Hernia Mesh and the FDA’s Allegedly Slow Reactions to Complaints

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Hernia mesh lawsuits are on the rise and are being filed across the United States in state and federal courts. Adverse events from thousands of incidents involving pelvic mesh and bladder sling occurrences are also mounting. This begins to show a pattern linking specific injuries with certain hernia mesh products. A U.S. Food and Drug Administration (FDA) investigation uncovered design flaws in numerous hernia mesh products currently on the market.

Potentially Defective Hernia Mesh Products Remain on the Market

There are over 100,000 hernia mesh products implanted every year in the U.S. Many of the most dangerous hernia meshes remain on the market and have not been withdrawn or recalled by the FDA. The FDA allegedly continues to quickly approve untested hernia mesh products, which benefits the medical device manufacturers and may hurt the general public. Bowel obstructions and severe infections are common complications associated with hernia mesh.

When a product is shown to be defective, severely injuring thousands, the FDA is apparently slow to take action. The hernia mesh manufacturers allegedly know of the potentially life-threatening complications their products may cause, but do not warn the public or medical community.

National law firm Parker Waichman LLP has extensive experience and success in medical device litigation, including hernia mesh implants. The firm’s attorneys are available to answer legal questions from individuals seeking information for a potential lawsuit.

FDA Communication on Hernia Surgical Mesh Implants

In April of 2016, the following excerpt is from an FDA article: “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”

One month later, in June, the manufacturer of the Physiomesh, Ethicon, a subsidiary of Johnson & Johnson removed the hernia mesh due to high rates of complications. Ethicon continues to deny that the Physiomesh was subject to a hernia mesh recall, but does admit that they withdrew the product from the market. To date, there have been very few hernia mesh products actually recalled and the majority of complaints that were reviewed are products that have not yet been recalled, or have simply been “pulled from the market.”

Polypropylene Controversy

Many hernia mesh products contain a certain kind of plastic known as polypropylene, the same material that is used to make a variety of non-medical products, such as soda bottles and fishing lines. It is popular for use in so many commercial products for the main reason that it is very inexpensive.

There is a Polypropylene Materia Safety Data Sheet (MSDS) that states “Prohibited Uses: Applications involving permanent implantation into the body.” However, the manufacturers of numerous hernia mesh products continue to use polypropylene and deny that polypropylene degrades and contracts.

Whereas larger hernias may need mesh to repair the hernia, there are apparently over 50 different hernia mesh products to choose from, ranging from plastics to gels to pig skins. Inguinal (groin) hernias are usually smaller and can be repaired by a skilled surgeon without the use of mesh.

Alternatives to Hernia Mesh

  • Shouldice Repair: A two-layer suture only hernia repair utilizing the patient’s fascia (a thin sheath of fibrous tissue enclosing a muscle or other organ) and tendon.
  • McVay Repair: Abdominal tendons are sutured to the inguinal ligament
  • Bassini Repair: A suture inguinal hernia repair that preserves the spermatic cord
  • Desarda Repair: A suture only repair using multiple layers of fascia

Smaller hernias, typically caused by laparoscopic surgery, do not require mesh to repair and can easily be repaired with sutures by an experienced surgeon. There can be a high rate of hernia recurrence, both with sutures and with mesh. With mesh failure, abdominal tissue and muscle typically adheres to the mesh and must be removed with it.

Types of Hernias

  • Incisional: At an old surgical incision
  • Umbilical: Near the belly button
  • Inguinal: Groin
  • Femoral: High in the thigh
  • Recurrent: Previous hernia site
  • Bilateral: Both left and right sides

Hernia mesh often causes life-threatening complications. Hernia mesh may erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. Mesh failure may often cause systemic infection. High rates of dental infections associated with mesh failure have recently been observed.

Hernia mesh is used to repair both ventral (abdominal) hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is more likely to cause injuries such as infection than a non-coated hernia mesh.

Legal Information Regarding Mesh Implants

If you or someone you know has suffered injuries associated with a hernia mesh product, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/hernia-mesh-fdas-allegedly-slow-reactions-complaints/

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