Free Case Evaluation
Connect
With Us

FDA Workshop on Health of Women

Woman statue resizedApril 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

 

2 Comments

  1. mmm says:

    I am not sure how many women who are affected by this mesh will be able to travel to this workshop. I registered to view the webcast. Thank you for posting this information Jane!

  2. P J says:

    i CALLED THE FDA THE OTHER DAY TWICE TO TALK ABOUT THE MESH, AND WAS HUNG UP ON, ONE i AM NOT SURE IF HE OR SHE WAS A AMN OR WOMAN, BUT 1 WAS A WOMAN. TYHE FDA hangs the phone up on women like me that want to ask questions about the mesh and why did they allow the mesh to be used in women without testing,

    THEY HAD PEOPLE EVEN A FEW YEARS AGO, WHEN i CALLED ABOUT A MEDICINE i was given by the doctors that even put my mesh in , that almost took me out of thos world about 4 years ago, 4 days and 4 nights , I RAN HIGH FEVER , CHILLS, MY HEART RACING LIKE IT WAS COMING OUT OF MY BODY. AND PEOPLE ANSWERING THE PHONES FOR FDA KEPT HANGING THE PHONE UP ON ME, WORK SHOP FROM FDA BEING A GUINEA PIG AGAIN FOR MEDICAL RESEARCH IN ALL STATES …. HELL NO!

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This is a Sundown Legal Marketing law firm website.