San Diego, CA September 3, 2015 — Women, like Kama Sales, were attracted to Essure because of the marketing that it’s a simple procedure with a quick recovery. Kama Sales has a busy life and decided that she no longer wanted any more children, so she had Essure implanted.
“What caught my attention was that there was no down time,” she said. “It was easy-in, easy-out. I could have it done on Friday and be at work Monday.”
Unfortunately, that’s not how Kama’s story went. She described the procedure as “extremely” painful, and experienced heavy bleeding for a month. Not only did she have joint pain, she gained nearly 70 pounds.
“I signed up to not have any more children, not to live in pain.”
Back in 2013, Sales was forced to have a complete hysterectomy to remove the device. She is just one of thousands of women faced with the choice of a hysterectomy to ease their pain and suffering.
To add to the torture, Bayer, the manufacturer of the device, currently offers doctors no specific training on how to remove Essure. Problems that have developed from the device could have more to do with the doctors’ skills and competency in working with Essure. Dr. Edio Zampaglione, vice president of medical affairs for women’s health at Bayer, writes:
“We are not in the business of training physicians. Those are skills the physicians should already have.”
An estimated 750,000 women worldwide have had the Essure device implanted and there have been more than 5,000 reports of adverse events (side effects) related to Essure. Here are all of the adverse events reported to the FDA related to Essure:
Abdominal pain: 3,353
Heavy or irregular menstrual cycles: 1,408
Incompatibilities (allergies): 941
Weight fluctuations: 836
Device migration: 482
Broken device: 259
Bad positioning of device: 133
FDA’s Response to Essure Complications
Last month, the FDA issued an alert after a search of the agency’s Manufacturer and User Facility Device Experience, or MAUDE, database found over 5,000 reports of adverse events related to the device. The database includes reports of unintended pregnancies, complications during removal, including air embolism, and five fatal deaths after Essure failed to prevent pregnancy.
The database also includes reports from women who claim they visited multiple doctors who offered varying approaches for removing Essure. The original label for the device noted the lack of data on the safety and effectiveness of surgery to remove the device.
Recently, the FDA updated the potential risks of the device on its website. In addition, they scheduled a public meeting for September 24th, 2015, in Washington of its Obstetrics and Gynecology Devices Panel. This hearing will bring together doctors, researchers, patients and industry advocates to review the safety and efficacy of the device.
The FDA asked the committee to provide recommendations regarding proper use, product labeling and the possible need for additional post-market clinical studies.
We hope the meeting on September 24th will bring the several complications from the Essure device to the forefront for the FDA.
Source: Modern Healthcare