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FDA Issues Public Notice Regarding Transvaginal Mesh Implant Surgery

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The Food and Drug Administration has issued a public notice encouraging doctors and patients to explore alternatives to implantable surgical mesh when repairing pelvic organ prolapse and stress urinary incontinence. The conditions frequently occur after childbirth and pregnancy, and in 2010, more than 75,000 women had transvaginal surgery implant surgical mesh to repair POP.

The warning comes after the FDA received over 3,000 injury reports associated with the mesh from 2005 to 2010. Three of those reports involved fatalities.

Recent studies reveal that at least 10 percent of women who received transvaginal mesh implants suffer complications related to erosion of the material within one year of surgery. More than half of those patients require additional surgery to remove the mesh.

Several factors can increase risk of complications, including the type of material used, the size and shape of the implant, shape, the surgical technique used , estrogen levels, a history of smoking, other surgical procedures undergone by the patient and the patient's overall health.

Health issues are always scary, and we often place complete trust in our health professionals. It can be confusing and troubling when a tool intended to improve your health actually causes more harm than good. Always report health concerns to your doctor, and if you believe a specific product or treatment is malfunctioning, consider reporting your problem to the FDA.

If you or a woman you know has had mesh surgically implanted, consult a doctor if any pain or symptoms occur. Your legal rights are critical, too.

CD


Richard N. Shapiro
Personal Injury & Wrongful Death Lawyer Serving Va Beach, Norfolk, Chesapeake & all of Virginia
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