Consumer Reports on Thursday weighed in on the controversy over Essure permanent sterilization coils, advising women considering the device to ask their doctors about possible complications and what happens if removal becomes necessary.
In an online article, the nonprofit product-rating group explains that Bayer Healthcare's Essure was hailed as a godsend when it was approved 15 years ago because it is the only non-surgical form of sterilization. The article says about 500,000 women, most in the U.S., have had Essure's two small metal coils inserted in their fallopian tubes to scar the tubes shut.
But over the past several years, about 17,000 women have reported serious complications to the U.S. Food and Drug Administration, including organ perforations, broken coils, pain, miscarriages, fetal deaths, and mysterious allergies that may be related to nickel in the device. Roughly half of the women reporting problems wound up needing surgery — in many cases, hysterectomy, Consumer Reports notes.
A drumbeat of other media reports have delved into the Essure controversy. The Inquirer recently described the advocacy efforts of a 37,000-member Facebook group called Essure Problems, which wants the FDA to take the device off the market. The Washington Post last month wrote about "the battle over Essure," noting that usage seems to be falling; sales of Essure among about 2,000 doctors who implant it dropped by 70 percent since 2010.
The FDA has taken several steps to address Essure safety concerns, including ordering Bayer to add prominent label warnings and conduct a new study to evaluate risks. The manufacturer also created a patient safety checklist, although doctors aren't required to use it.
"Despite these measures — or perhaps because of them — the picture for consumers is now muddier than ever," the article says. "Even with a list of risks that includes punctured organs, ectopic pregnancies, and severe allergic reactions, the FDA and the American College of Obstetricians and Gynecologists have said that Essure is a safe option for women seeking to permanently prevent pregnancy."
Consumer Reports recommends women ask their doctors about four issues before getting the implant:
The risks. Women should go over Bayer's safety checklist, and be aware that experts believe a history of problems such as endometriosis or chronic pain may increase the risks. Women should also get tested for nickel allergies.
The doctor's experience. Ask how many implants the physician has done, and rates of failed implants and complications.
Removal. If complications arise, will the doctor remove the coils? "There is no hands-on training for removal surgery nor any consensus about the best or safest way to extract the coils," the article cautions.