Following Thousands Of Complaints From Women, FDA Puts Restrictions On Bayer’s Birth Control Implant
The FDA 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 move comes two years after the agency ordered the company to place a “black box warning” on the product package.
The New York Times:
F.D.A. Restricts Sales Of Bayer’s Essure Contraceptive Implant
The Food and Drug Administration on Monday said it would require Bayer to restrict sales of its Essure birth control implant to medical practices like doctors’ offices that agree to fully inform women about the device’s risks. Since the implant became available 16 years ago, thousands of women have sued Bayer, Essure’s manufacturer, with many claiming they suffered severe injuries, including perforation of the uterus and the fallopian tubes from the metal implant. (Kaplan, 4/9)
The Associated Press:
FDA Puts Restrictions On Birth Control Implant But No Recall
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. The new requirement comes almost two years after the FDA added its strongest warning to Essure, citing problems reported with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of the device's safety. (4/9)
The Washington Post:
FDA Restricts Sale Of Essure Contraceptive Device, Requires That Women Be Informed Of Risks
FDA Commissioner Scott Gottlieb said in a statement that the agency was making the checklist mandatory because some women were not being adequately informed of Essure's risks “despite previous efforts to alert women to the potential complications ... That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.” (McGinley, 4/9)