Federal health regulators plan to warn consumers more strongly about Essure, a permanent birth-control implant. The contraceptive implant should come with stronger warning labels on potential health risks, the Food and Drug Administration said.
The announcement follows after the regulation agency received more than 5,000 reports of complications linked to the use of the device. It also announced an obligatory clinical study of the device including requiring changes to warning labels. This will help women who want to use the device to fully understand the possible health risks of using it.
"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said FDA's Dr. William Maisel.
"They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications," he added.
What Is Essure?
Essure is a non-surgical permanent birth control option for women who do not wish to get pregnant again. The device is manufactured by Bayer.
It works by inserting flexible coils into the vagina, through the cervix, then into the fallopian tubes. In about three months, scar tissue forms that would create a barrier from the egg cells and sperm cells, preventing fertilization.
Since 2002, about 750,000 women have received Essure. If the device is correctly inserted, it is about 99 percent effective in preventing pregnancy.
The insertion will take about 10 minutes and most women can go home 45 minutes after the procedure. They can immediately return to normal activities within two days.
Another benefit of the device is that it is non-hormonal, which means that it cannot lead to complications linked to the use of some birth control methods, like oral contraceptive pills.
Essure Issues And Serious Health Complications
The FDA said that some women experienced complications like continuous pain, perforation of the fallopian tubes or uterus, abnormal bleeding and hypersensitivity reactions.
Advocating Safety in Healthcare E-Sisters (ASHES), a non-profit organization, put up Essure Problems, a website that warns users of serious complications associated with the use of Essure. They released relevant data on health risks brought about by the insertion of this permanent birth control device.
According to the report (PDF), a total of 4,258 women underwent removal or other surgeries linked to complications of Essure. This is just a portion of the women who had Essure removal surgeries based on data the organization collected in the past two years. The majority of these (2,604) were total or partial hysterectomy including devices and tubes - a surgery involving removing a woman's uterus.
"Frankly, I'd contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It's been done," Rep. Mike Fitzpatrick, R-Pa. said.
"The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths. As my constituent, Dr. Amy Reed, a victim of unsafe devices herself, testified at the FDA in September, '[w]e don't need to hurt any more women.' If the FDA is going to order another study, then at minimum they should take Essure off the market during that time. A 60 day comment period and another study while this device remains on that market only guarantees more women harmed," he added.
New Clinical Studies And Warning Labels
The FDA ordered Essure's manufacturer to perform new clinical studies designed to give important information on potential risks of the device. This postmarket study is geared to shed light on what really happens to women using the device.
The clinical studies will evaluate complications linked to the use of the device and compare them to traditional methods like ligation.
Aside from clinical studies, FDA calls for new warning labels on the product that will describe serious health problems linked to the device.
FDA will also require a checklist for physicians to use in discussing the risks of the device to inform women of possible effects.
The checklist will not only help in the patient's decision making, but also highlights the importance of undergoing confirmation tests three months after the procedure. The test post-implantation will allow doctors to check if Essure is properly inserted and can really prevent pregnancy.
