Four mesh products have been recalled that belong to the Gynecare family of polypropylene mesh under the Ethicon division of Johnson & Johnson.
In a June 4th letter Ethicon advised the court it was suspending the sale of synthetic vaginal meshes and on page 2 there is a curious note indicating that Ethicon had decided to leave the Gynecare Gynemesh PS product on the market but would be changing its labeling. The company says it will recommend the mesh be implanted during an “abdominal sacrocolpopexy procedure for the treatment of pelvic organ prolapse.” That means the surgeon connects the vagina to the bone at the base of the spine to hold up a prolapsing vaginal vault.
The company requests that it be allowed to continue “the sale of GYNECARE GYNEMESH PS using the current Instructions for Use until FDA responds to this proposed plan.”
In other words – business as usual with the Gynemesh.
Synthetic mesh made of polypropylene is linked to infections among other complications such as mesh eroding or moving in the body, perforating organs, curling into a ball and causing infections that often require multiple surgeries to stabilize the patient.
Interesting then that the company is requesting it will use the mesh only for abdominal surgery placement.
During the September 2011 hearings before an expert committee of the FDA gathered to discuss the mesh mess, Dr. M. Tom Margolis addressed this very issue. He told the group he does not place mesh transvaginally, or through the vagina, because of the risk of infection. The problem for surgeons is always contamination.
There are four states of cleanliness in terms of surgical fielding:
- clean/ clean; clean/contaminated
- grossly contaminated
Vaginal surgery by definition is clean/contaminated. It is a cardinal surgical rule, Dr. Margolis said, that you not place an implant, especially a synthetic material through any form of contaminated field without significant risk of mesh infection or mesh breakdown and eventually failure. He told the group he had done close to 1,000 laparoscopic procedures with synthetic mesh and had had perhaps two infections.
Last July, the FDA told manufacturers that “mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.”
Unfortunately, since that time about 75,000 women have received the transvaginally placed mesh.
Perhaps the fear of 700 lawsuits naming Ethicon in a New Jersey state court and 400 in Federal Court so far, with the number growing finally forcing Ethicon to take a small step toward patient safety.