Pelvic Organ Prolapse Mesh -or- “POP”

A recall of Gynecare Prolift Kit, Gynecare Prolift +M Kit, Gynecare Prosima Kit, and Gynecare TVT Secure from Ethicon (a subsidiary of Johnson & Johnson) occured on June 4th 2012. This recall is the first movement by any pelvic mesh manufacturer to withdraw a group of pelvic mesh products from the market.

Johnson & Johnson said it would “stop selling Prolift Vaginal Mesh implants after a raft of lawsuits about the devices causing complications such as infections and bleeding.” By doing this J&J has asked the FDA to stop the various 522 orders issued by the FDA requiring additional studies. Furthermore, Ethicon announced that it would no longer produce the POP device and asked that it be allowed 120 days for full cessation. Ethicon also announced that it would restrict the indication of its Gynemesh product to use in abdominal sacrocolpopexy repair.

The Prolift and Prosima consist of synthetic woven polypropylene mesh that is marketed to OBGYN’s and gynecological surgeons as a solution to “Pop” (Pelvic Organ Prolapse) repair. It has become common place for women to receive mesh implants instead of undergoing more traditional procedures. The “Colporrhapy” procedure and the “Abdominal Sacrocolpopexy” procedure are natural, traditional procedures that are not being used as often as “POP” repair. An estimated 75,000 women receive mesh implant repair per year.

The FDA posted an update on serious complications associated with Transvaginal placement of surgical mesh for pelvic organ prolapse.

The literature review revealed that:

Mesh used in transvaginal POP repair intruduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.