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. (Perrone, 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)
The Hill:
FDA Restricts Sale Of Essure Birth Control After Thousands Of Complaints
“We take the concerns of all women affected by Essure very seriously," FDA Commissioner Scott Gottlieb said in a statement Monday. "I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.” Patient advocacy groups and lawmakers have called for the FDA to remove the device from the market. (Hellmann, 4/9)
The Wall Street Journal:
FDA Adds Restrictions On Sale Of Bayer’s Essure
Women who had testified before a panel of independent medical advisers described fatigue, hair loss and depression, as well as persistent pelvic or abdominal pain after taking Essure. There were also reports of rash, hives, nausea, swelling and increased symptoms of asthma and arthritis that women attributed to the implant. Since adding the warnings in 2016, the FDA said sales of Essure have declined roughly 70% in the U.S. Essure gained FDA approval for sale in 2002. (Moise, 4/9)
Meanwhile, in other news from the agency —
Stat:
Here’s What’s In The FDA Plan To Include Pregnant Women In Clinical Trials
The FDA has taken a big step in encouraging drug companies to include pregnant women in clinical trials, issuing a draft guidance outlining how to do so safely and ethically. Nearly 4 million women in the U.S. give birth each year, but few drugs have been approved as safe and effective to use during pregnancy. The new guidance aims to help drug companies address those information gaps “through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.” (Thielking, 4/10)
Kaiser Health News:
C-SPAN: FDA Commissioner Scott Gottlieb Talks To KHN
Kaiser Health News reporter Sarah Jane Tribble sat down with Dr. Scott Gottlieb, commissioner of the Food and Drug Administration, on C-SPAN’s “Newsmakers” program, which aired Sunday. Tribble was joined by Bloomberg correspondent Anna Edney. The conversation ranged from how the nation should combat the opioid epidemic to reining in drug prices. Gottlieb said competition in the drug market remains key to lowering prices. (4/9)
USA Today:
FDA's Scott Gottlieb Pushes For More Food Safety To Improve Health
The Trump administration’s top food and drug regulator is pushing for less salt in food, more nutrition information on labels and innovative ways to communicate healthy ways of eating, all of which Scott Gottlieb says could make more of a difference than anything else his agency could do, short of curing cancer. Gottlieb, the Food and Drug Administration commissioner, has positively surprised critics of the administration’s regulatory agenda elsewhere. (O'Donnell and Parker, 4/6)
