Is Surgical Mesh The Only Option Left? - Searcy Denney

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Brenda Fulmer

Informed Decisions and the Use of Surgical Mesh

» Written by // August 4, 2011 //

Late last month, the FDA announced an additional safety warning for the use of vaginal mesh to repair pelvic organ prolapse.  The July 13th warning urged surgeons to consider all other treatment options before deciding to use surgical mesh.  The agency stated that in most cases, pelvic organ prolapse could “be treated successfully without mesh.”

Women have the vaginal mesh permanently implanted in order to fix a common gynecologic problem, pelvic organ prolapse.  Pelvic organ prolapse occurs when vaginal support is lost, resulting in the dropping of the bladder, urethra, cervix, and rectum.  The American Urogynecologic Society estimates that approximately 50% of all women between the ages of 50 and 79 have some form of prolapse.  Complications from implantation of the mesh include pain during intercourse, infection, bleeding, perforations of the bowel or bladder, and the protrusion of the mesh through the vaginal wall.

Some surgeons fear that this warning will make patients unnecessarily wary of opting for the mesh.  They are also concerned that surgeons will stop performing the procedure altogether.  According to Halina Zyczynski, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at Magee-Womens Hospital of the University of Pittsburgh Medical Center, said that the “vast majority” of women do not experience complications from the mesh.  However, she is happy that the FDA is keeping the public informed.  Media reports indicate that there were 100,000 surgeries performed in 2010 for pelvic organ prolapse which utilized mesh products, and that about 75% of these procedures involved the placement of mesh through the vagina.  On the other hand, other physicians don’t believe that the procedure should be performed at all. “We don’t do them.  No one at the Mayo Clinic feels there is added benefit,” said Dr. Daniel Elliot, an assistant professor of urology at the clinic in Rochester, Minn.

The recent FDA alert as well as the initial FDA notice in October of 2008 have helped to alert many patients to these device-related safety concerns, but for many the notice came too late.  Issues relating to this class of devices are not new.   More than a decade ago, there was coordinated litigation in multi-district litigation (MDL) proceedings in Baltimore over the ProteGen Sling and Vesica System products, which were manufactured and marketed by Boston Scientific.   Several years later, a number of lawsuits were filed and coordinated through the federal court in Atlanta over the Mentor ObTape, a product that was withdrawn from the market in March of 2006 following a number of reports of serious safety issues.  Within the past several months, safety concerns and litigation over transvaginal mesh and slings has expanded dramatically to involve a number of different products:

Manufacturer Products
Johnson & Johnson Ethicon TVT
Johnson & Johnson Gynecare TVT
Johnson & Johnson Gynecare Prosima
Johnson & Johnson Gynecare Prolift
Johnson & Johnson Gynemesh PS
Boston Scientific Advantage Sling System
Boston Scientific Obtryx Curved Single
Boston Scientific Obtryx Mesh Sling
Boston Scientific Prefyx Mid U Mesh Sling System
Boston Scientific Prefyx PPS System
Boston Scientific Arise
Boston Scientific Pinnacle
Boston Scientific Lynx
Boston Scientific Solyx
C. R. Bard Avaulta Plus BioSynthetic Support
C. R. Bard Avaulta Solo Synthetic Support
C. R. Bard Faslata Allograft
C. R. Bard Pelvicol Tissue
C. R. Bard PelviSoft Biomesh
C. R. Bard Pelvitex Polypropylene Mesh
American Medical Systems SPARC
American Medical Systems BioArc
American Medical Systems MiniArc
American Medical Systems Elevate
American Medical Systems Monarc
American Medical Systems Perigree
American Medical Systems In-Fast
American Medical Systems Apogee

Hopefully, women contemplating the surgical implantation of vaginal mesh in the future will be able to make informed decisions about their options now that the Food & Drug Administration and healthcare providers are finally asking critical questions about the safety and efficacy of these devices.  Unfortunately, this public dissemination of information comes too late for the tens of thousands of women who have been implanted with these devices and are now facing catastrophic health issue stemming from the ineffective and defective medical devices.

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