Essure Birth Control Procedure Tied to Mounting Injury ReportsOct 17, 2013
Permanent birth control method Essure has allegedly led to serious adverse reactions and has caught the attention of well-known consumer advocate Erin Brockovich.
Brockovich, who is seeking to have Essure banned, told ABCNews.com that last year she’d heard about women suffering significant adverse reactions tied to the sterilization procedure. "There's something wrong with the device, in my opinion," Brockovich said. "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. If 30 women did suffer harm for unknown reason, we'd investigate. We have thousands injured. I don't think it's safe."
According to the Mayo Clinic, the Essure system is a permanent birth control method for women composed of two small metal and fiber coils placed in the fallopian tubes through the vagina. No incision is needed. Scar tissue forms around the coils, which blocks the fallopian tubes and stops sperm from reaching the egg. Another form of birth control must be used for a few months after Essure is inserted. The procedure is followed up with an hysterosalpingography X-ray to confirm that the fallopian tubes are blocked. The procedure, noted the Mayo Clinic, does not protect against sexually transmitted diseases, is not reversible, and does not impact menstruation.
The Essure procedure received U.S. Food and Drug Administration (FDA) approval in 2002 and is marketed by Bayer. "[Bayer] should care about the health and welfare of all people," Brockovich told ABCNews.com. "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." Conceptus, the original designer and maker of Essure, indicated that more than 700,000 women have undergone the procedure. FDA adverse event reports indicate that, to date, more than 800 women have filed reports with the agency since 2004, ABCNews.com reported.
One woman told ABCNews.com that she opted for Essure based on the manufacturer’s claims of minimal downtime. She suffered from severe cramping and was having difficulty moving. When she complained to a physician, he put an Essure coil in her face and told her that something so small would not cause that type of pain, she told ABCNews.com. She underwent a hysterectomy after learning that a so-called “misshape” in her fallopian tube caused the coil to eject into her uterine wall.
Dr. Jennifer Ashton, senior health contributor for ABC News, was trained in the Essure procedure in 2002 and says she chooses not to perform it on her patients, opting, instead, for other forms of permanent birth control with a better risk-benefit profile. "Whenever there is the permanent placement of a foreign body—in this case, metal coils—inside the body, there is the potential for chronic pain," Ashton said. "Because Essure does not offer any known benefit towards risk reduction of ovarian cancer, as a tubal ligation does, I feel that other forms of permanent birth control are better and safer, including male vasectomy. Women considering permanent birth control should be offered all options, including tubal ligation and male vasectomy, not only the procedure that a woman's doctor is able to perform personally," she noted.
The Mayo Clinic website indicates that risks associated with the Essure procedure include infection, pelvic pain, perforation of the uterus or fallopian tubes, and tubal blockage occurring on only one side. There are some patients that make poor candidates and some procedures cannot be performed following implantation, such as some pelvic electrosurgical procedures, because of the Essure inserts’ metallic components.