Essure birth control device is linked to unplanned pregnancy, hysterectomy, and other serious side effects.
The FDA just took a big step to limit the use of a permanent birth control device that's been the subject of thousands of lawsuits
(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG's implanted birth control device Essure, two years after the agency put a severe warning label on the product.
The FDA said here some women were not being properly informed of the risks associated with Essure before getting implanted.
The FDA's restrictions will limit the sale of Essure only to healthcare facilities that provide full information about the device's risks and benefits, the agency added.
READ MORE: Business Insider
FDA puts restrictions on birth control implant but no recall
U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market.
The Food and Drug Administration said only women who read and have the opportunity to sign a brochure about the risks of the device will be able to receive the implant made by Bayer. The checklist of risks must also be signed by the woman’s doctor.
READ MORE: Stat News/Associated Press
What Women Should Know About Essure Permanent Birth Control
The U.S. Food and Drug Administration continues to advise women to carefully consider the benefits and risks associated with permanent birth control devices, like the FDA-approved Essure device, along with other birth control options.
That’s why FDA recently approved important labeling changes for Essure. Among other changes, Bayer, the company that makes Essure, will include a boxed warning and patient decision checklist in the labeling to help ensure that women receive and understand the benefits and risks of these permanent birth control devices.
READ MORE: FDA Notice
Erin Brockovich Leads Fight Against Birth Control Procedure Essure
A popular and permanent form of birth control that hundreds of women say is causing severe adverse reactions has now become the latest cause of famed consumer advocate Erin Brockovich, who has launched a grassroots campaign against the procedure.
Brockovich, who in 1993 led a multimillion-dollar groundwater contamination case against Pacific Gas and Electric Co., has launched a campaign to have the Essure procedure taken off the market of birth control options. Brockovich told ABCNews.com that she first heard of the product about a year ago, and after hearing an increasing number of horror stories launched the campaign and online petition for women to share their stories about Essure, inform each other and initiate change.
READ MORE: ABCNews.go.com
FDA mandates new warnings, new data for Essure contraceptive device
(CNN)The U.S. Food and Drug Administration said it will require a new "black box warning" label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is "designed to call attention to serious or life-threatening risks," according to the FDA website.
Monday's announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.
READ MORE: CNN.com
Essure birth control controversy: 5 things you should know
A permanent birth-control implant called Essure will need to be labeled with a stronger warning that lists potentially serious risks of the device, the Food and Drug Administration announced this week.
The action comes after the FDA received more than 5,000 reports of complications from the device, including chronic pain, bleeding and allergic reactions, since the device was approved in 2002.
READ MORE: FoxNews.com
Did The FDA's Actions On The Essure Contraceptive Go Far Enough?
Five months after convening an advisory committee meeting to discuss concerns about the safety of Essure, the only non-surgical permanent contraceptive, the Food and Drug Administration on Monday announced new measures "to help women and their doctors be better informed" of potential complications linked to the device.
The FDA said it is going to require a "black box" warning--the strongest type of warning--on the device's labeling and a "Patient Decision Checklist to help ensure women receive and understand information regarding the benefits and risks of this type of device." In addition, the agency has ordered Bayer , the manufacturer, to conduct a new study to collect information about Essure's risks in a "real-world" environment.
READ MORE: Forbes.com