Essure Linked to Serious Health Complications in Women
DALLAS (Feb. 2, 2016) – The national law firm of Baron & Budd is investigating potential legal action against Bayer AG, the manufacturer of the Essure permanent birth control device. The device has been linked to several serious health complications in women, including device migration, fallopian tube perforation, vaginal bleeding and others.
Essure, which gained U.S. Food and Drug Administration (FDA) approval in 2002, is the only non-surgical, permanent birth control device approved by the agency. When inserted by a doctor, it is designed to form a barrier that inhibits the ability of sperm to reach a woman’s eggs. It takes time for the barrier to develop, so a different form of birth control must be used in the meantime.
However, many women have reported severe health problems after use of Essure. The FDA recently announced that it is examining reports of injuries, stating that some women claim they needed surgical procedures in order to remove the device and others state they became pregnant after the device failed. The FDA opened a public docket soliciting comments on the Essure device from July 22, 2015 to October 24, 2015, and during this time it received nearly 3,000 comments. An FDA panel is reviewing the decision-making process that led to Essure’s approval, and the agency stated it expects to reveal its next steps by the end of February 2016.
In October 2015, U.S. Congressman Mike Fitzpatrick of Pennsylvania introduced legislation that would force the FDA to take Essure off the market. The E-Free Act would require the commissioner of the FDA to withdraw the agency’s approval of the device within 60 days.
“There has been growing concern regarding the safety of this device, with women across the country saying they have suffered devastating injuries,” said Russell Budd, president and managing shareholder of the national law firm of Baron & Budd. “We are watching developments regarding this matter closely, and will be prepared to act quickly to protect the rights of women who may have been harmed by alleged negligence.”
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The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, New Orleans, Austin and Los Angeles, is a nationally recognized law firm with a nearly 40-year history of "Protecting What’s Right" for people, communities and businesses harmed by negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals and government and business entities in areas as diverse as dangerous pharmaceuticals and medical devices, environmental contamination, the Gulf oil spill, financial fraud, overtime violations, deceptive advertising, automotive defects, trucking accidents, nursing home abuse, and asbestos-related illnesses such as mesothelioma.