Essure Birth Control Lawsuit
Almost a dozen lawsuits alleging Essure, a permanent birth control device manufactured by Bayer, caused serious injuries to women, can now move forward thanks to a ruling by a California state court. This particular ruling could have a significant impact for manufacturers who claim that since their products are federally regulated, the manufacturer should not be held accountable for resulting injuries. Although Bayer attempted to have the cases in question thrown out on a variety of grounds, Judge Winifred Y. Smith sided with the plaintiffs.
The eleven consolidated Essure cases represent fourteen women. These women are claiming that Essure, a device comprised of tiny metal coils, which is inserted into the fallopian tubes, left them with serious injuries—far beyond any of the risks mentioned in the Essure literature. More than 200 Essure lawsuits have been filed in the state of California alone, while many others have been filed in both state and federal courts. Bayer’s argument is that since Essure had FDA approval, Bayer should not be responsible for injuries. The California court clearly responded that manufacturers simply don’t have that type of immunity.
What is Essure?
Essure was approved as a Class III medical device in 2002, as a method of permanent birth control. The device is implanted in the fallopian tubes, where the metal coils expand to about an inch and a half, anchoring themselves to the fallopian tube walls. After about three months, scar tissue forms around the metal coils, preventing sperm from reaching a woman’s eggs. The procedure requires no anesthesia or incisions, rather is inserted via a thin metal catheter.
How Many Women Have Been Implanted with Essure?
Since 2002, it is estimated that some three-quarters of a million women across the globe have had an Essure device implanted. The procedure, like a tubal ligation, can be surgically reversed, however the chance of a successful pregnancy after removing an Essure device is only about 29 percent. Further, among women who have had their Essure device removed in order to become pregnant, the uterus is more likely to rupture during the later stages of the pregnancy.
Problems with Essure
Approved as a Class III medical device in 2002, the Manufacturer and User Facility Device Experience Database has had more than 5,000 adverse event reports regarding Essure. These reports range from abnormal bleeding to migration of the device. Of all the adverse event reports received, the following injuries are most common among women who were implanted with an Essure device.
- Severe pelvic pain;
- Severe abdominal pain;
- Internal bleeding;
- Autoimmune problems;
- Patient-device incompatibility due to nickel allergies;
- Perforation of the fallopian tubes;
- Hair loss;
- Device migration;
- Device expulsion;
- Miscarriages, and
Were Essure Study Results Falsified?
Although Essure is a Class III device, it was actually approved for the original manufacturer, Conceptus, through a fast-track process with a caveat: the FDA mandated that Conceptus would follow women in the study for at least 4-5 years, following implantation of Essure. Oddly enough, while the study was complete in 2007, the data was not published until 2015.
At that time, it was of some concern that only about 70 percent of the women were actually followed for the full five years. Further, several women came forward to say that the results of the Conceptus study were falsified. When the FDA investigated, it found at least six cases of potential tampering, yet the FDA called that tampering “sporadic” and saying it “did not reveal a pattern.”
Deaths Associated with Essure
There have been 26 deaths which were linked to the use of Essure—four deaths of adult women, 18 lost pregnancies, and two infant deaths after a live birth. The adult women reportedly died from uterine perforation, infection and air embolism. In 2015, a panel of independent experts was convened by the FDA. These experts recommended the FDA limit the use of Essure, then later, in February 2016, the panel recommended a black box warning for Essure.
Many are calling for a total recall of Essure, claiming too little research was done to prove the safety of the device. Five federal Essure cases charged Bayer with negligent misrepresentation and negligent failure to warn. Other charges such as breach of express warranty, negligent manufacture, fraudulent representation and negligent risk management were dismissed. The California lawsuits claim there was a failure to monitor and test Essure, as well as to exercise reasonable care in its manufacturing and quality control process, conduct regular risk analysis, or even to appropriately train and certify physicians. This latest California ruling will likely open the door for many more Essure lawsuits in the near future.