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

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

3 Comments

  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.

  3. Charity says:

    Dr. Ling in Germantown, TN (Memphis area) works at the same practice (“Women’s Health Specialists”) as doctors Vogt and Stovall. I asked you about them earlier because they were on your list.

    The link doesn’t work for me. Is Ling in support of implants? If so, that’s not promising for help for mesh victims from the other two doctors. I’ve been digging around about them. I’ve read conflicting reviews about Vogt (female), some really good and some really bad. I’ve read mostly horrible reviews about Stovall (male). (Like I dont even want to get into those on here they’re so bad!) Their practice overall sounds kind of crummy. I just messaged their website specifically asking them about a complete Monarc TOT removal. I also asked them if they knew of anyone in the tri-state area (Tennessee, Arkansas and Mississippi) who can do ex-plants just in case they don’t. I will message you what I find out when they reply back.

    I don’t like fighting my insurance for the travel reimbursement they promise when filing a legitimate claim. Tricare approved and paid for my surgery. Now suddenly they’re convinced that a surgeon is closer to me after all. I’m pretty certain Veronikis is the closest one and I’m glad he did it!

    I sent those jackals an email today and I let them know that I’ve done all that they asked of me and then some. I told them that the burden of proof is now on them. They need to provide me with the names, emails and addresses, etc of the surgeons in Memphis that they are now saying could have done my ex-plant this past September. If not, they need to pay up for if they don’t, they’ll regret it. I have a long history of MAJOR military medical malfunctions as a dependent that I am still suffering from every day. I Will actually do something about it all if they don’t change their tune.

    I also want to set the record straight with Tricare. I don’t want them to send unsuspecting women to those butchers who only do partials or add more mesh to their implants. If there’s anyone who can help my insurance company see the light it’s me. I’ll gladly strike a match!

    Happy Thanksgiving, everyone! Just know you’re not alone. You are loved and I hear you.

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