Clark, Love & Hutson, GP

Transvaginal mesh devices proposed as high risk by the FDA

Many women in the Houston area know the inconvenience and embarrassment associated with pelvic organ prolapse. There are various treatments that are used to help women, but one may include a defective medical device. A transvaginal mesh implant can lead to serious injury, and the FDA has proposed that they be labeled as high risk for patients.

Pelvic organ prolapse occurs when the bladder, bowel or uterus becomes weak and drops from position into the vagina. Women can suffer from urinary and defecatory incontinence, sexual function disturbance, pelvic discomfort and a reduced quality of life. It often can be an embarrassing medical condition that leads women to seek out whatever medical treatment can help.

Transvaginal mesh devices are common treatments for women with pelvic organ prolapse. In this procedure, the surgical mesh is implanted to reinforce the vaginal wall. The FDA has issued many warnings regarding this procedure, as it can lead to many unexpected side effects. The complications that can arise include the mesh eroding, bleeding, infection, pain during sex, urinary problems and organ perforation. Many of these issues would require surgery.

The FDA issued a proposal to classify the surgical mesh implants as high-risk in 2014 because of the number of women who have suffered complications. If a woman believes she has suffered because of a transvaginal mesh implant, there may be legal options. It is important to review the medical records, the defective medical product and other circumstances, in order to determine what caused the unexpected injury. Compensation may be available for pain and suffering, unexpected medical expenses, and other damages.

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