FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.
Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.
However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.
Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market. For further information on the recalled products, please visit the FDA Medical Device Recall website.
We are continuing to analyze and evaluate incoming reports of adverse events, and are speaking with patients, surgeons and researchers. We will inform the public as new information becomes available.
Before having a hernia operation, be sure to let the surgeon know if you’ve had a past reaction to materials used in surgical mesh or sutures, such as polypropylene.
There are also certain questions you should consider asking your surgeon:
In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product.
You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
Updated October 21, 2008
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