Bayer Faces New Lawsuit over Essure Permanent Birth Control Device
A new lawsuit has been filed alleging injuries from Essure, the female sterilization device marketed by Bayer. The plaintiff alleges that she suffered from complications due to a nickel allergy. According to her lawsuit she was aware of her hypersensitivity to nickel, but alleges that Bayer did not inform her or her physician about the presence of nickel with Essure.
The personal injury 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.
Essure consists of two metal coils inserted into the fallopian tubes. The system prevents pregnancy as scar tissue grows around the devices. Essure is meant as a form of permanent, non-surgical birth control for women.
The plaintiff was implanted with Essure in October 2010. According to her complaint, she suffered heavy bleeding and severe pain. She fainted after the device was implanted, and received an adrenaline shot. The plaintiff says she and her physician chose Essure based on representations made by Bayer. According to the complaint, she has a known nickel sensitivity, but neither she nor her doctor knew that Essure contained nickel. She alleges that she would have chosen a different contraceptive option if she were fully informed. The lawsuit alleges chronic pelvic pain, multiple fibroids and nickel poisoning.
The plaintiff had Essure removed in September 2015. Allegedly, she continues to suffer from complications. She alleges that Bayer failed to warn of the side effects.
FDA Adds Boxed Warning, Patient Checklist for Essure
The U.S. Food and Drug Administration (FDA) recently announced labeling changes for Essure, adding a boxed warning and patient checklist. The boxed warning, also known as a “black box” warning, is the FDA’s most serious type of warning. The new boxed warning informs users about the risk of implant perforation, device migration, allergic reaction, pain and other potential risks.
A new Essure checklist was also added, helping to ensure that patients know about the risks and benefits.
The new boxed warning warns that some serious adverse events have occurred in women implanted with Essure, including the device perforating the uterus and/or the fallopian tubes, persistent pain after the procedure, changes in their menstrual cycle, allergic reactions and symptoms similar to autoimmune diseases such as joint pain and fatigue. The label states that if patients need Essure to be removed due to a complication, surgery would be required even though Essure a non-surgical system.
The checklist provides items that physicians should review with patients considering Essure. The list states, among other things, that no form of contraception is 100 percent effective. The rate of unplanned pregnancy in women with Essure is less than 1 percent at 5 years. If pregnancy does occur with Essure, there is a higher risk that the pregnancy will be ectopic. An ectopic pregnancy is when implantation occurs somewhere other than the uterus, such as the fallopian tubes. Ectopic pregnancies are considered a life-threatening condition.
The checklist also discloses that, in some women, the coils have perforated the wall of the uterus and migrated to other locations in the body. After Essure is implanted, common side effects include pain, cramping, nausea, dizziness and vaginal bleeding. These adverse events and more are given to patients so that they can make a fully informed decision.
The true rate of complications associated with Essure is unclear, the New York Times reports. When Essure was approved, the clinical trial used to gain clearance did not have a control group taking a placebo; this is a standard drugs must meet to gain clearance.
Bayer says it will monitor some 1,400 Essure users over the next five or six years to track side effects. As a comparison, the company will also track 1,400 women who opted for laparoscopic surgery, a more traditional means of sterilization. Bayer will follow up with the women to compare rates of complications such as chronic pelvic pain, heavy bleeding, autoimmune disorders and unplanned pregnancy.
Essure Permanent Birth Control Background
The FDA approved Essure in 2002. Bayer marketed the device as a non-surgical alternative to tubal ligation (known colloquially as getting “tubes tied”). The scar tissue growing around two metal coils blocks fertilization in the fallopian tubes. Clinical trials used to approve Essure lasted a year or two. Essure is designed to be a permanent, sterilization device.
Essure came under increased scrutiny following complaints from users. Some 10,000 adverse event reports were submitted to the FDA by the end of 2015. Concerns also gained attention through social media, particularly through a Facebook group called “Essure Problems”. Members of the group joined to share stories of complications believed to be associated with Essure.
In September 2015, the FDA held an advisory panel to discuss Essure safety issues. Women implanted with the device testified before the panel about their stories. Bayer also testified. Some panel members questioned why Bayer did not collect data that would have helped identify adverse events. They also said more research was needed.
Bayer also faced criticism. For instance, some of the complaints stem from a nickel allergy. In response to this, one physician said “How can Bayer and the F.D.A. have no knowledge of nickel allergies?” said Massachusetts General Hospital dermatologist Dr. Peter Schalock. “Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data?”
Other experts said the FDA should have required a randomized clinical trial, the gold standard in clinical research, before approving Essure. “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 the agency “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 birth control 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).