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FDA Pulls All Vaginal Mesh Products Off the Market
Megan Brooks
Disclosures April 16, 2019
The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective.
The three vaginal mesh devices available in the United States are Boston Scientific's Uphold LITE and Xenform, and Coloplast's Restorelle DirectFix Anterior.
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Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.
Megan Brooks
Disclosures April 16, 2019
The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective.
The three vaginal mesh devices available in the United States are Boston Scientific's Uphold LITE and Xenform, and Coloplast's Restorelle DirectFix Anterior.
...
Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.