by Charlotte Andersen for SHAPE.com
Is Essure safe for women?Erin Brockovich, the consumer rights advocate made famous when portrayed by Julia Roberts in the movie named after her, is on a new cause, and this time it's one a little closer to her heart-well, a little lower actually: birth control.
Brockovich is taking on drug manufacturer Bayer after hearing complaints of unremitting pain, bleeding, rashes, and even loss of organs from hundreds of women about Essure, a permanent form of birth control performed by placing metal coils in the fallopian tubes, which cause scarring, thereby closing the tubes and rendering the woman infertile.
Since the FDA first approved the device in 2002, more than 700,000 women have had the coils implanted. Of those, the FDA says they've received formal complaints from slightly more than 800 women, and clinical studies showed that about 3 percent of women experienced complications with the Essure.
Brockovich says these numbers indicate a much larger problem than either the complaints or the clinical trials show, and that the device should be pulled off the market. "[Bayer] should care about the health and welfare of all people," she told ABC News. "Especially women and children in this country. If this many are reporting injuries, take it off the market. It's not working. These women were misled. They feel they were scammed."
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In an official statement, Bayer spokewoman Rosemarie Yancosek commented, "We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause. No form of birth control is without risk or should be considered appropriate for every woman." She added that more than 400 peer-reviewed studies have shown it to be safe and effective.
Renee Horowitz, M.D., ob-gyn with the Center for Sexual Wellness, says she's put in dozens of the Essure and has had no complaints. "It's my number-one choice for permanent birth control, after a vastectomy for the man." She adds that it's safer than a tubal ligation because it is less invasive, requires no general anesthesia, and has a faster recovery time.
Brockovich contends that the device is unsafe, saying, "It's a form of permanent birth control, and women's organs are being perforated. It's ridiculous that at any level we try to defend this."
Horowitz disputes Brockovich's statement. "There are some reports of migration. The coil in some cases can come out of the tube and end up in the peritoneal cavity." But unlike a tubal ligation, there's no risk of perforating blood vessels, the bladder, or the bowel with the Essure because of the way it is inserted through the cervix and uterus.
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Love it or hate it, Essure is permanent, and there is no way to remove the coil. If a woman has undergone the procedure and is experiencing pain or other issues and really wants it gone, her only option is to cut the cornua out of the uterus and the affected fallopian tube, Horowitz says.
If you're sure you're done having kids and are also ready to give up your fertility (two different issues, Horowitz says) and are considering the Essure, the thing to remember is that you're more likely to have complications with it if you have irregularly shaped uterus or tubes. So talk to your doctor and make sure that you're a good candidate first.
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by Charlotte Andersen for SHAPE.com