Unsure About Essure®
March 31st, 2016|
On February 29, 2016, the U.S. Food and Drug Administration (FDA) announced it would require the permanent, implantable contraceptive device Essure® to carry a black box warning regarding some of the serious risks associated with its use. While we appreciate the FDA finally taking action, the product has been on the market since 2002, and thousands of women have reported Essure side effects and life-altering complications since its approval 14 years ago.
The FDA is responsible for protecting the public health by ensuring drugs and medical devices intended for human use are safe and effective. Many envision FDA doctors in white lab coats testing the safety of drugs and devices before they are approved and put on the market, but that is not how it works. Before a drug or device is approved, the FDA reviews data that drug and medical device companies provide from their own testing. These limited tests are not run by the FDA and as we see in many drug and medical device trials, companies pushing to get their drugs and products onto the market quickly often provide incomplete, inaccurate, or even fraudulent data.
In 2002, when the FDA approved Essure, they were concerned that test subjects had only been monitored a year or two and asked that trial participants be monitored for four more years. Essure side effects reported during this trial and subsequent trials were recurrent pain, perforation of the fallopian tube, migration, painful intercourse and menstrual periods, hysterectomies, and other surgeries to remove misplaced coils.
So how can you help ensure that the FDA will be more sure about product safety before putting products like Essure on the market? You can become more aware about the FDA’s role in approving medical devices by visiting the FDA website on medical devices. You should also report any side effects you experience from a drug or product to MedWatch, the FDA safety information and adverse event reporting program. If you do suffer from Essure side effects and are interested in an Essure lawsuit, please call our office at (800) 521-4492 or contact us online to speak with our experienced staff who can connect you to an Essure attorney.