A medical business by the name of Ethicon produces a hernia patch called the Physiomesh Composite Mesh. This medical device is used for facial diseases requiring bridging or strengthening materials, such as minimally invasive hernia repair operations.
You get a hernia when your bowel, organ, or fatty tissue pushes through the surrounding connective or muscle tissue. 400,000 ventral hernia repairs are performed annually, the majority laparoscopically.
Fixing hernias would seem to be a lucrative business. Here come the hernia mesh products. These items have advanced significantly, but they are 80 years old. The many materials, sizes, densities, and other properties of these meshes enable surgeons to choose the ideal mesh for a certain patient or treatment.
For all but the smallest hernias, most surgeons employ a mesh product during hernia repair surgery. The optimal prosthetic mesh product for hernia repair should resemble the abdominal wall.
Through a loophole known as 501(k), the U.S. Food and Drug Administration approved Johnson & Johnson subsidiary Ethicon. Because the medical product is “substantially comparable” to prior surgical meshes, the FDA did not examine it as it would other new items.
Thus, flexible composite mesh systems like Prolene, UltraPro, and Physiomesh were the foundation for Physiomesh.
Naturally, they have all experienced difficulties. Recalls and other actions by the FDA have been made regarding Prolene.
There are presumably several gadgets that qualify under section 501(k). However, it is amazing how the product history in mass tort litigation always starts with “the product gained 501(k) approval.”
Physiomesh features a distinctive five-layer structure. Two layers of poliglecaprone-25 (also known as “Monocryl”) film are placed on top of two layers of polydioxanone (also known as “PDS”) film. The latter has a polypropylene mesh coating.
Although Physiomesh has received 501(k) approval, this hernia repair product has a revolutionary design. There is no other hernia repair device that uses this design.
The multi-layer covering was promoted to patients and medical professionals as a breakthrough that would lessen adhesions and irritation while facilitating mesh absorption into the body.
Mesh comprised of synthetic materials that won’t dissolve is meant to stay inside the body permanently. This revised layout was intended to achieve that goal more effectively.
The multi-layer covering, which was intended to integrate the mesh into the body better, actually accomplished the exact reverse of what it was intended to. Some patients, however, experienced a severe inflammatory reaction.
According to the plaintiff’s attorneys, the multi-layer coating of the Physiomesh patches is cytotoxic, immunogenic, and not biocompatible.
Delays in the healing of wounds, inflammation, reactions to foreign bodies, rejection, infections, and other severe injuries, such as hernia recurrence and extra surgery, are the results.
The mesh degrades as a result of its brittleness. Additionally, there may not have been enough polypropylene exposed on this mesh, which would indicate improper integration into the abdominal cavity.
Physiomesh (including Prolene Mesh) produced higher rates of recurrence and reoperation than other comparable mesh material items designed for the same function, the researchers ultimately discovered.
Products made of Physiomesh have been recalled because of a number of potential dangers and issues. These consist of the following:
- Continual and severe discomfort
- Infection
- Injury to organs
- Mesh migration, movement, or shrinkage
- The hernia problem returning
- Additional surgery
- Intestinal obstruction
- Several other conditions
Due to these issues, individuals who suffered pain or injury as a result of the Ethicon Physiomesh products have filed lawsuits.
What Consequences Does Defective Physiomeshes Have?
According to sources, Ethicon/Johnson & Johnson released an Urgent Field Safety Notice in May 2016 on issues related to Physiomesh side effects and flaws.
Evidence indicated that patients implanted with Physiomesh during a laparoscopic repair of a ventral hernia had significantly worse results than those implanted with a comparable mesh. Ethicon/Johnson & Johnson was informed of this.
Physiomesh has associations with:
- Pain/infection
- Return of the hernia
- Adhesion (scar tissue accumulation, adhering to interior abdominal structures) (scar tissue buildup, attaching to internal abdominal tissues)
- Intestinal obstruction
- Bleeding/Perforation
- Organ injury
- Operation revision
Regulation of Physiomesh History
Through its 510k approval procedure for medical devices, the FDA granted Physiomesh approval in 2010. This procedure allows new medical devices that are substantially equivalent to those that have previously received prior market approval and simply need animal testing to be approved more quickly.
Additionally, their specific use in the abdomen was not tested. As a result, the flaws were not found until thousands of patients had the Physiomesh implanted and were experiencing the negative side effects.
Proceed mesh, which Ethicon also produced, served as the precedent for the Physiomesh, which was granted expedited FDA approval. Due to a flaw resulting in adhesions and intestinal fistulas, proceed mesh had to be recalled. Due to its incompatibility with the organic tissues of the abdominal wall, Physiomesh now leads to adhesions and hernia recurrence.
The Physiomesh should no longer be used by surgeons, according to an Urgent Field Safety Warning from the FDA. Due to its high failure rates, Physiomesh was permanently removed from the market.
Who Is Responsible for Accidents Caused by Ethicon Physiomesh Products?
A product made by Ethicon Physiomesh may result in injuries that are the fault of several parties. For instance, product liability claims have frequently been made in lawsuits brought against the producers of such goods. This is based on the possibility that the Physiomesh products are flawed.
Other parties may be held accountable when Physiomesh goods are prescribed or sold while being recalled. These professionals include physicians, pharmacists, and others who make recommendations for these kinds of goods. Hospital organizations may also be held accountable for keeping Physiomesh goods on hand or for continuing to sell them.
Ethicon Physiomesh attorneys have sued Ethicon and Johnson & Johnson around the country because their products were improperly created and constructed, causing unforeseen damage when used as was reasonably anticipated. Patients may sustain significant harm as a result of Physiomesh’s high rate of hernia recurrence, revision surgery, and other problems.
Medical expenses, lost pay, mental distress, pain and suffering, loss of enjoyment of life, and loss of consortium are all examples of damages that may be claimed in a Physiomesh lawsuit. Usually, compensatory damages are used to make up for these aspects of damages.
Punitive damages, on the other hand, are different damages that can be recovered in a case involving a defective medical device or other types of product. These are given to huge corporations as retribution, usually for behaviors like willfully concealing dangers, failing to notify consumers and medical professionals, and willfully flouting FDA regulations.
You will want expert witnesses to attest to the connection between the product and the injuries if you want to be compensated for injuries brought on by Physiomesh.
Stringent procedural rules must be followed in federal court for many complex medical device disputes that could ultimately develop into class actions or multidistrict litigation (MDL).
As a result of the harm sustained by patients who experienced issues related to the Physiomesh implanted in them during a hernia repair operation, Johnson & Johnson, the corporation that owns Ethicon Physiomesh, is currently the target of multiple personal injury lawsuits. To discuss your options if you believe you may have been harmed by hernia mesh, get in touch with a qualified personal injury attorney.
What are the Legal Recourses for Cases of Physiomesh Injuries?
A lawsuit could be filed if Physiomesh goods lead to injuries. In such litigation, the harmed party is often awarded monetary damages as the legal remedy. The amount of compensation for damages might be used to pay for hospital bills, extra surgery or medical treatments, prescription costs, and other losses like lost wages or diminished ability to make an income.
A class action lawsuit may be launched if the same problem causes harm to numerous people.
Do I Require Legal Counsel to Handle My Ethicon Physiomesh Claim?
The use of an Ethicon Physiomesh product can result in significant, even fatal, injuries.
If you have been hurt or otherwise impacted by a Physiomesh device, it may be in your best interests to seek a defective products attorney in your area. Your attorney can advise you and represent you in your legal matter.
