Thousands of injuries have been reported to the Food and Drug Administration (FDA) from the sterilization device Essure since its approval in 2002. Recently, the FDA™s panel on Obstetrics and Gynecology met to discuss the safety of Essure and how doctors and patients can best avoid serious complications. Our team of dangerous medical device lawyers details this meeting below.
Essure is a metal and polyester coil manufactured by Bayer. It is implanted in women who have already had children and are looking for permanent birth control (also called sterilization). Essure is implanted into the fallopian tubes through the uterus using a catheter, leaving the tip of the device just outside the organ so its placement can be visually confirmed.
After implantation, it takes the body about three months to grow tissue around the coils to form a natural barrier, blocking sperm from entering. Essure is the only nonsurgical permanent birth control option approved by the FDA, making it an appealing choice for many women looking for a faster and easier alternative to surgery. Unfortunately, Essure comes with its own severe, debilitating side effects that far too women were never informed of.
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Essure can cause a variety of complications, including heavy bleeding, depression, hair loss, chronic pain, migraines, psoriasis, perforation of the uterus, and fatigue. It can migrate out of its implanted position, cutting through nearby organs and requiring painful emergency surgery. Many women even have a difficult time finding a doctor willing to remove Essure implants.
The device is more dangerous for women whose fallopian tubes are not completely straight. Other patients not well-suited for the device include those with auto-immune disorders, a history of abnormal uterine bleeding, chronic pelvic pain, hypersensitivity to nickel or other metals, and those with pelvic inflammatory diseases.
More than 5,000 Essure complaint reports have been filed with the FDA to date.
FDA Meeting Notes
On Thursday, September 24, 2015, the FDA™s Obstetrics and Gynecology Devices panel spent hours discussing Essure patient complaints and injury reports, medical studies, and post-marketing data. There was a public discussion portion, during which more than 30 women spoke about the severe problems they experienced from Essure.
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One of these women, Rebecca Howell, had Essure implanted in 2011, later suffering from migraines, heavy and painful bleeding, hair loss, nickel sensitivity, back pain, and chronic fatigue. She said the device made her feel like œless of a human. Another woman, Tisha Scott, suffered excruciating pain that left her unable to get out of bed. She underwent two surgeries, countless exams, and still lives in constant pain.
In efforts to make the device safer, panel members suggested Bayer create a new label for the device, establish more comprehensive instructions for insertion and monitoring, increase collection of data, and strengthen patient education.
Panel members also recommended that Bayer:
- Create an informed consent document, so patients are aware of the risks, benefits
alternatives before agreeing to implantation.
- Develop training for proper placement and removal.
- Develop a registry to track patient complications.
- Establish guidelines for doctors to identify long-term complications earlier.
The head of the National Center for Health Research told NPR that Bayer failed to fully inform the FDA about Essure™s complications when it was approved in 2002. This organization and other advocacy groups want to see new research that accurately reflects the rate and severity of complications and how often the device fails. Recent research suggests Essure may fail about 10% of the time.
About 750,000 Essure devices have been implanted since its approval. If you or someone you love suffered serious complications from this device, contact our team of defective medical device lawyers immediately. We have been fighting on behalf of injured patients for 30 years, and provide free legal consultations to concerned patients and families nationwide.