Last week, the Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices Advisory Committee made several recommendations regarding Bayer HealthCare’s permanent female sterilization device, Essure.
Last week, the Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices Advisory Committee made several recommendations regarding Bayer HealthCare’s permanent female sterilization device, Essure:
Additionally, panel members noted that the “ideal patient” for the procedure includes women at high risk for possible dangers of other forms of surgical, permanent birth control, and who understand the risks of Essure. They stated Essure should not be recommended for patients with hypersensitivity to metal or with nickel allergies, those with autoimmune disorders, a history of inflammatory diseases or abnormal uterine bleeding, and those who have had previous uterine surgery.
The panel’s recommendations followed a 12-hour hearing that stretched into the evening last Thursday, as patients, experts and Bayer representatives gave testimony. Throughout the hearing, patients described a variety of negative side effects they experienced after device implantation, some of which were considered serious adverse events. At this meeting, the FDA committee specifically studied and heard testimony on implant perforation and migration, bleeding, chronic abdominal pain, headaches, allergic reactions and unintended pregnancy. The panel also discussed incidents in which women opted to remove the implants, whether due to adverse side effects or for other reasons.
The common refrain from panel members was that more information — more data — was needed.
Essure gained FDA approval in 2002 for women aged 21 to 45 years. It consists of a delivery system and a pair of soft, nitinol — a nickel-titanium alloy — spring implants. The implants are inserted through the vagina into each fallopian tube, causing scar-tissue growth, which over the course of months causes tubal occlusion, preventing eggs from being fertilized or from moving to the uterus.
“I feel that the answer from the patient’s point of view is still out there,” Jo-Ellen De Luca, of the FDA Patient Representative Program, said during the meeting. She added, “I think this has been a great opportunity to find some possible answers, but I think there’s still some great unknowns. I lead a very large support group, and I know a lot of patients will be — while they’re not here today — concerned around the country, looking for answers when this comes out. I think we’ve had plenty of patients that have been here that don’t have their questions answered, and I feel that will continue.”
The FDA is not bound by their advisory committees’ recommendations; however, they are often followed.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us