Ennis & Ennis, P.A.
Women Urged To File Essure Adverse Events Reports With FDA
05/22/2015 - Any woman who has suffered an injury or adverse event relating to an Essure sterilization device is urged to file an Adverse Event report with the FDA as soon as possible. The FDA appears to be undertaking a half-hearted investigation into the serious and substantial allegations presented by thousands of women affected by the product. On April 2, 2015, three administrators from the advocacy group Essure Problems and two doctors met with 30 members of the FDA. Testifying on behalf of the Essure victims was Dr. Diana Zuckerman, president of the National Center for Health Research. Also testifying was Dr. Shawn Tassone, an OBGYN, who previously implanted the device, but ceased after realizing the numerous problems it created for the implanted women.
Kim Hudak, a clinical trial participant testified that the original Essure manufacturer, Conceptus, altered her patient records before submitting the data to the FDA during the approval process. This factor alone should invalidate the pre-market approval for the device. Other women who’s lives have been radically altered by the device, offered their stories as well. Mass emails from affected women were also sent to the FDA members who attended the meeting. The women were advised to send emails only to William Maisel and Abiy Desta and they would be disseminated to the entire committee. There has been no word whether this is being accomplished or if the FDA is conducting a serious investigation into these complaints.
It is difficult to trust the word of the FDA representative, William Maisel, who obviously has no respect for females. In 2012, the top FDA official was charged in connection with soliciting a prostitute in Howard County, Maryland. Maisel was charged with four counts of soliciting prostitution and one count of disorderly conduct. Maisel was also connected to a FDA scandal in which FDA officials spied on the agency’s own scientists, who had expressed concerns about the safety of medical devices, according to the Washington Post. Maisel’s conduct raises huge red flags regarding who the FDA is actually seeking to protect: big pharmaceutical companies or thousands of patients injured by defective devices and medications allowed into the marketplace.
A Citizen’s Petition to remove Essure from the market was filed in February with the FDA. The petition asserts that Essure’s Pre-Market Approval for the device (PMA) was not only unusually rushed, but was based on fraud, lies and cover-ups, which intentionally deceived the FDA. Essure’s original manufacturer, Conceptus allegedly falsified data during clinical trials to hide or downplay adverse reactions and injuries caused by the device. Women who reported significant pain had their medical records altered to indicate satisfaction with the product or minimal discomfort. Many cases where the coils migrated out of the fallopian tubes and perforated the uterus or other organs were allegedly never reported to the FDA. It is clear the any and all women who were injured by the device need to keep fighting and make sure your voices and complaints are heard with the FDA.
If you or a loved one have been injured by Essure, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.