April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW). The purpose is to delve into how some medical devices work differently in women than men.
It’s been noted that some hip implants have an early failure rate in women and surgical mesh appears to have a high complication rate, though no one is actually tracking that at the present time.
The stated goal is to improve the:
Availability, consistency and communication of sex-specific information for the safe and effective use of medical devices in women
Addressing identified gaps and unmet needs through targeted resources
Fostering the development of innovative strategies, technology and clinical study paradigms
Much of the focus seems to be how to address research areas and talk to women being recruited for research. Meanwhile thousands of women injured by medical devices seem to have no audience with the FDA at the present time, other than entering their “adverse event” into the MAUDE database.
See how to do that here.
The workshop is being held by the division that overseas medical devices the Center for Devices and Radiological Health (CDRH) and those interested can attend in person or via webinar. Patients and patient advocates are invited to attend in person or by webcast, however a webcast does not allow access to breakout sessions. Register by June 14.
Date, Time and Location
The meeting will be held on June 24 and 25, 2013, beginning at 8:00 a.m. at the following location:
FDA White Oak Campus, Building 66
Rooms G512 and G514
10903 New Hampshire Avenue
Silver Spring, MD, 20993