Hernia Mesh Complications – Is the FDA Watching? Part I
November 28, 2012 ~ The U.S. Food and Drug Administration (FDA) has been updating pages on mesh used for hernia repair.
Unlike transvaginal mesh, also made of plastic polypropylene, there is no Health Notification or Safety Warning on hernia mesh. That means there are no active lawsuits involving hernia mesh, but injuries are coming into the agency nonetheless.
For example in its updated November 20, page, the FDA reports it has received reports of complications associated with hernia mesh such as:
*Adverse reactions to the mesh
*Adhesions (when loops of the intestines adhere to the mesh or each other)
*Injuries to nearby organs, nerves or blood vessels
*Additional complications with or without mesh can include infection, chronic pain and hernia recurrence.
“Since the 1990s, there has been an increase in mesh-based hernia repairs – by 2000 non-mesh repairs represented less than 10 percent of groin hernia repair techniques.”
That may explain why, at least anecdotally, there appears to be an increase in hernia mesh complications. MDND receives calls frequently from patients who have a diminished quality of life after a surgical mesh implant for hernia repair. See Kristina Graham’s story in Part II (here).
This woman, who is represented by a lawyer and can’t be identified, wrote MDND to say both she and her husband have Atrium CQUR hernia mesh, which is a polypropylene mesh coated with “Omega 3 Bioabsorbably Oil Fatty Acid (03FA). See product here.
“Its been 11 months and my husband is still suffering. One implant, one removal, one more implant and a massive infection which nearly took his life. now needs a third very difficult surgery to remove the second implant. Loss of over 96,000 a year income form our business, loss of life as he knew it, constant pain. Its not a pretty picture.”
Complications can include pain, nerve entrapment, reduced movement, and a foreign object reaction that can include fever, swelling, and general malaise.
Synthetic Hernia Mesh
Mesh is either synthetic – a knitted material or non-knitted sheet. It may be absorbable, or non-absorbable or a combination of both. Non-absorbable mesh, which is mostly synthetic, will stay in the body indefinitely. It is a permanent implant and difficult to remove.
Animal-Derived Hernia Mesh
Animal-derived mesh can be made from animal tissue, such as the intestine or skin of a pig (porcine) or cow (bovine) that is processed and sterilized. Animal-derived mesh is absorbable.
Over time, absorbable mesh will degrade and lose strength while new tissue growth takes over to strengthen the repair.
With or Without Mesh – Hernia Repair Complications include:
*Tissue that stick together (adhesion)
*Blockage of large or small intestine (obstruction)
*Abnormal connection between organs, vessels, or intestines (fistulas)
*Fluid build-up at the surgical site (seroma) and perforation or a hold in neighboring organs or tissues
The FDA says it has received reports of:
Perforation which can lead to sepsis or poisoning of the blood stream and is potentially fatal
Recalled Hernia Mesh
The FDA update says “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.”
This is perplexing because besides the largest hernia mesh recall for Kugel mesh, there have been very few recalls of hernia mesh with the exception of a few manufacturing lots recalled over mislabeling and/or sterility issues.
More than 2,000 lawsuits were filed against C.R. Bard, maker of the Composix Kugel Mesh hernia patch which was recalled three times between 2005 and 2007 because the memory ring broke and could cause serious perforations. The company redesigned the Kugel patch and reintroduced it in the market through the 510(k) approval process. The FDA Kugel mesh recall December 2004 is here. The 2005 Kugel mesh recall is here.
Besides Kugel, the Proceed surgical mesh had Ethicon recall 18,270 lots in January 2006 when the polypropylene delaminated from the mesh, opening up the patient to the possibility of fissures and adhesions.
The FDA report is here.
The only other large hernia mesh recall was in September 2005 by LifeCell Corporation over its AlloDerm mesh. It was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.
The remainder of mesh recalls have been limited to small numbers of mesh due to sterility or mislabels.
Part II continues here.