It’s taken 9,000 adverse event reports for the FDA to review the safety and efficacy of Bayer’ Essure® device.
On Monday, October 31, 2016, the FDA issued guidance for Essure® labelling components (black box warning) and a patient decision checklist. Black box warnings from the FDA are the most severe warnings given out, and are intended to alert the consumer to the risk of serious or life-threatening injury.
Essure® is marketed by its maker, Bayer, as a 10-minute outpatient procedure for busy women with less pain and a faster recovery time than tubal ligation. As we wrote about in a previous Essure® blog – opting for a non-surgical procedure doesn’t mean you won’t end up on the operating table.
Is the FDA doing too little too late?
The message we gathered from reading posts online conveys a lack of confidence in the FDA.
- By December 2015, over 9,900 women reported chronic pain, bleeding, organ damage, and other side effects due to Essure®.
- Between November 2002 and May 2015, more than 5,000 women filed reports with the FDA, regarding unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding after Essure® was implanted.
- U.S. Rep. Mike Fitzpatrick, a Pennsylvania Republican, and analyst Madris Tomes founder and chief executive officer of Device Events, presented data showing more than 300 possible fetal deaths linked to Essure® when the FDA previously only reported five total deaths.
FDA Final Guidance: Essure® Warning Label
- The label addresses adverse experiences and events 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 label addresses that if a woman needs the device removed a surgical procedure will be required.
- FDA Example of Essure® Black Box Warning:
“WARNING: Some patients implanted with the Essure® System for Permanent Birth Control have experienced and/or reported adverse events, 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. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure® System for Permanent Birth Control during discussion of the benefits and risks of the device.”
This checklist highlights possible side effects from Essure® and must be signed by the woman and her doctor before Essure® is implanted.
This is your opportunity to voice your opinions, experiences and complaints. Please keep in mind, comments may not be acted upon by the Agency until the document is next revised or updated.
- Contact the FDA:
- Online: Electronic comments and suggestions may be submitted to http://www.regulations.gov
- U.S. Mail: Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2015-D-4803.
- Sign a Petition:
Erin Brockovich (yes, the Erin Brockovich) has petition urging the FDA to stop or remove Essure® from the market. You can also contact your local congressman and express your concerns about Essure®.
Contact A Lawyer:
Contact a lawyer: If you or someone you know has been injured by the Essure® birth control device contact d’Oliveira & Associates for a free (no obligation) case evaluation. Call us toll free at 1-800-992-6878 or fill out our contact form online.
Sources: FDA.gov, NPR, Drugwatch.com