Essure Permanent Birth Control
Approximately 750,000 women have been implanted with Essure for permanent birth control since it was approved by the FDA in 2002. Essure is a permanent birth control device that does not require surgery. Unfortunately, some women have suffered serious complications including persistent pain, perforation of the uterus or fallopian tubes from migration of the Essure device, abnormal bleeding, and allergy/hypersensitivity reactions possibly related to nickel.
Reports of Essure complications reported to the FDA in recent years include the following medical problems:
- Additional surgeries, including hysterectomy, to remove the device and repair internal organs
- Autoimmune response to the device, including fatigue, rashes, hair loss and weight gain
- Chronic pelvic pain
- Unintended pregnancy
- Life-threatening ectopic pregnancy
- Migration of the device or a device component
- Abnormal bleeding
- Perforation or tear of pelvic organs, including uterus or colon
- Severe migraines and allergic reactions
What is Essure?
Manufactured by Bayer, Essure is a small implantable birth control device. The Essure procedure does not require an incision and is implanted in an office setting. The Essure device is a tiny metal spring-like device with synthetic fibers that is implanted by a doctor into the fallopian tubes. Woman can usually go home within an hour after the device is implanted. Then, over a period of about three months, tissue forms around the Essure device. Ultimately, the tissue creates a barrier which blocks sperm from reaching the eggs, thus preventing pregnancy.
February 2016 FDA Safety Update on Essure
On February 29, 2016, the FDA announced that a new, mandatory clinical study would be required for Essure. This announcement comes after thousands of complaints have been received by the Agency in recent years. The FDA ordered Bayer to conduct a new post-market surveillance study that will provide data to help the FDA better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how the side effects impact a patient’s quality of life. Additionally, the study will collect information to identify why some patients do not have a follow-up test to confirm that Essure has been properly placed three months after insertion. The FDA will use the results of this study to determine if any further actions related to Essure are needed to protect public health.
The FDA also indicated that it will require changes to product labeling to include a “boxed warning” and a “Patient Decision Checklist” so women receive and understand risks of this type of device.
September 2015 Advisory Committee Meeting on Essure Safety
On September 24, 2015, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to examine safety concerns about Essure. The Advisory Committee meeting "Executive Summary" can be read here, and the panel transcript can be read here. The Panel heard from medical experts and from women implanted with the Essure device. Some women reported pain and other health problems after Essure implantation that are not included in the product labeling, were not observed in post-approval studies, or described in the clinical literature. Examples include extreme fatigue, depression, weight gain, allergy/hypersensitivity reactions. Many of these outcomes were discussed at the Advisory Committee meeting and cited in docket comments that you can read in the links above.
Panel members urged the FDA to add a “boxed warning” and “Patient Decision Checklist” to the product labeling for Essure to help ensure that a woman receives and understands information regarding the benefits and risks of the device. Following the Panel meeting, the FDA ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks. More information about the Agency’s case report form analysis can be found in the Summary and Key Findings document here.
Tampa Essure Attorney
If you or a loved one underwent the Essure permanent birth control procedure and experienced a severe complication from the device, please contact the law firm of Alley, Clark & Greiwe.
Consumer Information on Essure
Click here to read the FDA's Announcement from February 2016
Click here to read the transcript of the Advisory Committee meeting in 2015