The U.S. Food and Drug Administration (FDA) recently announced that it
will require the Essure birth control implant to carry the strongest safety
warning label. The black box warning follows thousands of adverse event
reports associated with the use of the medical device.
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
As detailed in a recent statement, the FDA intends to require that a boxed
warning and Patient Decision Checklist be added to the product labeling.
The safety statements set forth in the boxed warning are intended to better
communicate to patients and providers the significant side effects or
adverse outcomes associated with the Essure device and other permanent
hysteroscopically-placed tubal implants. Meanwhile, the Decision Checklist
contains key items about the device, its use, and safety and effectiveness outcomes.
The FDA also issued
draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants
Intended for Sterilization,” to provide the public an opportunity
to comment on the proposed language to be included in these warnings.
After a 60-day comment period, the agency will make any necessary changes
and issue final guidance.
In addition to the new FDA warnings, the agency continues to investigate
a number of allegations against the maker of Essure, Bayer AG. They include
clinical trial misconduct, notably that clinical trial participants’
medical records were altered to reflect more favorable data about participants’
experiences, as well as violations of FDA regulations related to the manufacturing
and marketing of Essure. The FDA has also ordered Bayer to conduct a postmarket
surveillance study to obtain more data about Essure’s benefits and risks.
If you or someone you love has suffered serious harm due to a recalled
or otherwise defective medical device, you may be entitled to compensation.
To discuss your legal rights, contact
a San Diego medical product liability lawyer at the Law Offices of Robert
Vaage for a free consultation.