Essure was designed as a permanent form of birth control for women. The product was developed and manufactured by Conceptus, and was submitted to the U.S. Food and Drug Adminstration for approval in April 2002. The FDA approved the device in November 2002, with the FDA requiring the manufacturer to develop a training program for doctors to properly install the device and to report back to the FDA on clinical trials within 5 years. Conceptus missed their 5 year FDA reporting deadline and, in fact did not report until April 2015. Conceptus was purchased by Bayer Healthcare in 2013.
The product is non-surgical and works by inserting metallic coils into a woman’s fallopian tubes through the cervix. The inserts cause irritation of the fallopian tubes, which then create scar tissue which closes off the tubes, preventing passage of eggs. The process takes less than an hour in a doctor’s office to insert and was designed to be irreversible.
The devices are tiny and constructed of nickel-titanium alloys covered by a substance called polyethylene terephthalate. The patient is advised to use another form of birth control for 3 months, while the body closes off the tubes, and then needs to follow up with a radiologist to confirm that the tubes are completely closed off. This is done by inserting dye into the cervix and an X-ray is performed to insure the dye was blocked from passage.
Since market approval in 2002, nearly 750,000 women have had the device installed. Prior to the Bayer buyout in 2013, over 16,000 complaints were filed with Conceptus from 2011-2013. The FDA has received 4,000 complaints, and many are pressuring the FDA to remove this product from the market. In fact, a bill has even been introduced in Congress in 2015, to have the FDA reverse its approval of the product.
Many women have reported immediate abdominal pain after installation of the device, heavier and irregular menstruation, hemorrhaging, headaches, fatigue and weight gain. In some rare cases pregnancy has occurred. It turns out the rate of unintended pregnancy after the installation of the device is about the same as surgical or laparoscopic tubal ligation.
For women with nickel allergies, the device can cause allergic reactions, which include rash itching and hives. Several non-allergic issues have been reported as well including migration of the device, perforating of the fallopian tubes, and implanting in the abdominal wall.
Removal of the device after installation, in most cases, requires surgery. This contradicts one of the primary reasons women may have chosen to use the Essure device to begin with, which was to avoid surgery. Many women have required complete or partial hysterectomies in order to remove the devices from their systems.
If I’ve had problems with Essure, can I sue the manufacturer?
There are several cases against Essure’s manufacturer, Bayer Healthcare, in the court system. These cases have not gone to trial yet and have had no settlements. The Richard Harris Law Firm is investigating potential cases where women have had the Essure devices implanted and encountered serious side effects, such as unwanted pregnancy, additional surgery to have the device removed, migration of the device, or hysterectomy. Call us today to discuss your potential case at (702) 444-4444.