our confidential online form found on this page.
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