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Medical Devices
What Hernia Mesh Has Been Recalled?
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Quick Insights
- Several hernia mesh products have been recalled. The most high-profile of these are Ethicon PROCEED, certain sizes of the Bard Composix Kugel Mesh, and certain batches of the Atrium ProLite mesh.
- Defensive hernia meshes can have extremely serious effects on the patient’s health and cause complications like hernia recurrence, bowel perforation, and organ adhesions.
- If you or a loved one suffered any complications from a defective hernia mesh, contact Tosi Law to discuss your eligibility for financial compensation.
Although the medical community initially heralded the use of surgical mesh as a groundbreaking way to repair hernias, the high number of complications and adverse events have dampened their excitement.
Over time, it became clear that the reality of hernia mesh repair effectively negated the benefits – shorter surgeries, faster recoveries, and fewer cases of hernia recurrence – that doctors were expecting.
In fact, the sheer number of complaints logged against these devices even forced the FDA to take certain types of hernia mesh products off the market by recalling them.
Surgical Mesh Implant FDA Recalls
Since 2006, more than 200,000 units of hernia mesh have been the subject of FDA recalls and withdrawals from the market. Among these are the following products:
Ethicon PROCEED
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. This sterile, thin, flexible laminate, nonabsorbable polypropylene mesh was designed to repair hernias and other problems with fascia tissue.
Ethicon recalled the product from all 1,070 hospitals and distributors after it became clear that the mesh could delaminate, meaning that its layers could separate. This would typically result in the polypropylene layer coming into contact with the patient’s bowel and increase the risk of adhesions and bowel fistulization.
Ethicon PROCEED – 2010 recall
Ethicon initiated a limited recall of its PROCEED surgical mesh on October 18, 2010. The product contained a nonconforming component that risked mesh delamination and additional bowel interference for the patient, similar to the 2006 issue mentioned above.
Ethicon instructed all customers to remove the recalled products 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., recalled six different types of the Bard Composix Kugel Mesh patch. The main reason for the recall was to address the risk of the product’s memory recoil ring breaking and perforating the patient’s bowel or causing chronic enteric fistula.
The six recalled products were:
- 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
Atrium ProLite
On November 22, 2017, Atrium Medical Corporation recalled certain batches of its ProLite polymeric surgical mesh products. These meshes are used for hernia and surgical wound repair as well 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.
Ethicon Physiomesh
On February 11, 2015, EXP Pharmaceutical Services initiated an FDA recall of two sizes of Ethicon’s surgical mesh product, 15 x 15 cm and 10 x 15 cm.
EXP had failed to register with the FDA or have any kind of quality control system in place for this repackaged polymeric surgical mesh. EXP notified its customers and instructed them to recover and quarantine all of the products that had been shipped between April 26, 2014, and December 9, 2014.
Recent Recalls of Mesh Products Used in Hernia Repairs
The FDA is seeing several more hernia mesh product recalls. There have been over 200 recalls of various surgical mesh products. Some examples include:
- Acell, Inc.’s Gentrix Surgical Matrix Thick mesh failed to meet the company’s tensile strength specifications.
- Covidien, LLC’s Parietex Composite Parastomal Mesh exhibited a tendency to fail several years after implantation.
- AROA Biosurgery, LTD recalled 21 of its Ovitex surgical mesh products after it was revealed that the material exhibited a dangerous tendency for degradation.
Complications and Side Effects of Hernia Mesh
Some common complications of hernia mesh include:
- Chronic pain.
- Inflammation.
- Infection.
- Hernia recurrence.
- Bowel perforation.
- Adhesions (scar tissue that “glues” the patient’s organs together).
- Blockage or obstruction of the small or large intestine.
- Mesh shrinkage and the resultant displacement of surrounding tissue.
- Mesh migration from the implantation site to another location in the body.
If you have experienced any of these symptoms after a hernia repair—even years later— it’s extremely important to undergo a medical evaluation as soon as possible. Under certain circumstances, it may be possible to have the mesh removed surgically. However, you could develop life-long organ damage from the hernia mesh, so do not ignore the symptoms.
Once your health has been stabilized, it’s important to contact a hernia mesh lawsuit attorney to discuss filing a lawsuit against the hernia mesh manufacturer and obtaining compensation for your suffering and financial losses.
At Tosi Law LLP, we care about your health and well-being. We are passionate about fighting for people who have suffered harm at the hands of negligent pharmaceutical companies.
We handle hernia mesh lawsuits on a contingency fee basis, which means that our fees will come out of the settlement or award and that you will never pay any legal fees upfront.
Call us today at 888-311-8292 for a free consultation.
Call Tosi Law if You Have Questions
If you or a loved one has developed multiple myeloma or any other type of cancer after being exposed to Roundup, you could be entitled to compensation. Please call Tosi Law LLP at 888-311-8292 for more information. Our defective product lawyers are ready to help you file a Roundup lawsuit.
