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FDA states that serious complications with transvaginal mesh are ‘NOT rare’

July 16th, 2011

The Food and Drug Administration has warned that serious complications from the transvaginal mesh patch are not as uncommon as the agency had stated in an earlier warning. In October 2008, the FDA issued a safety alert to doctors which stated that serious side effects were associated with the use of transvaginal mesh for the treatment of stress urinary incontinence or pelvic organ prolapse, but that these complications were rare.

In an updated about the safety of the transvaginal mesh patch, the FDA stated that reports of complications from the patch had risen by five times over the previous three years. The agency added that although transvaginal mesh increased a patient’s risk of side effects compared to traditional surgical treatments, patients did not receive any additional therapeutic benefit from the use of the device.

The most frequent complications reported by transvaginal mesh users included vaginal mesh erosion, severe pain, infection, pain during sex, bleeding, problems during urination and organ perforation. Many patients who were treated with the transvaginal mesh patch have been forced to undergo repeat surgeries in order to remove the surgical mesh or to correct problems with the device.

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