About 90 percent of hernia repair surgeries in the U.S. use hernia mesh. Surgeons in the U.S. use hernia mesh in one million surgeries every year. Mesh can prevent a hernia from recurring. But hernia mesh can also cause serious complications. The U.S. Food and Drug Administration blames recalled meshes for many reports of hernia mesh complications.
If you or a loved one suffered complications or injury after hernia mesh surgery, you may have legal options.
Hernia mesh reinforces torn or damaged tissue around hernias. Pores in the mesh allow tissue to grow into the device. Mesh may be made of woven fibers or pressed from a sheet of synthetic material. Manufacturers also make mesh from animal tissue. Hernia mesh comes in different shapes and sizes for different hernias.
Hernia mesh is a surgical implant that provides extra support for damaged tissue. Surgeons place the mesh across the area surrounding the hernia. It helps hold damaged tissue together and strengthen it as it heals. Surgeons attach hernia mesh with stitches, staples or glue.
A main reason surgeons use hernia mesh is to lower the risk of a hernia recurring, or coming back.
There is a high chance of hernias returning after repair surgery. Conventional hernia surgery stitches torn tissue back together. Some studies have shown that surgeries using mesh lead to fewer hernia recurrences. Others have found there are other complications that are more common with mesh.
“Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.”
A 2014 study in the Journal of the American Medical Association looked at hernia repairs. It compared conventional surgery to hernia mesh.
Its authors said using hernia mesh can decrease the chance of a hernia returning. Researchers wrote that surgical mesh strengthens torn tissues while stitches alone do not.
Hernia mesh products come in many sizes and shapes. The different designs can repair specific types or sizes of hernias.
Each type of hernia mesh may also fall into other categories. These describe how they function in the body or the materials they are made from.
Absorbable mesh degrades and loses strength over time. It is not used to provide long-term reinforcement to the repaired hernia. “As the material degrades, new tissue growth is intended to provide strength to the repair,” the U.S. Food and Drug Administration explains on its website.
Non-absorbable mesh is a permanent implant. It remains in the body indefinitely. Non-absorbable mesh is supposed to provide lasting reinforcement to the repair site.
Hernia mesh made of synthetic materials come in woven or non-woven sheets. The synthetic materials can be absorbable, non-absorbable or a combination of both. The most popular types of surgical mesh are made from polypropylene – a synthetic plastic.
At least one hernia repair technique can leave mesh in contact with the intestines. This can cause the intestines to adhere to the mesh, which can result in severe complications. Some polypropylene meshes may come coated with absorbable fatty acids, cellulose or collagen. Manufacturers claim these coatings prevent adhesions.
Some manufacturers make hernia mesh from animal tissue. They may use the intestine or skin of animals. It usually comes from a pig or cow. Manufacturers process and disinfect it. This type of mesh is also absorbable.
Dozens of companies make hernia mesh. Manufacturers range from the start-up TELA Bio to Johnson & Johnson – the world’s largest medical products company.
|Manufacturer||Hernia Mesh Product Lines|
|Atrium||C-QUR, Vitamesh, Proloop, Prolite, Prolite UltraQ|
|Bard||3DMax, AlloMaxBard Soft Mesh, Bard Mesh Sheets, Composix, Dulex, Kugel, MK Patch, OnFlex, PerFix Plug, Phasix Mesh, Phasix, Sepramesh IP Composite, Ventralex, Ventralight, Ventrio, Visilex, XenMatrix Surgical Graft|
|B. Braun||Premilene, Omyra, Optilene|
|Ethicon||FlexHD Structural, Physiomesh, Proceed, Prolene, Ultrapure, Ultrapure Advanced, Vicky, XCM Biologic|
|Gore Medical||Bio-A, Dual mesh, Micromesh, Gore-Tex Soft Tissue Patch, Sinecure|
|LifeCell Corporation||Alloderm Select, Strattice|
|Medtronic||Parietex, Permacol, ProGrip, Symbotex, Versatex|
Hernia mesh provides a lucrative market that draws in medical device makers. Grand View Research estimated the global market was worth $177 million in 2016. The market research firm predicted steady growth through 2025. The potential for profit attracts all sizes of companies.
Surgery is the only treatment that can permanently repair a hernia. Hernia mesh is used in about 90 percent of those surgeries.
Surgeons can perform repairs with or without hernia mesh. But mesh has become more common since the 1980s.
Doctors may use minimally-invasive techniques to implant hernia mesh. This is called laparoscopic surgery. It requires only small incisions. Surgeons place surgical tools through the incisions to implant the mesh.
Open repair is another technique. It requires a large incision that opens the body to the hernia. Surgeons attach the mesh to the damaged tissue then close the wound.
Recovery time is shorter for laparoscopic surgery. But the operation takes longer and is more expensive.
The U.S. Food and Drug Administration tracks reports on hernia mesh complications. Doctors and patients report complications they have experienced. Manufacturers also have to tell the FDA about reports they receive.
The FDA has analyzed thousands of these reports.
Reports also detail mesh shrinking or migrating in the body after surgery.
Thousands of people have filed hernia mesh lawsuits after suffering serious complications. A federal panel has combined lawsuits over three brands of hernia mesh into three separate multidistrict litigations (MDL). MDLs allow several similar lawsuits to move more efficiently through the legal system.
The FDA has blamed recalled hernia mesh for most cases of bowel obstruction and perforation. Many of these products are no longer on the market. But some recalled meshes are still available.
Hernia mesh manufacturers have recalled more than 200,000 units since 2005. Ethicon also ordered a “market withdrawal,” taking mesh off the market without a recall.
Atrium Medical recalls 145,000 C-QUR units
Bard Davol recalls 16,000 Composix Kugel mesh units
Ethicon recalls 18,000 Proceed mesh units
Bard Davol recalls 31,000 Composix Kugel mesh units
Ethicon removes all Physiomesh Composite Mesh from the market
Alternatives to hernia mesh include at least five surgical procedures. All involve stitching the damaged tissue back together. But each uses a different method to repair hernias.
In some cases, doctors may recommend “watchful waiting” before hernia surgery. The doctor will monitor the patient’s condition until it requires surgery. Watchful waiting is an option if the patient exhibits no signs or symptoms. People should only consider this alternative if their doctors recommend it.
Please seek the advice of a medical professional before making health care decisions.
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