The device is a small metal and polyester coil placed into a woman’s fallopian tubes in order to make her permanently sterile.We all understand the fallopian tubes are delicate, right? Gee, who could have foreseen these problems?
Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.Actually, there was no need to foresee these difficulties, since they emerged in the clinical trials.
In a safety trial that enrolled 269 women ages 23 to 45, the device was successfully inserted into 200 patients. In nine of them, a coil perforated the fallopian tube, was expelled or lodged elsewhere in the body, according to a 2003 report in the journal Human Reproduction.
Trial participants were asked to keep diaries, and nearly one in 10 participants recorded painful intercourse, while one in eight had painful menstrual periods during the first three months.In a subsequent trial of 518 women, only 449 were able to rely on the device. On 21 occasions, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.
Participants again reported back pain, abdominal pain and pain with intercourse.
A citizens' petition to the FDA to w/draw the device has more than 16,000 complainants. There's a FB with 17,000 members.
The National Center for Health Research, a nonprofit group, has begun analyzing adverse event reports related to Essure, looking for patterns of complications.A study on the long term effects of the device was just published last week... and 30% of the trial participants are missing in the data.
“The fact that 16,000 women with children and a lot of things to do are willing to take the time to talk about this is very, very unusual,” said Diana Zuckerman, president of the group, referring to Mrs. Firmalino’s Facebook page. “I can’t think of another device like this.”
Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, has calculated that nearly one in 10 women with Essure would get pregnant over a 10-year period, a much higher rate than that among women who undergo tubal ligation.Not to worry, my pretties.
She finds it troubling that the long-term study published last week did not include data on 30 percent of the trial participants.
In clinical trials, she said, “the most common reason patients are lost like this is because they had a problem.”
F.D.A. officials said they were concerned about the coils moving outside the fallopian tubes, but did not believe the device was flawed.Not to pull the feminist card, but does anyone believe that a comparable device to sterilize men would last for one week after the second man reported severe pelvic pain, flu-like symptoms, and a migration of the device from his vas deferens to other internal organs?
“The agency believes the benefits outweigh the risks in appropriately selected patients who are adequately informed,” said Dr. William Maisel, deputy director for science and chief scientist in the F.D.A.’s Center for Devices and Radiological Health.
But who the hell cares? It's only women.