The U.S. Food and Drug Administration (FDA) recently approved a new boxed
warning for Essure permanent contraception. The new warning follows thousands
of adverse event reports associated with the use of the medical device.
As we have
previously discussed on this San Diego Injury Blog, Essure is touted as a safe alternative to tubal ligation as a means of
permanent birth control. However, patients implanted with the device report
a range of serious side effects, including perforation of the uterus or
fallopian tubes, chronic pain, bleeding, autoimmune disorders, and severe
The boxed warning includes safety statements that detail significant side
effects or adverse outcomes associated with Essure. It also provides information
about the potential need for removal. "If the device needs to be
removed to address such an adverse event, a surgical procedure will be
required," the boxed warning states.
A Patient Decision Checklist was also added to the product labeling. It
provides key information about the device, its use, and safety and effectiveness
outcomes of which the patient should be aware and discuss with her doctor
as she considers her sterilization options.
The FDA has also concluded its investigation into several allegations against
the Essure’s manufacturer, Bayer AG. They include clinical trial
misconduct and violations of FDA regulations governing the manufacturing
and marketing of Essure. The FDA has also ordered Bayer to conduct a postmarket
surveillance study to obtain more data about the medical device’s
benefits and risks.
If you or someone you care about has suffered serious harm due to a dangerous
or defective medical device, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation. Our legal team has successfully represented clients
against manufacturers and distributors of medical devices for more than 30 years.