The FDA Still Has No Warning About Hernia Mesh

In 2011, the U.S. Food and Drug Administration (FDA) issued a Safety Communication to warn the public about polypropylene mesh used to treat pelvic organ prolapse (POP).

After originally stating in 2008 that complications from POP mesh were “rare,” the agency reversed itself three years later announcing that the growing number of complication reports associated with POP mesh were “not rare.”

The FDA began adding restrictions to the use of POP mesh suggesting it be used as a last resort because the benefits did not outweigh the risks.  

In 2012, the FDA required post-approval monitoring to assess how women were faring post-POP mesh implant.  

Finally, the FDA decided that POP mesh, which is larger than incontinence mesh and the subject of tens of thousands of lawsuits, should become a class III medical device. That is the highest risk medical device and requires clinical trials before it can be cleared for marketing.

As it now stands, any new POP mesh will have a higher bar to entering the market than in the past.

The same is not true for hernia mesh, even though it’s made from the same polypropylene. The FDA last updated its Hernia Mesh page in February 2018.

A hernia occurs when a portion of the intestine or fatty tissue squeezes through a weak spot in the abdominal wall, the muscle or connective tissue.  Depending on where that occurs, hernias have different names:

*Inguinal~ occurs in the inner groin

*Femoral~ in the upper thigh or outer groin

*Incisional~ occurs through an incision or scar

*Ventral~ Occurs in the abdominal or ventral wall

*Umbilical~ occurs at the belly button

*Hiatal~ occurs inside the abdomen along the upper stomach

Among the options for treatment are watchful waiting- that is- doing nothing and waiting to see if the problem gets worse. Often it does not.

A surgeon can choose a laparoscopic or open repair. Both can be performed with or without polypropylene surgical mesh.

What’s missing from the FDA page is any warning about complication rates and risks.

Instead, the agency promotes the use of surgical mesh suggesting it may “improve patient outcomes through decreased operative time and minimized recovery time.”

That despite the acknowledgement that complications include pain, infection, recurrence, adhesion, perforation and obstruction.

Instead, the FDA suggests the complications maybe due to “recalled mesh products” especially as the “main cause of bowel perforation and obstruction complications.”

That does not make sense when you consider the market withdrawals/recalls of hernia mesh so far.

Bard Davol recalled Composix Kugel mesh in 2005, Ethicon’s Proceed surgical mesh was recalled in 2010 (one lot and 18,000 units); Atrium C-Que Edge remains on the market but one lot was recalled in 2013; Ethicon’s Physiomesh was recalled in 2016; some Atrium ProLite Mesh was recalled in 2018 as was some Versatex Monofilament by Sofradim.

When we do the math, we see hernia mesh makers have recalled more than 211,000 units from the market since 2005.

However, with more than one million hernia repairs performed each year in the States, most (90%) using mesh, the number of recalls cannot possible account for the hundreds of thousands of complications globally, thought to be as high as 12% to 30%, according to a recent British Medical Journal (BMJ) report.