"There's no question there are complications, but there are risks and benefits to everything we do in medicine, and we don't have good data to establish the magnitude of the problem," Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists, told the New York Times.
"Decisions like these should be made based on data that's appropriately vetted, not a series of anecdotal reports," Dr. Zahn added.
But the women of the Essure Problems group would argue that they are the data - data that for a long time has been dismissed and ignored, Ennis said.
"We have 31,000 people on our page, probably 25,000 of them have had the device, have had this experience. Their frustration is no one is looking at their data. Instead the FDA is relying on a clinical trial that followed 200 people for two years for a device that is permanently implanted in the human body, as opposed to data from 25,000 women who are experiencing these symptoms every day," Ennis said.
"Almost 7,000 women on the page have undergone the removal procedure (which almost always requires surgery, often a total hysterectomy). That is a lot of women. I don't think people are voluntarily going in and getting hysterectomies if they're not having a significant amount of discomfort," she said.
The FDA has also ordered Bayer to conduct new clinical studies on Essure. The original clinical trials on the device were considered problematic by critics. No control group was used, and so some side effects experienced by the women in the clinical trials were dismissed as being caused by Essure.
Earlier this year, Bayer agreed to track 1,400 women with Essure over the next 5-6 years, though the study is already delayed. These women will be compared to 1,400 women who chose the sterilization method of laparoscopic surgery.
The Essure Problems women, however, believe that the device should be pulled from the market while clinical trials are still ongoing, Ennis said.
"If you were a woman, would you sign up for this clinical trial?" Ennis said, given the debilitating side effects that thousands of women have experienced post-Essure.
"They know that these women are suffering from these problems, and yet they're going to continue to sell the device until Bayer proves it's not safe," she said.
The Essure Problems women were also concerned that the new FDA label still failed to mention some of the more common side effects experienced by women with Essure, including autoimmune disorders, brain fog, bloating, chronic inflammation, and foreign body reaction, Ennis added.
Nevertheless, the black box warning is an accomplishment for the grassroots organization of Essure Problems, Ennis said.
And the women are not giving up. They will continue to fight, including lobbying Congress for laws that would get rid of pre-emption (which Essure received) and to improve medical device safety and medical device reporting from physicians.
"They're not quitting, but they should be proud of what they've accomplished to date," Ennis said.
"And they won't give up. I know these women, they're very tenacious. They're definitely not stopping."