Johnson & Johnson Physiomesh: The Latest on the Hernia Mesh Recall

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Hernia mesh surgeries are one of the most common surgeries performed in the United States today. Many different types of products can be used for surgical hernia repairs, including patches and plugs. Ethicon, a subsidiary of Johnson & Johnson, is the manufacturer of Physiomesh — a flexible composite mesh made of polypropylene that’s been recalled and the subject of class-action lawsuits.

If you have sustained injuries and damages as a result of exposure to Physiomesh, our experienced defective products lawyers will be able to evaluate your case, safeguard your legal rights, and help you to obtain the monetary compensation you may be entitled to.

Physiomesh Hernia Repair

A hernia occurs when an organ, intestine, or fatty tissue squeezes through a hole or a weak area in a muscle. Although various types of activities that increase abdominal pressure may potentially cause a hernia, the most common causes of hernias are as follows:

  • Obesity
  • Lifting heavy weights
  • Pregnancy

Hernias can look like an external bulge and often occur at the abdominal wall. The most common types of hernias are:

  • Ventral (located at the abdominal wall)
  • Umbilical (located at the belly button)
  • Hiatal (located inside the abdomen on the diaphragm)
  • Incisional (surgical incision or scar in the abdomen)
  • Inguinal (located at the inner groin)
  • Femoral (located at the upper thigh or outer groin)

Because hernias can reopen, surgeons may perform a procedure during which they stitch-in a mesh patch or plug to help reinforce the muscles and connective tissues.

Physiomesh Recall: Facts and Problems

The purpose of Physiomesh is to repair hernias or reinforce weaknesses in a patient’s abdominal wall, which could lead to a hernia in the first place. When a surgeon implants Physiomesh over an opening or weak spot in a patient’s abdominal wall, a strong barrier is created, which in turn prevents internal organs from squeezing through.

The FDA approved Physiomesh composite mesh in 2010. However, prior to making it available on the market, no clinical trials were performed. As a result of two studies that were undertaken in Germany and Denmark — both of which linked Physiomesh to an increased number of hernia repair procedures — Ethicon withdrew Physiomesh flexible composite mesh from the worldwide market in May of 2016.

Some of the possible complications associated with Physiomesh implants include the following:

  • Chronic or intermittent pain
  • Intestinal migration, movement, or blocking
  • Development and adherence of scar tissue
  • Organ perforation or damage to nearby organs
  • Surgical mesh migration
  • Infection
  • Recurrence or reopening of hernia
  • Need for revision or corrective surgery
  • Death

Basis for Class-Action Lawsuits

Injured patients are currently filing class-action lawsuits against hernia mesh manufacturers, including Ethicon, based upon products liability and negligence theories of recovery.

In order to prevail on a products liability theory of recovery, there must be a defect in the product’s manufacture or design — or the warnings provided for the product must be inadequate or incomplete. Moreover, the defective product must be the proximate cause of the user’s injuries and damages. Under a negligence theory, the manufacturer must have ordinarily breached a duty to the public, proximately resulting in injuries and damages.

In the case of Physiomesh, injured patients are alleging that Physiomesh was defectively designed by Ethicon with a lower level of elasticity when compared with competing hernia mesh products on the market, resulting in poor attachment to the injured patient’s abdominal wall, retraction, contraction, and ripping. All of these can result in serious health consequences to the patient.

Moreover, injured patients allege that Ethicon negligently and prematurely placed Physiomesh on the market prior to undertaking extensive testing, research, or clinical trials, proximately resulting in serious injuries and damages to patients.

The most common types of potential damages available to injured patients in Physiomesh class-action lawsuits include the following:

  • Payment of medical bills
  • Payment of lost wages
  • Damages for loss of earning capacity
  • Damages for past, present, and future pain and suffering
  • Damages for past, present, and future mental anguish or emotional distress
  • Payment of costs for further corrective surgeries

Use of Physiomesh hernia mesh during hernia repair procedures has been shown to cause serious injuries and complications to patients — the most common of which is the need for corrective hernia mesh repair surgery. Injured patients may be able to recover damages under both a products liability and a negligence theory of recovery.

Contact our Ohio Hernia Mesh Lawyers

If you or someone you love has been exposed to Physiomesh during a hernia repair surgery and injuries resulted, you may be entitled to legal compensation and monetary damages. Our experienced defective products attorneys at Dyer, Garofalo, Mann & Schultz can review the facts and circumstances of your case with you and take the necessary legal actions to help you obtain compensation for your injuries. We’ve handled several medical devices cases, such as those against Johnson & Johnson DuPuy hip implants, da Vinci Robotic Surgery, and transvaginal mesh.

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