Strattice biological hernia mesh is a biological hernia mesh, made of pig skin, manufactured by Allergan. Biological hernia implants are usually thought to be safer than synthetic mesh products. They do not have as many of the same risks, such as shrinkage and migration. They were also reported to now have the same infection risk because they are biological, as opposed to made with a foreign substance, such as polypropylene. However, recent lawsuits are now alleging that biological hernia mesh implants may not be much safer. Specifically, LifeCell, one of the main makers of biological hernia implants, has been sued over an increased infection risk associated with its Strattice graft product.
Update – October 14, 2022- ” With dozens of Strattice hernia mesh lawsuits being filed in New Jersey state court, where the manufacturer’s U.S. headquarters are located, the state court judge presiding over the litigation has ordered parties to prepare a case for trial by January 2024. Given similar questions of fact and law raised in complaints filed throughout the state, the cases have been centralized before New Jersey Superior Court Judge John C. Porto in Atlantic County, for coordinated discovery and management.” About lawsuits
Strattice is designed using pig skin. Other biological mesh products are made using human tissue. The thought was that it would be safer because the product does not involve the insertion of any kind of plastic in the human body. Synthetic hernia mesh has proven to be anything but inert (unable to carry infection) despite the promises made by the manufacturers. Synthetic hernia mesh has shrunk, moved out of place or disintegrated in the human body. The result is that patients have suffered from organ damage and intense pain because of the foreign substance moving in their bodies.
The Chemical Solution Can Make Strattice More Dangerous for Patients
The pig mesh was designed to avoid many of those symptoms. Strattice hernia mesh is a lattice stitched out of pig skin. However, the pig skin cannot directly be sown into the human body without treatment. First, the pig skin must be preserved in a phosphate-buffered aqueous solution. The graft works through cross-linking. This process makes the graft stronger by linking together the proteins in the tissue. In addition, the mesh is processed with a supposed non-damaging proprietary processing technique that supposedly removes cells, reducing the risk of human rejection. In some ways, this seems like it defeats the purpose of having a supposed safer product because chemicals are still used.
Biological hernia mesh manufacturers charge a large premium over the cost of synthetic mesh. Surgeries with biological mesh have been reported to cost patients twice as much, both because the mesh itself costs more, and due to the more extensive efforts required to implant it into the body. The doctor must fully sew the mesh into the surrounding tissue, and the surgery can take longer than a synthetic mesh surgery.
The biological graft is supposed to degrade over time, unlike a synthetic mesh, which is supposed to be permanent. Eventually, the biological graft is supposed to be replaced by the patient’s own healthy tissue. The process is intended to be safer than the synthetic hernia mesh that has caused misery for hundreds of thousands of people worldwide.
The Specific Risks that Patients Face from Strattice
There are still risks of a foreign body response that are much the same as the synthetic mesh. The chemical treatment of the mesh still introduces something foreign into the body. Here are some of the risks that are associated with the use of biological hernia mesh:
- Adhesion
- Scarring
- Infection
In addition, biological hernia mesh does not completely eliminate the risk of migration, contraction or failure. Some patients have had to have hernia mesh revision surgery, even with a mesh that was designed to be safer.
Strattice Is a Profitable Product for Allergan
Strattice has been on the market since 2007. The lawsuits have alleged that the manufacturer of the medical device should have been aware of the risk of infection and mesh failure when they began receiving reports of complications back in 2010. However, the previous maker of Strattice continued to sell the biological mesh, building its own business to set itself up for a huge payday.
Strattice is owned by the medical device giant Allergan. The company paid nearly $3 billion to buy the company that makes Strattice, apparently believing that there is a large potential market for patients who have heard of the dangers of synthetic mesh and are willing to pay a premium price to avoid those risks. By the end of 2017, Strattice had quarterly sales between $27-30 million. As more people become afraid of hernia mesh surgery, Allergan stands to make even more money.
The Costs Associated with Strattice Mesh Failure
However, Strattice’s safety may be based on a misconception because it has dangers of its own. When patients are forced to undergo revision surgery because of infection or mesh failure, they must bear the following costs:
- The financial cost of a new surgical procedure
- Pain and suffering, both from the mesh failure and from recovering from a second surgery
- Lost wages for the time that they miss from work when they have surgery and are recovering from the procedure
Some lawsuits have even been filed by the families of patients who died from hernia-related complications after receiving a Strattice implant. For example, one widow filed a 2019 lawsuit after her husband died from recurrent complex ventral hernia, aspiration pneumonia and adult respiratory distress syndrome years after receiving a Strattice hernia mesh implant.
Although Strattice mesh does not present the same large-scale health menace as synthetic mesh, there have still been hundreds of reports of injuries that have been filed with the FDA. This number will grow as there are more surgeries performed with this type of biological material. We expect the number of Strattice lawsuits to continue to grow in the future.
We Fight Powerful Companies Like Allergan on Your Behalf
Presently, the Strattice lawsuits are in their early phases, and they are still months or years away from an initial trial. If you or a loved one have received a Strattice mesh implant and have experienced complications from the surgery, you may be entitled to financial compensation. First, you must hire an experienced product liability attorney who will work to prove that Strattice hernia mesh is defective. You can expect Allergan to put up significant legal resistance, given the company’s prior reputation of doing everything possible to shield itself from liability, even resorting to allegedly underhanded tactics. We will not back down from a large company like Allergan as we fight for your legal rights.