A new Essure postmarket surveillance study plan sponsored by the contraceptive’s manufacturer, Bayer, will investigate the side effects thousands of women have reported. The U.S. Food and Drug Administration approved the study on September 2, 2016.
In a related action, the FDA publicly denied allegations that Bayer had altered clinical trial results to attain an FDA premarket approval (PMA) after review. While the FDA’s findings definitively dismiss a key argument injured patients had made, the new postmarket study may reveal new information about Essure’s safety and efficacy that could aid the patients’ cases.
Bayer study to last into 2023
The study will select two groups of 1,400 women between the ages of 21 and 45 years who underwent Essure implantation. The study begins in September 2016 and will continue to monitor the subjects until September 2023.
The FDA requires Bayer to submit periodic reports beginning on March 3, 2017 at the sixth-month mark. The reports will contain information regarding adverse developments in the subjects, including:
- Hypersensitivity and allergic reactions to the device or adverse autoimmune reactions.
- Unusual uterine bleeding.
- Chronic pain in the lower abdomen and/or pelvis.
- Other related side effects.
The study will also monitor the subjects’ reactions to pregnancy and Essure removal surgery. These conditions are often cited in Essure litigation as alleged side effects. The results of the study, which will first be reported in March 2017, will provide insight into the validity of thousands of claims from women allegedly injured by Essure.
Anyone who is currently launching a lawsuit against Bayer’s Essure may want to monitor this new study as its results may prove advantageous to their case. The FDA will update its webpage with news on the study and provides contact information for questions and additional information.
FDA clears Bayer of data tampering
The FDA cleared Bayer of allegations over tampering with Essure trial results following a review of a trade complaint. Data manipulation was one of several key allegations in Essure litigation that accused Bayer of tampering with information that was vital in marketing its device and attaining a PMA from the FDA. The allegations include:
- Alteration of clinical trial patient medical records.
- Violation of PMA order terms.
- Violation of federal laws on the manufacturing and marketing of medical devices.
According to the plaintiffs in Essure litigation, Bayer had allegedly tampered with the information to meet the FDA’s requirements for PMA. However, the FDA found in its review of the allegations that “less than 1% of case report form data pertaining to pain, bleeding, device placement/movement and pregnancy were changed during the clinical trials.” Additionally, the modifications did not favorably influence Essure’s PMA.
The FDA also notes that its review presented “several limitations,” including the amount of original information available from the PMA review process that had taken place 13 years ago.
Despite the limitations, the FDA concluded that there was no evidence that Bayer tampered with the data to Essure’s favor.
Get legal help
These recent developments may significantly impact Essure litigation going forward. If you have a personal injury case in relation to the permanent contraceptive device, you should consult with an attorney who has experience in Essure and medical device liability cases. An attorney can keep you appraised with how these and future developments affect your case.