FDA Takes Action to Inform Patients About the Risks in Using Essure
Posted On behalf of Pfeifer Morgan & Stesiak on Mar 01, 2016 in Product Injury
On Feb. 29, the Food & Drug Administration (FDA) issued a news release announcing it would be taking action to provide women with important information about the risks of using Essure, a form of permanent birth control.
The FDA said the labeling for Essure would now require a “black box warning,” which is used to denote products that have serious or life-threatening risks associated with its use. A public draft guidance has been issued so that the public may have opportunity to comment on the warnings the product should have.
Along with the black box warning, the FDA issued a new, mandatory clinical study for Essure. The postmarket surveillance study will provide data that could help the FDA better understand the risks associated with using Essure. Some information Bayer, the manufacturer of Essure, must provide includes rates of complications such as surgery to remove the device and unintended pregnancy. Additionally, the study must evaluate how these complications could impact a woman’s quality of life.
A Patient Decision Checklist must also be drafted. This document will be provided to doctors so they may discuss with patients the benefits and risks associated with Essure. Doctors will be required to discuss the importance of a “confirmation” test three months after the device is implanted to make sure that the device was placed properly and worked in forming scar tissue that will prevent a pregnancy.
Essure Side Effects & Complications
Since being approved by the FDA in 2002, more than 5,000 complaints have been made about Essure side effects. Some of the side effects associated with Essure include:
- Device migration
- Organ puncture
- Device breakage
- Debilitating pelvic pain
Some women have reportedly had to undergo hysterectomies after suffering severe complications. One study published in 2015 revealed that women implanted with Essure are 10 times more likely to need follow-up surgeries than those who have their tubes tied.
Though the FDA is making strides, reactions to the announcement reveal that many victims feel the administration failed them. Some are angry that the device is still on the market.
Pfeifer, Morgan & Stesiak offers free consultations for anyone who believes they have been injured by a dangerous or defective product. Our experienced and knowledgeable product liability lawyers can help you determine if you are eligible to file a lawsuit for the damages you have suffered.