Medical Devices

Surgical Mesh: FDA Safety Communication

For updated information about Surgical Mesh for Pelvic Organ Prolapse, see: Urogynecologic Surgical Mesh Implants, released July 13, 2011.

Information on Surgical Mesh for Hernia Repairs

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.

Talking to your doctor

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:

  • What are the pros and cons of using surgical mesh in my particular case?
  • If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy?
  • If surgical mesh will be used, what’s been your experience with this particular product, and with treating potential mesh complications?
  • What can I expect to feel after surgery and for how long?
Reporting complications to the FDA

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.

 

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels .

Background

A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.

Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor

Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.

Questions you should ask the surgeon before you agree to surgery in which mesh will be used:

  • What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
  • If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
  • What’s been your experience in dealing with the complications that might occur?
  • What can I expect to feel after surgery and for how long?
  • Are there any specific side effects I should let you know about after the surgery?
  • What if the mesh doesn’t correct my problem?
  • If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
  • If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?
Reporting complications to the FDA

In order to help FDA learn more about possible problems with surgical mesh, it is 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 mail or FAX.

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Page Last Updated: 06/03/2014
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