FDA Halts Surgical Mesh Sales in USA

FDA Halts Surgical Mesh Sales in USA

The US Food and Drug Administration (FDA) has banned the sale and distribution of surgical mesh products in the United States effective immediately. This decision comes in the wake of an increasing number of mesh-related lawsuits and negative reports about the products commonly used to repair transvaginal and pelvic related health issues.

In 2016, the FDA reclassified surgical mesh products while communicating the safety risks involved. These actions led to a decline in mesh sales and prompted some manufacturers to voluntarily recall and discontinue their mesh products.

Companies that have continued to manufacture surgical mesh products now have to comply to new FDA requirements. The two remaining manufacturers, Boston Scientific and Coloplast, have 10 days to provide the FDA with a plan to recall their mesh products.[1]

These regulatory changes are in stark contrast to the recent NICE decision in the UK to remove the ban on mesh products. While the UK acted earlier than the FDA by pausing mesh implants in 2018, they recently announced they were lifting that ban provided specific conditions are met.

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