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Surgical Mesh: FDA Alerts and What They Mean For You

January 31, 2012 Defective Medical Devices, Products Liability

Last month, the Food and Drug Administration (FDA) ordered manufacturers of surgical mesh to conduct new studies of the mesh products used to treat two conditions affecting millions of women in the United States.

What is Surgical Mesh?

Surgical mesh is a woven fabric used in a variety of medical procedures. The new studies recently ordered by the FDA focus on the use of surgical mesh when used to treat two conditions: stress urinary incontinence and pelvic organ prolapse.

Stress urinary incontinence, the most common type of urinary incontinence in women, is the unintentional loss of urine during physical activity, such as coughing, sneezing, laughing, or exercise. When stress incontinence can be the result of weakened pelvic muscles that support the bladder and urethra. When surgery is deemed an appropriate treatment, mesh slings can be surgically implanted to provide lift and support.

Pelvic organ prolapse occurs when the muscles and ligaments supporting a woman’s pelvic organs weaken to the point that pelvic organs can prolapse, or slip out of place. Pelvic organs include the vagina, cervix, uterus and bladder, with the bladder being the most common organ involved in pelvic organ prolapse. Symptoms of the condition may include pelvic discomfort or pain, pressure, leakage of urine, and sexual problems. If surgery is recommended for treatment, surgical mesh can be used to provide support to the affected organ(s).

FDA Alerts

The FDA has received reports of complications that can have serious consequences as a result of mesh placement. The most frequent complications reported include erosion through the vagina, infection, pain, urinary problems, and recurrence of the prolapse and/or the incontinence. Some patients required additional surgery to address the complications.

In July of 2011, based on an updated analysis of adverse events, the FDA issued a Safety Communication to inform the medical community and patients that:

  • Serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare, and
  • It is not clear transvaginal repair pelvic organ prolapse repair with mesh is more effective than traditional non-mesh repair.

In early January, the FDA ordered 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse and 7 manufacturers of single-incision mini-slings for stress urinary incontinence to conduct new studies of their mesh products. The FDA is requiring the manufacturers to submit plans for studies that will follow women for at least three years to determine side effects and to address specific safety and effectiveness concerns related to the mesh products. The current regulatory status for mesh products for stress urinary incontinence does not require pre-market approval testing.

What Does This Mean For You?

  • If your surgeon recommends surgery for stress urinary incontinence or pelvic organ prolapse, the FDA recommends you ask your surgeon the following questions:
  • What are the pros and cons of using surgical mesh in my particular case? Can my repair be performed without using mesh?
  • If a mesh is to be used, what has been your experience with implanting this particular product? What experience have your other patients had with this product?
  • What’s been your experience in dealing with the complications that might occur?
  • What can I expect to feel after surgery and for how long?
  • Are there any specific side effects I should let you know about after the surgery?
  • What if the mesh doesn’t correct my problem?
  • If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
  • If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

If you believe you have been harmed as a result of mesh implantation, contact the law firm of Wilson Kehoe Winingham. We have over 30 years of trial and litigation experience and we have achieved positive results for many clients. In addition to highly-qualified attorneys, our team includes two on-staff registered nurses and experienced paralegals and consultants. Put our resources to work for you.

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