FDA Warning on Transvaginal Mesh Sparks Call for TVM Marketing Changes

Oklahoma City, OKThe US Food and Drug Administration (FDA) issued a warning on urogynecologic surgical mesh implants in July, which included the Avaulta mesh implant. The mesh implants have reportedly caused severe pain and complications in the women that used it.

According to a report at KOCO.com, a group of women from Oklahoma had been administered mesh implants to help fix problems they began to experience after childbirth. These included urinary incontinence and pelvic organ prolapse (POP) or the the displacement of pelvic organs.

The women were given the mesh implants to relieve some of the symptoms of their painful conditions, but instead of alleviating their discomfort, the transvaginal mesh (TVM) implants allegedly caused their conditions to worsen.

The women--five in total--are now fighting for a change in the way that mesh implants are advertised to the public. Their battle began soon after the FDA issued its warning concerning the mesh implants and the potential for TVM patients to develop severe pain, according to the news source.

Linda Hunt, Barrie Porter, Joyce Wese, Lynda Barrett and Ilona Begley say that they are now forced to live with deep physical and emotional pain due to having been treated with a surgical mesh implant.

Hunt told KOCO.com that her life since the use of the mesh implant has been "very depressing" and Porter noted "it kind of ruins your life."

Each of the five women from Oklahoma got a mesh implant to support their pelvic wall. Instead of providing relief for the individuals, the product caused excruciating pain and a general discomfort turned into much worse.

Wese told KOCO.com, "It’s like labor pains, but constant."

Barrett also explained that her pain was beyond understanding. "Nobody has any idea. You cannot explain to anybody what mesh is like."

The FDA reported as part of its warning that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare". The FDA warning followed more than 2,800 women reporting problems with the mesh implants.

Dr. Lieschen Quiroz, a women's pelvic and bladder health specialist, noted that the FDA warning was just the beginning.

"What the FDA is reporting is the tip of the iceberg as far as complications are concerned," she told KOCO.com.

According to the FDA, there is a possibility that serious complications associated with surgical mesh for transvaginal repair could arise, and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.