Essure Problems Being Reported to FDA

 Posted on March 14, 2014 in FDA

In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.

Although the FDA has received more reports of complications from women who have gone through the procedure, the federal agency still classifies the risk of adverse events as “low”. In addition to clinical studies, the FDA also reviews surveillance data sources post-market to determine how safe and effective a variety of medical devices are in practice.

Reports submitted to the FDA by consumers are helpful in identifying problems as soon as possible so that if defects or complications are a factor, other patients can be warned before being affected.

Essure was the subject of a five year follow up study that took into consideration how well the procedure prevented pregnancy, the safety of the total procedure, and patient comfort and safety after implantation. Patients who have gone through the procedure are reporting discomfort and strange ailments, including joint problems and thinning hair.

Although the FDA collects reports regarding medical complications and other problems on an ongoing basis, it can be several months or even years before the agency steps in with requirements or recommendations designed to help protect future patients.

Suffering complications or injuries after a procedure can be frustrating and painful. Those complications leading to follow-up care or additional procedures can also be expensive. If you or someone you know has been injured as a result of the Essure procedure or a defective medical device, you need to contact an Illinois personal injury attorney today.