FDA Comments – Real World Evidence & Essure

Comments on the Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices [Docket No. FDA-2016-D-2153]   The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and do not accept financial support from insurance companies, drug … Continued

The FDA Needs to Hear From YOU!

Last month we wrote to you about the FDA’s announcement to improve the safety of the Essure System for permanent birth control. We commended the FDA for listening to the voices of women and taking action to improve patient and provider knowledge about the device. As part of their plan, the FDA released draft guidance … Continued

Essure & Challenges in Contraceptive Choice

Contraceptive needs and desires are as individual as the women who use them. All contraception should be safe and effective and not cause harm to the user; when thousands of women share stories of harm resulting from their contraception, the National Women’s Health Network (NWHN) listens. And sometimes, so does the Food and Drug Administration … Continued

Essure Update: FDA Warns Women About Risks

Earlier today, the FDA announced that it is taking steps to make it easier for women considering sterilization to get reliable information about Essure, an implanted device.  The Network recommended that the FDA take these steps, and we’re pleased that they’re taking action on this important women’s health issue. Essure is a permanently implanted birth … Continued

“FDA’s Actions on Essure are Steps in the Right Direction” NWHN statement in response to FDA Draft Guidance

FOR IMMEDIATE RELEASE Contact: Cindy Pearson at cpearson@nwhn.org or 202.682.2640, ext. 0 Safe & effective contraception, including permanent contraception, is an essential component of women’s health and economic security.  Women rely on the FDA to make sure that the risks of contraceptive methods are low, and well understood.  Today, the FDA took important first steps to … Continued

FDA Meeting – Essure

Testimony Delivered at the Meeting of the FDA Meeting of the Obstetrics and Gynecology Devices Panel September 24, 2015 My name is Cindy Pearson, and I am the Executive Director of The National Women’s Health Network. The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. … Continued

NWHN in Action – May/June 2015

Raising Women’s Voices for the Health Care We Need On March 4th, Network staff braved the cold and rain to rally in front of the U.S. Supreme Court and voice their support for health insurance subsidies. That was the day the Court heard oral arguments in King v. Burwell, a critically important threat to the … Continued