WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology

Oct 4th, 2011 | By | Category: FDA

Dr. Thommaso Falcone, Cleveland Clinic

Synthetic surgical mesh has been on the hot seat of late after a July 13 FDA Safety Communication said that complications are “not rare,” a reversal from an October 2008 Public Health Notification which downplayed side effects as “rare”occurrences.

The latest notice says additional surgeries may be needed to address mesh-related complications such as vaginal mesh erosion, also known as extrusion or protrusion, perforation, neuro-muscular problems, recurrent prolapse, vaginal scarring and shrinkage.The review showed that “transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.”

The FDA found between January 2008 and December 2010 there were 2,874 complication reports to the agency including injury, malfunctions and death.

Reports to the FDA’s complicated and difficult to find database are thought to represent a small percentage of actual events.

 

EXPERT PANEL GATHERED

On September 8 & 9, an expert panel was made up of seven medical doctors in the area of obstetrics and gynecology gathered in Gaithersburg, Maryland to make recommendations to the Food and Drug Administration about the future of synthetic surgical mesh. Day One was spent looking at the adverse events of mesh for pelvic organ prolapse (POP) and Day Two for stress urinary incontinence (SUI).

Their decision expected sometime soon will determine the future of mesh. If it is reclassified to Class III or high-risk, synthetic surgical mesh made of a plastic-like material, may not pass the rigors of clinical trials required of that designation.

*Note some of the panelists have received funding from the nine major mesh manufacturers among them Johnson & Johnson (Ethicon), Bard, American Medical Systems and Boston Scientific.

 

These are the Men and Women who Made Up the Panel of Experts:

*Consumer Representative

**Industry Representative

Chairperson Thommaso Falcone, M.D.
Expertise: Obstetrics and Gynecology,
Professor and Chairman Dept. of Obstetrics & Gynecology,
Cleveland Clinic Foundation

Here is his CV

Designated Federal Official
Shanika Craig
Center for Devices and Radiological Health
Office of Device Evaluation

Andrew I. Brill, M.D.
Expertise: Obstetrics and Gynecology,
Dir., Minimally Invasive Gynecology Reparative Pelvic Surgery & Training
California Pacific Medical Center

Here is his CV

Paula J. Hillard, M.D.
Expertise: Obstetrics and Gynecology,
Professor and Chief Gynecologic Specialties
Stanford Univ. School of Medicine

Here is her CV

Ann J. Davis, M.D.
Expertise: Obstetrics and Gynecology
Professor Dartmouth Medical School

Here is her CV

Lisa M. Maldonado, MPH*Expertise: Reproductive Health Care
Executive Director Reproductive Health Access Project, NYC

Here is her CV

** Sergio J. Gadaleta, Ph.D.,
Expertise: Regulatory Affairs
Vice President, Regulatory Affairs, Becton Dickinson
Here is his CV

Frank W. Ling, M.D.
Expertise: Obstetrics and Gynecology,
Obstetrician Women’s Health Specialists,
Germantown, TN

Here is his CV

Russell R. Snyder, M.D.
Expertise: Obstetrics and Gynecology,
Associate Professor, Dept. of Ob/Gyn
Univ. of Texas Medical Branch, Galveston, TX 

Here is his CV

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2 Comments to “WHO ATTENDED: September 8-9 FDA Public/ Expert Meeting on Medical Devices for Obstetrics and Gynecology”

  1. Amy Gezon says:

    Wow I am certain Dr. Flacone isn’t biased after receiving a $1,000,000 grant from ethicon in developing minimally invasive devices. What corruption! It’s great to know that the chairperson of the independent advisory is in receipt of significant money for Cleveland Clinic from an industry that he is supposed to evaluate the safety data from.

  2. Amy Gezon says:

    How can Galdetta, go from working for the FDA to working for Ethicon, a leading manufacturer of transvaginal mesh kits, to Becton Dickson then return as an “independent” advisory panel member on the safety of transvaginal mesh….perhaps there is a connection with his disconnect of the lack of safety outcome measures with these products. This is so wrong for so many reasons.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.