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Hernia Mesh

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.

Have you developed complications after receiving a hernia mesh implant?You might be entitled to compensation.

How Hernia Mesh is Made

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.

Hernia Mesh Surgery

Doctors may perform hernia repair surgery with or without mesh. Hernia repair surgery with mesh is called hernioplasty, without mesh it is called herniorraphy. Because hernias have a high rate of reoccurrence, surgeons started using mesh to strengthen the repair. Hernia repair with mesh is now the standard procedure. Depending on the location of the hernia, recovery time can vary.

The surgical mesh acts as flexible scaffolding to repair muscle walls and prevent organs from coming through. Small pores in the mesh allow tissue to grow into the implant. Most mesh repairs are permanent, meaning the implant will remain in the body for the rest of the patient's life.

Types of Hernia Mesh Surgery

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.

Laparoscopic

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.

Open Repair

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.

Hernia Repair Techniques

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.

1

TAPP

TAPP requires the surgeon to enter the peritoneum, the thin membrane covering the abdominal organs, and place the mesh through a small incision.

2

TEP

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.

3

IPOM

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.

Hernia Mesh Surgery Complications & Side Effects

Depending on the surgical technique and type of mesh, complications and side effects following hernia repair surgery may vary. Patients generally recover quickly and do well after surgery, according to the FDA. But, the agency also received reports of adverse events.

According to the FDA, reports of adverse events include:

Pain & Bleeding

Infection

Hernia reoccurrence

Adhesions, scar tissue that sticks together

Mesh shrinkage

Fistulas, abnormal connections between organs

Seroma, fluid buildup at the surgery site

Bowel or intestinal blockage

Organ perforations

Nerve damage

Autoimmune reactions to mesh

Mesh migration and rejection

Types of Hernias

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.

Hernia Risk Factors

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:

  • Obesity
  • Diarrhea or constipation
  • Lifting heavy objects
  • Persistent coughing
  • Sneezing
  • Pregnancy
  • Old age
  • Poor Nutrition
  • Chronic Straining
  • Connective Tissue Disorders

Hernia Symptoms

Symptoms may vary depending on the location of the hernia, according to the American College of Surgeons. But some of the symptoms include:

  • Bulge in the groin, scrotum or abdominal area that increases in size with coughing or straining
  • Numbness or irritation around the hernia site.
  • Mild pain or pressure at hernia site.
  • Sharp abdominal pain and vomiting may mean part of the intestines slipped through the muscle wall and are strangulated. This means blood flow to part of the intestines is cut off. Strangulation is a surgical emergency.

FDA Hernia Mesh Recalls

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.

Atrium C-QUR 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.

Ethicon Physiomesh

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 Proceed Surgical Mesh

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.

Bard Davol Kugel Hernia Patch Mesh

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.

Mesh Lawsuits

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.

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  1. FDA. (2013, August 9). Class 2 Device Recall CQUR Edge Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=119924
  2. Zogbi, L. (2011). The Use of Biomaterials to Treat Abdominal Hernias. Retrieved from http://www.intechopen.com/books/biomaterials-applications-for-nanomedicine/the-use-of-biomaterials-to-treat-abdominal-hernias
  3. Sherwinter, D.A. et al. (2016). Laparoscopic Inguinal Hernia Repair. Retrieved from http://emedicine.medscape.com/article/1534321-overview
  4. Society of American Gastrointestinal and Endoscopic Surgeons. (n.d.). Laparoscopic Inguinal Hernia Repair. Retrieved from https://www.sages.org/publications/patient-information/patient-information-for-laparoscopic-inguinal-hernia-repair-from-sages/2/
  5. FDA. (n.d.) Hernia Surgical Mesh Implants. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  6. Landro, L. (2012, February 28). A Secret for Patients Undergoing Hernia Repair. Retrieved from http://www.wsj.com/articles/SB10001424052970203833004577249344022834000
  7. FDA. (2013, August 9). Class 2 Device recall CQUR VPatch Mesh. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925
  8. FDA. (2014). Surgical Mesh: FDA Safety Communication. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm
  9. Brown, C.N. & Finch, J.G. (2010). Which mesh for hernia repair? Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3025220/
  10. Gore Medical. (n.d.) Hernia. Retrieved from https://www.goremedical.com/conditions/hernia
  11. American College of Surgeons. (2016). Groin Hernia Repair. Retrieved from https://www.facs.org/~/media/files/education/patient%20ed/groin%20hernia.ashx
  12. Wake, B.L. et al. (2005). Two different laparoscopic techniques for repairing a hernia in the groin. Retrieved from http://www.cochrane.org/CD004703/COLOCA_two-different-laparoscopic-techniques-for-repairing-a-hernia-in-the-groin
  13. Ethicon. (2016, May 25). Urgent Field Safety Notice: Ethicon Physiomesh Flexible Composite Mesh (All Product Codes).
  14. Michigan Surgery. (n.d.). A Brief History of Hernia Surgery. Retrieved from http://michigansurgery.com/general-surgery/hernia-surgery/a-brief-history-of-hernia-surgery/
  15. FDA. (2006, January 4). Class 2 Device Recall. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43417
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