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Hernia mesh is a screen-like surgical implant used to repair hernias, a condition that occurs when tissue or organs bulge through a weak spot or tear in abdominal muscle. Studies show mesh is effective at preventing hernia reoccurrence, and it is the standard for hernia repair. But, a number of these mesh products were recalled and patients report suffering from complications including infections, adhesions and bowel obstructions that require hernia mesh removal surgery.
Hernia mesh is made of animal tissue or woven synthetic plastic and resembles a piece of window screen. These pieces of mesh come in many sizes including patches or plugs. The most popular types of surgical mesh are made of synthetic plastic called polypropylene, and some may come coated with absorbable fatty acids, cellulose or collagen.
While studies show hernia mesh can prevent reoccurrence of hernias, the FDA warned the mesh may cause complications such as organ perforation, infection, nerve damage and adhesions — when loops of the intestines stick to the mesh or each other. Patients injured by hernia mesh filed lawsuits against manufacturers claiming the mesh is faulty and poorly designed. In hernia mesh lawsuits, plaintiffs say hernia mesh makers hid the risks.
After placing the mesh over the hernia defect, doctors use sutures, tacks or surgical glue to hold the mesh in place. Over time, the patient's tissue should grow into the pores of the mesh and strengthen the muscle wall.
There are two types of surgery with or without mesh to repair hernias: laparoscopic and open.
The surgeon makes small incisions and inserts surgical tools through openings. This technique typically involves a shorter healing time and less blood loss, but is more challenging to perform and costs more. Surgeons will use laparoscopic repair to fix a hernia reoccurrence because it avoids old scar tissue. Recovery time is one to two weeks and strenuous exercise is allowed after about four weeks.
The surgeon makes an incision in the abdomen near the hernia to repair the weak muscle area. Recovery time is about three weeks, and strenuous exercise is allowed after six weeks.
Surgeons may use three main techniques to repair hernias with mesh: transabdominal preperitoneal (TAPP) repair, totally extraperitoneal (TEP) repair and intraperitoneal onlay mesh technique (IPOM). Now, most surgeons use the TAPP or TEP technique.
TAPP requires the surgeon to enter the peritoneum, the thin membrane covering the abdominal organs, and place the mesh through a small incision.
In TEP, surgeons do not enter the peritoneal cavity and doctors place mesh from the outside of the peritoneum. TEP is considered more difficult to perform, but may have fewer complications.
IPOM is faster and easier to perform than TAPP or TEP and grew in popularity in the 90s. Surgeons enter the peritoneal cavity and place mesh on the inside of the peritoneum in direct contact with intestines and other organs.
According to the FDA, there are six common types of hernias, with inguinal — in the inner groin — being the most common and making up about 75 percent of all hernias.
The five other types of hernias are:
Incisional – These hernias occur through a scar or incision in abdomen, typically after another surgical procedure. It is the second most common hernia.
Femoral – These occur in the upper thigh/outer groin or the labia. These are ten times more common in women.
Ventral – These are abdominal wall hernias.
Umbilical – These hernias happen in the belly button.
Hiatal – These occur inside the abdomen and upper stomach.
Hernias occur when pressure causes part of an organ or tissue to squeeze through a weak point or opening in the muscle or connective tissue. They can occur in men, women and children. Some people are born with a weak spot, but others develop it later in life.
Risk factors for hernias include:
Symptoms may vary depending on the location of the hernia, according to the American College of Surgeons. But some of the symptoms include:
There have been a few hernia mesh recalls over the years. Some recalls were for packaging errors, but others were for poor mesh performance or reports of adverse events. The FDA announced several manufacturer recalls and issued a Safety Communication in 2014 to warn the public about adverse events linked to hernia mesh.
On August 9, 2013 the FDA announced Atrium recalled thousands of C-QUR V Patch Meshes and C-QUR Edge Mesh because the fish oil coating on the mesh could stick to the packaging and peel off.
In May 2016, Ethicon released an Urgent Field Safety Notice for Ethicon Physiomesh Composite Mesh and its Lararoscopic Hernia Kits. Though the company does not consider this a recall, it withdrew these products from the market.
According to Ethicon: “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Ethicon recalled Proceed on January 4, 2006, January 14, 2011 and April 3, 2014. According to the recall announcement, incomplete seals on the product could lead to delamination and compromised sterility.
C.R. Bard issued three class I recalls — meaning the injuries could result in death — from 2005 to 2007. Bard recalled the mesh because it could possibly lead to fistulas (abnormal connections between organs) and bowel perforation.
A number of hernia patients reported several serious complications they claim multiple brands of hernia mesh caused. Many of these patients had to have the mesh removed in several painful procedures after it punctured organs, caused infections and bowel obstructions, according to lawsuits. Hernia mesh lawyers are now investigating these claims on behalf of injured patients.