TAMPA, Florida - An FDA-approved birth control device -- offered by doctors as an easy, non-surgical procedure -- has been drawing an increasing amount of criticism as more patients are coming forward and reporting unbearable side effects.
Essureis a metal coil that gets inserted into a woman's Fallopian tubes. The body's tissue then bonds with the device, blocking conception permanently.
While the majority of the 750,000 women who have had the procedure report success, a vocal minority are banding together on a Facebook page, "Essure Problems," with the hope of getting the product re-classified by the FDA.
Their complaints range from abdominal/pelvic pain to drowsiness to hemorrhaging. Upset patients include Heather Hare, 45, from Pasco County. The motherof one thought the procedure would be a quick and affordable alternative to getting her tubes tied, but after three years of problems she associates with the device, she had a complete hysterectomy in 2013 to remove it.
"I had a lot of pelvic pain (and) pressure below," Hare said, adding she was often tired and confused as well. "I was always in a fog very forgetful ... by noon every day it was just exhausting."
Hare isn't sure what the device was doing to her body, but said she felt great following the hysterectomy.
"It was like night and day," she said.
Hare thought her symptoms were just due to aging, but decided to Google "Essure Problems" one day and found the Facebook page. She said it was transformative.
The online group now has around 6,000 members, where women regularly share pictures and painful stories about recent health problems since getting the Essure implant. Many suspect a nickel allergies from the coils.
The 10 Investigates team spoke to doctors, including USF Health and Tampa General Hospital OBG/YN Dr. Catherine Lynch, about the device.
"It's not one-size-fits-all," Lynch said. "You really have to know the product. You need to be asking questions ... what are my options? Pros and cons?"
Lynch said research and open discussion with your doctor is incredibly important since previous health issues such as injuries, sexually-transmitted diseases, or allergies could all causeunwanted side effects withEssure.
Compounding the women's frustrations is the fact that they cannot sue due to Essure's "preemption status," granted by the FDA when it was approved more than a decade ago.
However, famed attorney Erin Brockovich has joined the cause, seeking to bring women together to potentially get the product removed from the market.
Bayer, the corporation that recently acquired Essure, provided a statement to 10 Investigates:
Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure's safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control.
As part of our commitment to patient safety, we continuously monitor and review the safety profile of our products worldwide. No safety signal has been observed for Essure that would change our position that Essure has a favorable benefit-risk ratio. Drug related adverse reports are consistent with those seen in clinical trials and reported in long-term study. I strongly encourage you to reach out to the US Food & Drug Administration (FDA) for the most current, and most complete, information available regarding adverse events.
The FDA reviewed, among other things, the results from a five-year Essure study late last year. The FDA found that "[a]lthough there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known."
The full FDA report can be found here.
In addition, a recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopic tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements.
No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.
Bayer also provided a video statement from Edio Zampaglione, MD that said, "We are saddened to hear of any patient who has been harmed by any of our products, regardless of the cause ... Essure is one of the most effective contraceptives, and has been on the market for 10 years."
To watch the entire Bayer video statement click here.