Vaginal Mesh: Potential disasters

The publication, on 13 July 2011, by the Food and Drug Administration (FDA) of a safety alert, concerning “serious concerns” relating to the potential complications of a surgical device, commonly known as transvaginal mesh, is alarming.

For the past 15 years Vaginal mesh has been routinely used in approximately 25% of case where surgery has been employed to correct a Pelvic Organ Prolapse (POP).

There are many reasons for a POP and contributing factors include childbirth, hysterectomy, obesity or complications resulting from pathology like pelvic tumors or even a persistent cough or chronic constipation. This commonly gives rise to symptoms of pain or pressure in the vagina, a feeling that there are organs emerging from the vagina, incontinence or the need to urinate frequently, impairment and the vagina hurting during sex.

Treatment always tended to be conservative starting off with exercises to tone the muscles in the pelvic floor. Failing that a support device called a pessary was inserted. This is removable by the patient.

Surgery is contra indicated if the woman still intends to bear children and is a fairly drastic procedure as one is dealing with a lot of sensitive organs down there that are moving out of place. But when the case is severe enough or the woman is past childbearing surgery may be undertaken.

In roughly a quarter of these cases an implant of transvaginal mesh was inserted beneath the vaginal wall, posteriorly or interiorly or both, to assist strengthen and support the vaginal wall and the muscles surrounding it. The device is a fairly rigid tape that once inserted allows the tissue to grow through and around it. Thus it is a permanent insertion. Recovery was fairly rapid sometimes aided by the temporary use of a pessary and, given the trickiness of the surgery involved was usually successful in the medium term.

In October 2008 however the FDA issued an advisory safety warning that there had been over 1000 reports of adverse complications from transvaginal mesh operations. It said that it was continuing to monitor. Then on 13 July 2011 the FDA issued another warning. The Vaginal Mesh FDA Warning is a statement of serious concern. In it it states that adverse consequences are being reported; principally the corrosion of the vaginal wall allowing the mesh to protrude and be exposed in the vagina. In addition or instead there occurs a soreness during sex, pain, infection and abnormal bleeding being reported as complications.
Once it is in place, the surrounding tissue starts growing through it and any attempt at removal is a very complex procedure which may not fix the issue. At the outset it was stated that this was a permanent fitment.

Anybody who is experiencing Vaginal Mesh Implant problems ought consult with an attorney. Vaginal Mesh Injury is a serious condition that may lead to a great deal of pain and discomfort in the future. Although the attorney is unable to help cure the problem they will assist you if there is a case to be made of a tort against the medical device manufacturer.