FDA Orders ‘Black Box’ Warning for Essure Sterilization Device

Regulators Add Essure Boxed Warning, Patient Checklist

Last week, the U.S. Food and Drug Administration (FDA) announced that Essure, the female sterilization device manufactured by Bayer, will carry a boxed warning or “black box” warning. The agency ordered the label update after a number of women complained of adverse events. The new warning label for Essure warns about the risk of implant perforation, device migration, allergic reaction, pain and other potential risks. In addition to the boxed warning, the FDA also directed Bayer to produce a patient checklist for physicians to review with patients before implanting 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.
Last month, the agency released a final, nonbinding guidance on the boxed warning for Essure along with a patient checklist. The FDA says it approved the new label on Nov. 15 “which is consistent with the recommendations of the final guidance.”

“The FDA expects Bayer to make the updated Essure product labeling available within 30 days following the FDA’s approval decision,” regulators said. “A link to the new, approved labeling will be provided on this website as it becomes available on Bayer’s website.”

The boxed warning says that some women have experienced serious complications associated with Essure. Adverse events include 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. Although Essure is non-surgically implanted, if patients experience an adverse event where the device needs to be moved then surgery would be required.

The three-page patient checklist is a way for doctors to thoroughly review the risks of Essure with the patient. Among other things, the list informs patients 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. The checklist informs patients that, if pregnancy does happen to occur when Essure is implanted, it is more likely to be ectopic. An ectopic pregnancy is when implantation occurs outside the uterus; it is a life-threatening condition. Essure consists of two metal coils in the fallopian tubes. The checklist warns patients that in some women, these coils have poked through, or perforated, the wall of the uterus and moved to other locations in the abdomen or pelvis; this complication is known as migration. Common adverse events that tend to occur after Essure is implanted 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.

Parker Waichman notes that Essure safety concerns rose after thousands of women began complaining of complications, mostly through social media. The movement grew, prompting the FDA to hold an advisory panel meeting in September in which experts heard testimony from women who say they were injured by Essure. The panel also heard arguments from Bayer. The New York Times interviewed one of the women who testified before the panel. She says she experienced severe pain after being implanted with Essure, so the coils were removed. She says the pain persisted afterwards for another three years, feeling relief only when she had a hysterectomy.

“Doctors kept saying there was nothing wrong with me,” said the woman, 53, to NYT. “I knew, with every fiber of my being, there was still something there.” It turns out that, even though the coils were removed a piece of the metal device had been embedded in her uterus. Bayer says complications such as this are a result of poor surgical skills. Women who testified before the panel, however, felt the device needed to be pulled from the market altogether.

According to NYT, the true rate of complication with Essure is unclear. The original clinical trial to approve the device did not have a control group taking a placebo, which is the standard drugs must meet to gain clearance. Bayer agreed to track some 1,400 Essure users over the next five or six years to monitor adverse events. The company will also track 1,400 women who opted for laparoscopic surgery, a more tradition 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

Essure has been on the market since 2002. The device, which was marketed as a non-surgical alternative to tubal ligation (known colloquially as getting “tubes tied”) consists of two metal coils inserted into each fallopian tube. As scar tissue grows around the coils, sperm is blocked from fertilizing the egg, preventing contraception. Essure was approved based on clinical trials lasting a year or two. The device is meant to be permanent.

By the end of 2015, the FDA received nearly 10,000 reports of adverse events associated with Essure. Women also took to social media, particularly through a Facebook group called “Essure Problems”, to share stories of complications. In September 2015, the FDA held an advisory panel to consider the risks and benefits of Essure. The expert panel heard testimonies from women affected by Essure, and also from Bayer itself. Some panel members criticized Bayer for failing to collect data that could have identified risks, and called for more research.

For example, some women complained that Essure caused an allergic reaction due to the presence of nickel. 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).

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