FDA Issues New Warning About Essure Birth Control Implants

After receiving thousands of complaints from women about bleeding, chronic pain, and other adverse health issues, the U.S. Food and Drug Administration (FDA) recently required its strongest possible health warning for the Essure contraceptive implant.

What is Essure?

Manufactured by Bayer, Essure is a non-surgical, permanent birth control device. It consists of two nickel-titanium coils inserted into the fallopian tubes, where they spur growth of scar tissue and prevent sperm from fertilizing a woman’s eggs. According to Bayer, approximately 750,000 women have received the device since it came on the market in 2002.

What are the Problems with Essure?

The FDA has been investigating complaints involving Essure over the past several years. Health problems associated with Essure include:

• persistent pain
• perforation of the uterus and/or fallopian tubes
• intra-abdominal or pelvic device migration
• abnormal or irregular bleeding
• allergy or hypersensitivity reactions
• failure of the device resulting in unintended pregnancies.

So Has the FDA Recalled Essure?

No; Essure remains on the market and has not been recalled by the FDA. “The agency continues to believe the product should remain available to women who are informed of the risks,” said Dr. William Maisel, deputy director for science at the FDA’s center for devices and radiological health.

As such, the FDA is requiring that “a boxed warning and Patient Decision Checklist be added to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device.”

This kind of warning is known as a “black box” warning. A “black box” warning is the strongest possible warning the FDA can require a drug or device to have on its packaging, advising consumers about serious side-effects and life-threatening risks associated with the drug.

Additionally, the FDA issued a checklist for doctors to use in discussing the risks with patients and directed Bayer to conduct a clinical study to further evaluate the product’s safety and effectiveness.

The Parian Law Firm: Metro Atlanta Defective Medical Device Lawyers

If you have suffered adverse health consequences as a result of using Essure, you may have a claim for compensation. The Parian Law Firm represents individuals in Georgia and across the country who have been injured and families who have lost a loved one as a result of a defective or dangerous drug or medical device. We are committed to holding the manufacturers of defective devices such as Essure responsible for the damage they cause, and are passionate about obtaining compensation and justice for our clients.

If you or a loved one have questions or concerns about adverse health effects from using Essure, please give us a call at (770) 727-5550 or chat live online with a member of our staff today. We can discuss your situation, evaluate your potential claim, and advise you of your options. We look forward to assisting you.