Transvaginal Mesh Update
On July 13, 2011 the Food and Drug Administration released a safety communication warning to physicians and health care professionals, as well as patients, that the placement of surgical mesh through the vagina to treat pelvic organ prolapse may pose a greater risk for the individual than other options.
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So far, the FDA has received more than 1,000 reports concerning complications connected with the transvaginal mesh. The FDA also reported that the mesh can become exposed or protrude out of the vaginal tissue, cause severe pain, infection, organ perforation, and urinary problems.
There are several cases that required additional surgery or hospitalization for treatment or to removal of the mesh.
In 2010, manufacturers estimate more than 75,000 women had TVM surgery to repair pelvic organ prolapse.
The latest research shows that roughly ten percent of women who have received TVM implants experience mesh erosion within 12 months of surgery and more than half of these patients need further surgery to remove the mesh following complications.
The FDA reported the most common side effect is a potentially serious and painful complication involving the mesh that can cause the skin to split.
Other side effects are infection, or recurrence of pelvic organ prolapse or stress urinary incontinence, all of which are medical issues TVM implants are supposed to fix.
The potentially severe side effects became evident in 2009 when a clinical trial was stopped after 15 % of the women implanted with the mesh suffered vaginal mesh erosion within a stage of only three months.
If you had a transvaginal mesh implant and now experience harmful side effects, you are not alone.
During the past three years, the FDA has received more than 1,000 reports of severe complications in connection with the implants.
On July 13, 2011 the FDA released an urgent updated advisory recommending patients and doctors think about alternatives to transvaginal mesh (TVM).
By: South Carolina Personal Injury Lawyer Pete Strom