Surgeon Allegedly Fails to Disclose Association With Vaginal Mesh Manufacturer

This case takes place in New Hampshire and involves a lack of informed consent and complications as pertains to a transvaginal mesh device. The female patient in this case had a transvaginal mesh device placed. The device was removed less than a month later by the same the physician who originally implanted it, in order to alleviate chronic inflammation, fibrosis, UTI and severe abdominal and vaginal pain that the patient experienced as a result of the device.

The plaintiff alleges that the gynecologist who performed the surgery served as a spokesperson for the company that produced the transvaginal mesh product that she received, and that the implanting surgeon was paid for using that specific delivery system. In addition, the surgeon was seen by the rest of the medical community as a key opinion leader who consults with and trains other surgeons, through which she encourages them to use the company’s product. The plaintiff’s basis of contention is that the gynecologist did not inform her that the surgeon planned on using the very same product she had been paid to promote during the process of obtaining informed consent.

Questions to the OBGYN expert and their responses

Can you discuss your background/expertise in performing these type of procedures?

I have a significant background/expertise in performing, teaching and removing mesh kits of various types. I was an instructor for US Surgical/Tyco for some length of time in placing their mesh product. I have published on the subject, been deposed, and have been used as a resource by a large group of attorneys in Atlanta on the topic. I have personally placed a fair number of kits and still occasionally do so.

Can you describe your informed consent process?

The Division of Female Pelvic Medicine and Reconstructive Surgery at the university where I work has designed pre-printed consent forms for as many individual surgical procedures as possible, including those involving mesh. If a physician is receiving financial compensation for the actual use of any surgical procedure or kit, in my opinion, a conflict of interest exists and the surgeon should make the patient aware at some point.

About the expert

This highly qualified and board-certified expert currently serves as Associate Professor and Division Chief in the Department of Obstetrics, Gynecology, and Women's Health at a major medical university. He received a B.S. in Biology from Morehouse College and a M.D. from Case Western Reserve University School of Medicine. He finished a fellowship in Gynecology, Urogynecology, and Pelvic Reconstructive Surgery at the Mayo Clinic in Scottsdale. Elected as a Junior Fellow to the American Congress of Obstetricians and Gynecologists, he has been elected one of the Best Doctors in America. He activelrves in editorial roles for scientific journals including the Journal of Reproductive Medicine and the International Urogynecology Journal. He previously was the Director of the Georgia Center for Pelvic Health at the HCA Doctors Hospital and Associate Professor of Urogynecology and Pelvic Surgery at the Medical College of Georgia.

E-008171

Specialties:

OBGYN