Although the medical community initially heralded surgical mesh as a fantastic new way to repair hernias, the high numbers of complications and adverse events have resulted in several types of hernia mesh being recalled. In many cases, the hope of shorter surgeries, faster recoveries, and a lower recurrence of repeated hernias that hernia mesh promised were not the reality.
Surgical Mesh Implant FDA Recalls
During the last 15 years, more than 200,000 units of hernia mesh have been the subject of FDA recalls and withdrawals from the market. Here are some of the different brands of hernia mesh that have been recalled:
On January 4, 2006, Ethicon initiated a recall of 18,270 of its polymeric surgical mesh, PROCEED, a mesh product made of oxidized regenerated cellulose (ORC) fabric and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh. Ethicon designed the sterile, thin, flexible laminate mesh to repair hernias and other problems with fascia tissue.
Ethicon recalled the product from all 1,070 hospitals and distributors that had supplies of the mesh because the mesh could delaminate, meaning that the multiple layers could separate. When the layers separated, the polypropylene layer could come into contact with the bowel and increase the risk of adhesions and bowel fistulization.
Ethicon PROCEED – another recall
Ethicon initiated a recall of some of its PROCEED surgical mesh on October 18, 2010. The mesh, sold for use in hernia repair surgery, contained a nonconforming material or component that could cause it to delaminate. Delamination can cause the same problems outlined in the previous Ethicon PROCEED recall. Ethicon instructed all customers to remove the recalled product from their inventories and return them to Ethicon for a free replacement.
Bard Composix Kugel Mesh
On February 22, 2006, Davol, Inc., a subsidiary of C.R. Bard, Inc. initiated a recall of six types of hernia repair mesh devices, the Bard Composix Kugel Mesh patches, because the memory recoil ring could break and cause perforation of the bowel or chronic enteric fistula. Bard recalled:
- 31,761 units of the 8.7” x 10.7” oval patches
- 31,761 units of the 10.8” x 13.7” oval patches
- 3,069 units of the 6.3” x 12.3” oval patches
- 25,890 units of the 5.4” x 7” oval patches
- 31,761 units of the 7.7” x 9.7” oval patches
- 21,547 units of the 4.5” circle patches
The Atrium Medical Corporation initiated a recall on November 22, 2017 of some of its ProLite Mesh polymeric surgical mesh for the repair of hernia, traumatic or surgical wounds and chest wall reconstruction. Atrium reported to the FDA that they had packaged an incorrect ProLite Mesh configuration under the wrong product codes and lot numbers. Atrium told healthcare providers to examine their inventory, remove the products, quarantine them, and return them to Atrium.
EXP Pharmaceutical Services initiated an FDA recall of two sizes of a surgical mesh product, 15 x 15 cm and 10 x 15 cm, on February 11, 2015. EXP had repackaged polymeric surgical mesh that Ethicon manufactured. EXP notified its customers to recover and quarantine all of the products shipped by EXP between April 26, 2014, and December 9, 2014. EXP had failed to register with the FDA or have any quality control system.
Recent Recalls of Mesh Products Used in Hernia Repairs
The FDA is seeing many more recalls of mesh products used in hernia repairs. There have been over 200 recalls of various surgical mesh products. Some examples include:
- Acell, Inc's Gentrix Surgical Matrix Thick mesh because it failed to meet the company's tensile strength specifications.
- Covidien, LLC's Parietex Composite Parastomal Mesh because of mesh failure several years after implantation.
- AROA Biosurgery, LTD recalled 21 of its Ovitex surgical mesh products for degradation of the material.
Complications and Side Effects of Hernia Mesh
Some common complications of hernia mesh include:
- Chronic pain
- Hernia recurrence
- Bowel perforation
- Adhesions (scar tissue that “glues” your organs together)
- Blockage or obstruction of the small or large intestine
- The mesh shrinks, painfully pulling the surrounding tissue out of place.
- The mesh moves from the original site to somewhere else in your body.
If you have experienced any of these symptoms after a hernia repair – even years later – get a medical evaluation right away and talk to a hernia mesh lawsuit attorney. It can be possible, under certain circumstances, to have the mesh removed surgically. You could develop life-long organ damage from the hernia mesh, so do not ignore the symptoms.
At Tosi & Rose, we care about your health and well-being. We are passionate about fighting for people who have suffered harm at the hands of others. We will work hard to get you all the compensation you deserve.
We handle hernia mesh lawsuits on a contingent fee basis, which means that you do not have to pay upfront legal fees. Our fees will come out of the settlement or award at the end. Call us today at 888-311-8292 for a free consultation.