WARREN, Ohio (WKBN) – The first thing Brandy Woods felt was the bleeding.
It started shortly after Woods, a Warren native and current resident, had a permanent contraception device known as Essure inserted in her in Sept. 2012. Then there was the pain. She had to stay in bed and said that at times, she felt like she was in labor.
Eventually, after consulting with her doctor, she decided her only option was to get a hystorectomy at 29 years of age.
“I wouldn’t put this on my worst enemy,” Woods said. “Not as much issues as I’ve had. I haven’t had a lot like a lot of women have, but I’ve had enough, my fair share.”
Woods is one of over 9,000 women who have banded together as part of a Facebook group called “Essure Problems” to protest problems which they say are caused by the device. The movement has attracted attention, even attracting the support of famous activist Erin Brokovich.
The most common problems reported by recipients of the device are pain, hemorrhage, headache, menstrual irregularities, fatigue, and weight fluctuations, according to an FDA assessment of the device.
Some of the women are working with law firm Koch, Parafinczuk & Wolf to pursue legal action against Bayer, the company that manufactures Essure, according to Woods.
Bayer is protected from class-action lawsuits by the US Food and Drug Administration, meaning the entire group cannot sue Bayer at once, according to Hermitage resident and Essure patient Ruth Ruble. Instead, the law firm is taking clients on an individual basis.
WKBN.com reached out to Bayer and the law firm, with both declining to comment on the lawsuits.
“Run the other way,” Ruble said when asked what she would say to those considering Essure. “Definitely run the other way.”
A Bayer spokesperson declined to comment on whether or not they are paying women who say they have suffered because of Essure.
And while those women decry the use of Essure and even want it banned in some cases, those in favor of the device still tout it as safe and effective.
According to Bayer VP for Medical Affairs for Women’s Healthcare Edio Zampaglione, the number of women who have reported problems is small compared to the hundreds of thousands who have an Essure implant.
“We really believe in this product,” Zampaglione said “The data, the facts continue to support that these adverse events are expected, that the rate that they are occurring at is well within what is expected.”
A statement on the FDA’s website says that, after a review of patient complaints, a five-year study and medical literature, “…none of the…information the FDA reviewed has established a causal connection between Essure and certain reported problems, such as extreme fatigue, depression, and weight gain.”
At least one local doctor agrees with that assessment.
Dr. Michael Abdul-Malak, who practices obstetrics and gynecology in Hermitage, Pa., said that Essure is a reliable device and a real breakthrough in contraception technology.
“It’s very common to attribute symptoms to something that happened previous,” Malak said. “The same is happening with Essure. If anything happens, people attribute it to (Essure).”
But those opinions won’t stop some women from trying to get back at Bayer. Ruble said 120 women from the Essure Problems group got hystorectomies in June. And with legal action just now being filed on behalf of some, it could be awhile before there is any resolution to this saga.
“You’re going to tell me that it’s not enough women?” Woods said of the thousands in the Essure Problems Facebook group. “It wasn’t something that I chose to do…I didn’t choose to go through all the pain and suffering.”