It’s only been a few months since the FDA and Bayer announced that they would be extending a postmarket safety study involving the birth control implant, Essure, by two years. Now the FDA has announced that they will be taking a close look at the materials that are being used in numerous medical devices.
FDA Will Study Biocompatibility Of Implants
In a press release that was issued on March 15th, 2019, the FDA Commissioner, Scott Gottlieb, M.D., addressed the FDA’s regulatory process and the changes that they would be making.
In the statement, Gottlieb indicated that the regulatory process for the FDA was implemented to ensure that as many patients as possible would have access to safe medical devices and treatments. While the majority of patients do not suffer from adverse reactions when a medical implant is placed in their body, those that do typically suffer a traumatic injury.
In 2016, the FDA released guidelines for companies to follow so that a biocompatibility report would be submitted during the approval process for a new medical device. These biocompatibility reports are supposed to show that companies have determined that their medical device won’t cause adverse reactions – including reactions to the materials used to build the device.
However, as Gottlieb notes, medicine is constantly evolving. “Our understanding of medical technologies evolves over time. As we learn more about long-term effects of materials and as materials science advances and new innovations become a reality, it’s imperative our regulation of devices evolves along with these advances to ensure patients are protected.”
Gottlieb goes on to note that many patients with adverse reactions don’t actually present with symptoms until months or years after a medical device has been implanted which is why so many premarket studies fail to discover potential issues. This is why the FDA is now taking additional steps to fill potentially critical gaps in the safety of medical devices.
How Is Essure Impacted By This Latest FDA Announcement?
In addition to noting that the postmarket safety study had been extended, the FDA announced that women with the implant will require additional bloodwork to look for inflammatory markers. The FDA is specifically monitoring the nitinol in the device, which is an alloy of nickel and aluminum.
Although other medical devices with nitinol have been implanted in patients without adverse reactions, the FDA is concerned that since Essure is implanted in the uterus, the tissue may be more sensitive to the alloy, resulting in inflammation and other issues.
The ongoing monitoring of Essure may provide current and future plaintiffs with further proof that Bayer created a birth control implant that was dangerous.
I Heard You Can’t Sue Because Of Premarket Approval – Is The True?
When a company has a medical device go through the premarket approval process, the process is so stringent that approval typically means that the company is then protected from product liability claims. Essure did go through this premarket approval process.
However, after a careful review, a California judge determined that lawsuits against Bayer could still move forward.
You Can Still File An Essure Lawsuit
If you have been harmed by Essure, you may still be eligible to file a birth injury lawsuit. Over 18,000 woman have filed and are fighting together for justice.
A birth injury lawsuit may provide you with the compensation that you deserve. This compensation can cover monetary losses such as medical expenses and lost wages, as well as nonmonetary losses such as physical pain and emotional trauma.
Contact our experienced legal team today for a consultation. We will review your case and then advise you about each of your legal rights.