On Thursday December 20, 2018, FDA Commissioner Scott Gottlieb, M.D., released a statement discussing the concerns surrounding Essure and the plans moving forward. Essure, a permanent birth control device linked to serious adverse effects in women, has also been the center of thousands of lawsuits filed by women worldwide.
With Bayer announcing it will no longer sell or distribute Essure in the U.S. come the end of the month, Gottlieb focuses his statement on providing updates about new steps the FDA is taking to revise and strengthen the post-market study of Essure. This includes the collection of long-term safety information after sales of Essure are discontinued, and better evaluation of the device’s safety profile when used in the real world.
As part of the post-market surveillance study’s revised protocol, the FDA and Bayer will adopt steps to strengthen the collection of evidence. These modifications include:
- Increasing the study of women with Essure implants from three years to five years, which is a significant extension beyond the legal requirement. The increased study period will provide more information on long-term adverse risks associated with Essure, including health issues and complications that may necessitate surgical removal.
- Additional blood testing will be required for patients who are enrolled in follow-up visits during the surveillance study. These tests will provide more insight about increased inflammation in patients, help improve evaluation of potential immune reactions, and facilitate better assessment of findings associated with Essure patient-reported symptoms.
- The FDA will require Bayer to continue enrollment of any patients who may choose to receive Essure prior to its full discontinuation, and to submit reports with increased frequency about the progress and results of the study to the FDA. The modification is intended to compensate for reductions in sales that followed the FDA’s 2016 decision requiring Bayer to conduct a post-market study and add a boxed warning and Patient Decision Checklist to its labeling.
Gottlieb goes on to express the FDA’s commitment to continue it’s monitoring of the post-market study, and oversight of women who have the birth control device implanted. The agency has also announced advancements that will improve its monitoring systems and help regulators reach a new goal to be among the first agencies in the world that identifies and acts upon safety issues involving medical devices, such as its Medical Device Safety Action Plan, and the National Evaluation System of Health Technology.
Improving Medical Device Safety
Gottlieb’s statement and discussions of shake-ups and improvement plans within the FDA are welcomed, but the fact remains that federal regulators have considerable ground to cover when it comes to improving its oversight of dangerous and defective medical devices. In fact, many consumer advocates have expressed the need for the FDA to do more when it comes to preventing these types of events from happening in the first place. As Canadian health regulators recently announced, their plans to improve oversight of medical devices also include changes to the country’s pre-market approval process – somethings that’s desperately needed here in the U.S.
Additionally, while the statement does show the FDA is committed to studying long-term risks associated with Essure, it does little to help women stand up and protect their rights after they have already suffered harm and losses. That particular goal is one which victims and families will need to turn to the civil justice system and experienced civil trial lawyers to address.
Experiencing Adverse Effects Associated with Essure? Learn More About Your Rights.
At Bailey Cowan Heckaman PLLC, our nationally recognized attorneys are all too familiar with rectifying the failures of others, and holding them accountable for the preventable harm, pain, and suffering they cause. This is especially true when it comes to fighting back against the powerful corporations and pharmaceutical companies behind dangerous medical devices. We care about making a difference, and know that doing so requires decisive and determined action, not just promises and plans.
If you or someone you love has suffered adverse health consequences as a result of using Essure or any other dangerous medical device, pharmaceutical, or consumer product, our firm is here to explain your rights and options, and discuss how we may be able to help you pursue the justice and compensation to which you are entitled. Call (888) 367-7160 or contact us online to speak with a member of our team. Bailey Cowan Heckaman PLLC serves clients nationwide.