Boxed Warning Added to Essure Safety Information, FDA Says

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Essure Black Box Warning Includes Risk of Perforation, Migration

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that is has approved a label update for Essure, the permanent birth control device manufactured by Bayer. The new label will carry a boxed warning, also known as a black box warning, that informs consumers about the risk of implant perforation, device migration, allergic reaction, pain and other potential complications. The boxed warning, which is the agency’s most serious type of warning, was issued in response to thousands of consumer complaints.

Parker Waichman LLP personal injury attorneys are offering free legal consultations to anyone who has questions about filing an Essure lawsuit against Bayer.

Regulators issued a final, nonbinding guidance on the boxed warning for Essure and a patient checklist last month. The FDA said it approved new labeling 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,” the FDA says. “A link to the new, approved labeling will be provided on this website as it becomes available on Bayer’s website.”

The new warning discloses that some women have reported serious complications associated with the use of Essure, such as the coils poking through the fallopian tubes or uterus, 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 boxed warning also says that if patients do experience an adverse event where Essure needs to be removed, surgery would be required.

The patient decision checklist is intended to make sure women fully understand the risks and benefits of Essure before undergoing the procedure. According to the checklist example listed in the FDA guidance, the decision checklist ensures patients know that no form of birth control is 100 percent effective; clinical studies show that the rate of unplanned pregnancy with Essure is less than 1 percent at 5 years. Furthermore, patients are informed that if pregnancy does occur with Essure, it is more likely to be an ectopic pregnancy. An ectopic pregnancy is when implantation occurs outside the uterus; it is a life-threatening condition. The checklist also ensures patients understand that Essure has a risk of poking through, or perforating, the wall of the uterus and moving to other locations in the abdomen or pelvis (migration). Patients are also told about common side effects that occur immediately after implantation, such as pain, cramping, nausea, dizziness and vaginal bleeding. This information and more is given to patients so that they can make a fully informed decision.

Essure Sterilization Device Background

The FDA approved Bayer’s Essure permanent birth control in 2002. The sterilization device 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 marketed as a non-surgical means of permanent birth control.
Essure came under scrutiny following reports of adverse events. Essure complaints gained momentum through social media, particularly through a Facebook group called “Essure Problems”. 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. The medical advisers criticized Bayer for failing to collect data that could have identified risks, and called for more research.

One physician, for instance, brought up the fact that Essure contains nickel, which can lead to an allergic reaction in some women. “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?”

Some panel members said the FDA should not have approved Essure without a randomized clinical trial, the gold standard in clinical research. “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).