Essure, a permanent birth control method marketed by Bayer, has been tied to allegations of serious adverse reactions, according to well-known consumer advocate, Erin Brockovich.
Brockovich is working to have the Essure banned and told ABCNews.com that, about one year ago, she began hearing about women reporting serious adverse reactions associated with 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,” she added, according to ABCNews.com.
The Mayo Clinic indicates that the Essure system is a permanent method of birth control for women that is comprised of two small metal and fiber coils that, by vaginal insertion, are placed in the fallopian tubes; no incision is required. Scar tissue is meant to form around the Essure coils, blocking the fallopian tubes and stopping sperm from reaching the egg. In the first few months, a different form of birth control is needed. The Essure procedure must be followed up with an hysterosalpingography X-ray to confirm blockage of the fallopian tubes. The non-reversible procedure does not protect against sexually transmitted diseases and does not impact menstruation, noted the Mayo Clinic.
The U.S. Food and Drug Administration (FDA) approved the Essure procedure in 2002. “[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.” According to the original designer and maker of Essure, Conceptus, more than 700,000 women have undergone the procedure. More than 800 women have filed adverse event reports with the FDA since 2004, ABCNews.com reported.
In one case, a woman told ABCNews.com that she underwent the Essure procedure, mostly because of manufacture claims of minimal downtime. The woman said she soon suffered from severe cramping and was having great difficulty moving. She complained to a physician who, in response, flashed an Essure coil in her face and said that something so small would never lead to that type of pain, she told ABCNews.com. She underwent a hysterectomy and was told that a so-called “misshape” in her fallopian tube led to the coil ejecting into her uterine wall.
Dr. Jennifer Ashton, senior health contributor for ABC News and who underwent Essure procedure training in 2002, says she does not to perform the procedure on her patients. Instead, she said, she utilizes other forms of permanent birth control with improved risk-benefit profiles. “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 added.
The Mayo Clinic website indicates that Essure procedure risks include infection, pelvic pain, perforation of the uterus or fallopian tubes, and tubal blockage occurring on only one side. Some patients make poor candidates and some procedures cannot be performed following the Essure procedure, including some pelvic electrosurgical procedures, due to the Essure inserts’ metallic components.