Essure Injury Claims Clearly Illustrate The Injustice Of Preemption
March 12, 2015
03/13/2015 - Thousands of women across the county have been seriously injured by a product, which may have been illegally granted preemption and immunity by the FDA. Essure is a permanent birth control method wherein two metal coils are placed inside the fallopian tubes. Over the next several months, scar tissue is supposed to grow and surround the coils, blocking conception. What has resulted however, has been a nightmare for thousands of women experiencing perforated organs, chronic pain, metal coils lodged in colons, birth injuries caused from nickel poisoning, depression and even suicide.
Essure had a questionable start. It was pre-approved by the FDA in 2002. During the approval process, the FDA accepted clinical trial data from Conceptus Inc., the device manufacturer which stood to financially profit from the approval and sale of the device. (Bayer has since purchased Conceptus). When questioned whether this created a conflict of interest, the FDA responded, “Although the manufacturer may submit any form of evidence to the FDA in an attempt to substantiate the safety and effectiveness of a device, the FDA relies upon only valid scientific evidence to determine whether there is reasonable assurance that the device is safe and effective.” The FDA did not disclose what or where the scientific evidence came from regarding Essure.
More importantly, information has come to light that Conceptus misled the FDA about serious harm caused by Essure, including manipulating clinical trials in order to secure Essure’s approval. There are serious allegations that Conceptus downplayed or changed women’s’ complaints of severe pain after having the Essure implanted. Other allegations maintain that Conceptus failed to comply with disclosure requirements when it learned of patients who suffered puncture injuries from Essure. The FDA has cited conceptus more than once for failing to report Essure complaints within the 30-day time frame mandated. Dr. Diana Zuckerman, President of the National Center for Health Research recently commented, “I have no idea how safe this medical device is and neither does anybody else.”
The deception on which Essure was approved has far-reaching and devastating implications. Essure is classified as a Class III medical device, which requires pre-market approval by the FDA. Once a product is approved for sale in the US by the FDA under this process, the devices is pre-empted which means people injured by the product have no legal recourse against the manufacturer and can not receive compensation for their injuries. Typically, Class III medical devices are life saving devices such as heart stints. The only other non life-saving Class III approved devices are breast implants. Again, the entire approval process for Essure was questionable at best and quite possibly illegal and fraudulent. If you or a loved one has been injured by Essure, contact the attorneys at Ennis& Ennis, P.A. for a free confidential consultation.