Transvaginal Mesh Recall, Requested by Public Citizen

Public advocacy group, Public Citizen, has just petitioned the FDA to ban all surgical mesh products for use in transvaginal repair procedures and for the manufactures to recall their products on the market today.   Public Citizen claims that these mesh devices expose patients to unnecessary risk without providing benefits above and beyond safer alternatives.

Public Citizen claims that about 75,000 women had prolapse surgery last year that involved some form of mesh implant.  Public Citizen's Dr. Michael Carome is quoted as saying,"Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."

This is true.  Last month, the FDA made harsh statements against these products and advised against using them.  Deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, Dr. William Maisel, "There are clear risks associated with the transvaginal placement of mesh to treat POP." 

The timing of this recall request is notable, as advisory panel members of the FDA plan to meet on September 8th to further discuss the efficacy and safety of such mesh devices. 

Mesh erosion is the most commonly reported problem associated with transvaginally implanted mesh devices and can cause considerable pain and discomfort as well as bleeding and infection.