SILVER SPRING, Md. — A panel of experts convened by the Food and Drug Administration excoriated the manufacturer of a contraceptive device for not collecting data that they say could have helped predict risks for women. The device has received thousands of complaints from women who say they were harmed by it.
The device, called Essure, is a small metal and polyester coil implanted into a woman’s fallopian tubes to make her permanently sterile. The F.D.A. approved Essure 13 years ago after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.
But since then, allegations that the device has caused severe pain, perforations of fallopian tubes and possibly even death, have accumulated, and the agency decided to hold a daylong public meeting on Thursday to talk about them. The F.D.A. does not have to take the advice of its expert panels, but it often does.
Perhaps most troubling was an account by Gabriella Avina, who said she had taken part in the original clinical trials and had worked for the company, explaining the device to women when it first came on the market.
“I am here today, almost 13-plus years later, to say I was wrong,” Ms. Avina said. “Time has changed my thoughts, beliefs and, most importantly, my health.” She said her health had deteriorated badly since she had Essure implanted. She was found to have celiac disease, a thyroid disorder and myasthenia gravis, illnesses that required multiple hospitalizations, chemotherapy and transfusions.
“My health was in a tailspin, and I had failed to connect the dots,” she said. “The only foreign object in my body was the coil.”
Some experts have called for more studies, saying the device had simply been poorly tracked after it came to market, with some women who had experienced problems left out of final results. But the women in the room rejected that recommendation, saying the device had harmed enough women — they said 21,000 were now part of their Facebook network — that it should be recalled.
Diana Zuckerman, the president of the National Center for Health Research, which has been tracking the device, said some women participating in the clinical trials had evidence that their answers were changed by clinical investigators to make their response seem rosier — an accusation that Steven Immergut, a Bayer spokesman, denied. […]
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