Hernia Mesh Side Effects & Warnings
About 800,000 hernia repair surgeries are performed every year in the U.S., 90% of which use hernia mesh. Hernia mesh is a surgical device which is used during hernia repair surgery to stabilize abdominal tissues.
Hernia mesh is a type of mesh that can be implanted into muscles or other tissue to provide support and stability. It is constructed out of natural or synthetic polymers or plastics. Plastics like polypropylene that can be used in construction of hernia mesh may degrade after implantation. Hernia mesh is constructed of the same material which has been used in other surgical products including transvaginal mesh and bladder slings. Like hernia mesh, many of these products have resulted in serious injuries after implantation.
Hernia mesh is made by a number of medical device manufacturers including:
- C.R. Bard
- Atrium Medical
- Ethicon / Johnson & Johnson
- Gore Medical
- LifeCell corporation
- B. Braun Melsungen
The larger hernia mesh manufacturers like C.R. Bard, Atrium Medical and Johnson & Johnsons’ Ethicon division have faced over 50,000 lawsuits due to serious injuries caused by their mesh products. Several companies which also manufacture urogenital mesh products have also faced thousands of transvaginal mesh and bladder sling lawsuits.
Hernia Mesh Side Effects
In addition to normal post-surgical effects such as pain and swelling which go away after the recovery period, hernia mesh may cause more severe or serious side effects including:
- Severe or chronic pain
- Tissue adhesion
- Mesh migration
- Mesh shrinkage
- Bowel blockage
- Organ perforation
- Hernia recurrence
When hernia mesh causes serious complications, many patients require additional surgery to remove the defective mesh, correct or stabilize the original hernia and to repair any new damage that has occurred due to mesh problems. Each additional surgery will place the patient at new risk for surgical complications.
Hernia Mesh Development
Surgical mesh for hernia repair was first introduced in the 1950s but it was not widely used until the 1980s when the Lichtenstein repair procedure became popular. The number of procedures using hernia mesh has continued to grow. Even though serious injuries continue to occur, today about 90% of the 800,000 procedures performed yearly in the U.S. are done with hernia mesh.
Hernia Mesh FDA Recalls
Beginning in about 2000, serious concerns began to emerge and despite thousands of reports of serious adverse events, medical injuries and deaths, few hernia mesh products have been recalled by the FDA.
In 2006, a Class I recall, indicating a high chance of serious harm, was issued by the FDA for C.R. Bard’s Composix Kugel Patch. Though numerous products by Bard have come under fire, most of their hernia mesh and other surgical mesh products have not been recalled and remain on the market. A similar circumstance has occurred with Johnson & Johnson’s Physiomesh Flexible Composite Mesh, produced by its Ethicon division which was withdrawn in 2016 but leaving other mesh products available.
Atrium Medical has been the target of a number of warning letters regarding manufacturing sterility and defects involving C-QUR mesh, however it remains on the market. Many other companies have faced scrutiny and though some of their products, particularly transvaginal mesh devices have been discontinued, many devices are still being sold under the original or new product names.
Hernia Mesh Lawsuits
Tens of thousands of hernia mesh lawsuits have already been filed due to injuries such as:
- Hernia recurrence
- Organ perforation
- Bowel obstruction
- Other injuries
Many of these lawsuits have already been settled but some still remain in court systems and more may be expected. An experienced hernia mesh lawyer can help determine eligibility for compensation through a hernia mesh lawsuit.
Read more about hernia mesh lawsuits.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.