Class Action Lawsuit Filed over Essure Sterilization System
Dozens of women have filed a class action lawsuit alleging that Essure, the female sterilization device marketed by Bayer, caused serious injuries. The class action lawsuit adds to the mounting Essure litigation, as individual lawsuits have also been filed. Plaintiffs allege that Bayer failed to warn patients and the medical community about the risks associated with Essure, marketed as a non-surgical way to permanently prevent pregnancy in women.
The product liability attorneys at Parker Waichman LLP are keeping up-to-date with Essure and other medical devices. The firm continues to offer free legal consultations to individuals with questions about filing an Essure lawsuit.
Most Essure lawsuits were filed individually, meaning they typically represent one plaintiff (and perhaps their partner). A class action lawsuit represents numerous plaintiffs in one lawsuit filed against a common defendant.
Bayer marketed Essure as a non-surgical option for women who no longer want to have children. The surgical alternative is called tubal ligation, colloquially referred to as getting the “tubes tied”. Essure consists of two metal coils, one inserted into each fallopian tube. The system is designed to prevent conception as scar tissue grows around the coils, blocking sperm from reaching the egg.
Essure lawsuits allege complications such as unintended pregnancy, allergic reaction, pain, device migration and other complications. Plaintiffs allege that Bayer failed to disclose the risks.
Despite its efforts, Bayer has been unable to avoid Essure litigation. The company tried to dodge lawsuits by arguing that plaintiffs’ injury claims were pre-empted by federal law. Bayer essentially argued that Essure users cannot sue for injuries because the device was approved by the U.S. Food and Drug Administration (FDA). Bayer has also tried to dodge litigation by placing blame on physicians.
However, Parker Waichman notes that Essure lawsuits have been upheld in court. According to court records, judges in both Illinois and California have ruled that Essure injury claims are not pre-empted by federal law.
One woman recently filed an Essure lawsuit alleging complications from a nickel allergy. She alleges that neither she nor her doctor was informed about the presence of nickel in Essure. According to the complaint, filed in the Superior Court of California, Orange County, she was implanted with Essure in October 2010. The plaintiff knew she had a hypersensitivity to nickel and alleges that she would not have chosen Essure if she knew it contained the metal. Her lawsuit alleges heavy bleeding and severe pain, allegedly due to Essure. She also states that she fainted after Essure was implanted, and injected with adrenaline. The lawsuit alleges that Essure caused chronic pelvic pain, multiple fibroids and nickel poisoning. The plaintiff had Essure removed in September 2015.
FDA Updates Warning on Essure, Following Injury Reports
In November 2016, the FDA announced new changes to the Essure label and safety information. The agency approved a new boxed warning, also known as a “black box” warning that includes information about reported adverse events. Essure will also include a new patient checklist so patients can fully understand the risks and benefits before deciding.
The black box warning discloses reports of implant perforation, device migration, allergic reaction, pain and other potential adverse events. The Essure label includes information about perforation, where the coil pokes through the uterus or fallopian tubes, along with persistent pain after the procedure, changes in the menstrual cycle, allergic reactions and symptoms similar to autoimmune diseases such as joint pain and fatigue. The new label also informs patients that surgery is most likely required if Essure must be removed due to complications, even though the system is implanted non-surgically.
The checklist seeks to inform patients about all the potential risks so that they can make a fully informed decision. Among other things, the document tells users that no form of contraception is 100 percent effective; with Essure, clinical studies show that the rate of unplanned pregnancy is less than 1 percent at 5 years. Additionally, patients are told that if pregnancy does occur after Essure is placed, there is a higher chance of an ectopic pregnancy. An ectopic pregnancy is a life-threatening condition where implantation occurs outside the uterus.
Migration is another potential adverse event disclosed in the patient checklist. This is when the coils of Essure perforate the wall of the uterus and move to another area of the body. Essure may ultimately end up in the abdomen or pelvis, for example.
Common side effects that can occur after Essure implantation include pain, cramping, nausea, dizziness and vaginal bleeding.
To detect any adverse events related to the use of Essure, Bayer will be following roughly 1,400 women implanted with Essure for the next five or six years. The rate of complications in these women will be compared to 1,400 women who were sterilized via laparoscopic surgery. Bayer will be analyzing the rate of complications such as chronic pelvic pain, heavy bleeding, autoimmune disorders and unplanned pregnancy between these two groups.
The FDA approved Essure as a non-surgical female sterilization device in 2002. It is the only device of its kind to be marketed in the United States. Essure was cleared through a fast-track review process; its approval was based on clinical trials lasting one or two years.
The FDA has received a growing number of injury reports related to Essure. Over 10,000 Essure adverse event reports had been submitted to the agency by the end of 2015. Reports of Essure injuries were also shared through social media, primarily through a Facebook group called “Essure Problems”.
In light of injury reports, the FDA held an expert advisory panel in September 2015. Both Essure patients and Bayer testified before the panel of experts. Some members of the panel criticized Bayer for failing to collect data on side effects. Additionally, experts also commented on clinical trials used to approve Essure, stating that a randomized clinical trial, the gold standard in clinical research, should have been conducted. “It was a mistake not to have done so,” said University of Wisconsin’s Richard J. Chappell. “We find ourselves 13 years after it was approved by the FDA asking about pain.” Chappell called on regulators “to live by its own standard, which is a randomized controlled trial.
Filing an Essure Lawsuit
If you or someone you know suffered injuries after receiving Bayer’s Essure permanent sterilization device, you may have valuable legal rights. Our personal injury attorneys offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).