The U.S. Food and Drug Administration (FDA) has announced that it will require Bayer’s Essure permanent contraceptive to carry a boxed warning and patient decision checklist. A black box warning is the strongest warning allowed by law.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after receiving the Essure birth control device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
November 3, 2016 – Essure’s labeling will now carry a warning about adverse events associated with the contraceptive, including perforation of the uterus and/or Fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. The warning will also state that if the device needs to be removed to treat a complication, surgery will likely be necessary.
The Patient Decision Checklist, which is to be signed by both the patient and the doctor, details:
- The risks and benefits of Essure birth control;
- Other contraceptive alternatives;
- Requirements for Essure placement;
- Pregnancy risks with the device;
- What to expect during and after the procedure based on clinical studies, and
- Long-term risks.
The new labeling requirements follow years of controversy over Essure, which is currently the only permanent birth control option for women that can be performed without surgery.
In September 2015, the FDA Obstetrics and Gynecology Devices Panel reviewed the safety of Essure after receiving over 5,000 complaints from recipients. The panel agreed that there was a lack of data about risks of the contraceptive and that patients needed better counseling before electing to undergo the procedure.
The updated labeling seeks to address some of those concerns:
“FDA believes this will help to ensure a woman receives and understands the benefits and risks associated with her contraceptive options so that she can make an informed decision as to whether a permanent hysteroscopically placed tubal implant intended for sterilization is the right choice for her,” the agency said in its final guidance on Oct. 28.
In September 2016, FDA approved an Essure postmarket surveillance study to be conducted Bayer. The 3-year study will compare safety and effectiveness between women who undergo hysteroscopic sterilization with Essure and those who have laparoscopic tubal sterilization (“tubes tied” surgery).
Do I Have an Essure Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you experienced problems after being implanted with the Essure contraceptive, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.