Essure Birth Control Tied to Numerous Side Effects. Essure is a permanent form of female birth control that is constructed with two nickel-alloy metal coils that are inserted into each of a woman’s fallopian tubes. The Essure system prevents pregnancy after the several months it takes for the coils to expand in place and scar tissue grows around the coils forming a natural barrier. This barrier is meant to be a permanent, non-surgical method of birth control for women by preventing sperm from reaching the egg.
The U.S. Food and Drug Administration (FDA) approved Essure in 2002. Bayer marketed Essure as a non-surgical alternative to tubal ligation, a surgical method of permanent birth control. Clinical trials used to approve Essure purportedly lasted one or two years.
The devices have been linked to numerous adverse events including abdominal cramping, migraines, abnormal menstrual bleeding, infections, and allergic reactions. In some cases the coils may break or migrate, puncturing the fallopian tubes or uterine wall. According to the FDA, some of the more common adverse effects of Essure include mild to moderate pain, cramping, vaginal bleeding, pelvic discomfort, and back discomfort. More serious adverse reactions include:
- Abdominal pain
- Back pain
- Device migration through the fallopian tubes into the lower abdomen and pelvis
- Ectopic pregnancy
- Heavy menstrual bleeding
- Irregular menstrual cycles
- Need for hysterectomy
- Pelvic pain
- Perforated organs
- Perforation, puncturing of the uterus or fallopian tubes
- Rash and itching associated with possible nickel allergy
- Unintended pregnancy
- Weight gain
Essure migration and organ perforation are two of the most serious side effects associated with the permanent birth control. Should the Essure birth control implant separate, break, or move it may perforate nearby organs, leading to very dangerous complications, including the need for multiple surgeries, which may require complete removal of the uterus or fallopian tubes.
The personal injury attorneys at Parker Waichman LLP are keeping up-to-date with Essure and other medical device injuries. The firm continues to offer free legal consultations to individuals with questions about filing an Essure lawsuit.
Essure Lawsuits Continue to Rise in Numbers
Earlier this month, 94 women from 32 states were involved in a massive lawsuit brought against Bayer, the maker of Essure, over similar allegations that they suffered serious, sometimes life-threatening side effects. The lawsuit was filed on December 8, 2016 in the U.S. District Court for the Eastern District of Missouri, Eastern Division and also includes allegations that Essure intentionally minimized patient reports of Essure adverse reactions. The lawsuit claims that, from May 2014 to January 2016, Bayer received more than 460 complaints about Essure coils breaking. When Bayer reported the cases of adverse effects of Essure to the U.S. Food and Drug Administration (FDA) the reports were allegedly misleading. The plaintiffs also allege that, had they been sufficiently advised of the complications associated with Essure, they would not have agreed to be implanted with the device.
The lawsuit also alleges that, according to Bayer Healthcare’s advertising and marketing, the Essure system is a safe and effective method of permanent birth control and that the permanent birth control is superior to other options available to women, despite thousands of complaints involving Essure adverse effects.
“Despite knowing about hundreds of instances of the Essure device breaking, Bayer has repeatedly reported to the FDA that only single cases exist. Therefore, when multiple FDA analysts read separate reports that each state ‘single cases have been reported of Essure breakage,’ it causes each individual analyst to falsely believe that instances of device breakage are extremely rare,” according to the complaint. By year-end 2015, approximately 10,000 adverse event reports were submitted to the FDA.
A recent lawsuit alleges that a woman was implanted with Essure in October 2010 and suffered health complications due to a nickel allergy. Her lawsuit indicates that, while she was aware of her nickel hypersensitivity, she alleges that Bayer did not warn her or her physician that nickel is a metal used in Essure. According to her complaint, after the device was implanted, she fainted and received an adrenaline shot. She alleges that she and her physician chose Essure based on representations made by Bayer and that had she or her physician been aware of the presence of nickel in the device, she would have chosen a different contraceptive option. The lawsuit also alleges chronic pelvic pain, multiple fibroids, and nickel poisoning. She had the Essure removed in September 2015 and alleges to continue suffering from complications.
Essure Black Box Warning, Patient Checklist, Bayer Study
In September 2015, the FDA held an advisory panel to discuss safety issues associated with Essure. Women implanted with Essure testified before the panel; Bayer also testified. Panel members asked why Bayer did not collect data that would have helped identify adverse events and said that additional research is needed. In response to complaints involving nickel allergy one physician asked, “How can Bayer and the FDA have no knowledge of nickel allergies?” according to 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 agency should have mandated a randomized clinical trial, considered the so-called “gold standard” in clinical research, prior to 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.”
The agency announced labeling changes for Essure, a boxed warning, as well as a patient checklist. The warning is known as a “black box” and is the FDA’s most serious warning. The new boxed warning advises users about risks for implant perforation, device migration, allergic reaction, persistent pain following the procedure, symptoms similar to autoimmune diseases such as joint pain and fatigue, menstrual cycle changes, and other possible risks. A checklist was added to help ensure patients are aware of Essure’s risks and benefits. The checklist includes information that physicians should review with patients considering Essure and states, among other items, that no form of contraception is 100 percent effective and that the rate of unplanned pregnancy with Essure is less than one percent at five years; however, should pregnancy occur with Essure, there is an increased risk of ectopic pregnancy, which occurs somewhere that is not the uterus, such as the fallopian tubes and is considered a life-threatening condition. Also listed is that the coils have perforated the uterine wall and migrated to other areas of the body in some women. The new label indicates that, should a patient require Essure removal due to a complication, the removal would require surgery, despite that Essure is a non-surgical system.
The actual rate of complications tied to Essure remains unclear, according to The New York Times. When Essure was approved it did not undergo the clinical trial used to gain clearance involving a control group in which a placebo was used. Now, Bayer indicates that it will monitor some 1,400 Essure users over the next five or six years to track side effects. Bayer will also track 1,400 women who opted for laparoscopic surgery, a more traditional means of sterilization. Bayer indicated that it would follow up with the women to compare complication rates, including chronic pelvic pain, heavy bleeding, autoimmune disorders, and unplanned pregnancy.