Hernia Mesh Lawsuit

Hernia repairs are common – more than one million hernia repairs are performed each year in the U.S.

Approximately 800,000 are to repair inguinal hernias, which occur in the inner groin, the rest can occur in other areas of the body.

A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue.

An increasing number of hernia repairs are being done via laparoscopic methods with the promise of faster recoveries and less pain, but, individuals are now coming forward noting that one of the leading hernia mesh products that have led to higher rates of recurrence and reoperations have been required to fix the damage done from the mesh.

On May 25, 2016, Johnson & Johnson issued an “Urgent Field Safety Notice” to warn of the higher rates of recurrence/reoperation after laparoscopic ventral hernia repair using the Ethicon Physiomesh Composite Mesh.

Ethicon’s Physiomesh was a leader of global sales in the laparoscopic hernia repair surgeries from the time it was brought to market in early 2010 until it was voluntarily recalled in May 2016.

Hernia mesh lawsuits are currently being filed against Johnson & Johnson, the manufacturer of the Ethicon Physiomesh Composite Mesh as a result of the injuries and complications that occurred as a result of this high rate of recurrence and reoperation.

According to Physiomesh lawsuits that have been filed in several states, Johnson & Johnson should have reported the deaths and serious injuries that occurred as a result of the Physiomesh product to the FDA — one of the most frequently used hernia mesh products.

Higher risk of recurrence of a hernia or reoperation rates with the Ethicon Physiomesh Composite Mesh were originally identified by two application-oriented outcome tools created to track nation-wide surgical outcomes after groin hernia repair.

The Danish Inguinal Hernia Database and the Herniamed German Registry allow all institutions to actively monitor the surgical quality and outcomes of products used in hernia repairs.

Both the Herniamed German Registry and Danish Hernia Database – DHDB noted higher-than-expected rate of recurrence and reoperations in patients who used Ethicon Physiomesh in their hernia repair as opposed to other mesh products.

Many of these lawsuits have been consolidated in one of two MDL dockets — Ethicon Phyiomesh Flexible Composite Hernia Mesh (MDL 2782) and Atrium Medical Corp. C-Qur Mesh Products (MDL 2753).

March 2018 — Johnson & Johnson was hit with a $35 million verdict in a Prolift pelvic mesh product liability lawsuit.

Barbara Kaiser sued Ethicon for causing low pelvic pain after being implanted with a Prolift mesh.

The lawsuit accused J&J and Ethicon of concealing the high complication rates linked to the Prolift pelvic mesh from the public.

The recalled hernia mesh was commonly the cause of bowel perforation and obstruction complications.

Once there is a migration of the mesh and particularly erosion, surgical procedures to fix the complications are generally necessary.

These surgical procedures often require a staged operation and a large recovery time.

The FDA issued a Class II recall for C-Qur Mesh in August 2013 because the device had a packaging flaw which caused it to get stuck in the inside lining making it unusable.

This mesh is manufactured by Atrium Medical Corporation.

In 2015 a government report was released finding that Atrium failed to address multiple safety violations.

In December 2016 the C-Qur hernia mesh cases were consolidated in an MDL docket 2753.

Multidistrict litigation (MDL) speeds up the process of hearing multiple lawsuits based on the same complaint.

The C-Qur hernia mesh lawsuit was filed against Atrium for failing to warn that their product could cause serious problems including high rates of infection, bowel obstructions, and allergic reactions.

This mesh is also very difficult to remove once it attaches to the bowel.

Specifically, the Omega 3 fatty acid gel coating was being called into question.

This C-Qur V-Patch was cleared by the FDA using the 510(k) clearance program which allows companies to skip rigorous pre-market research because the C-Qur mesh was similar to a mesh approved in the 1990s.

Medical devices cleared by the 510(k) program are more susceptible to lawsuits because they are not properly studied and researched before they get to market.

The FDA continues to clear medical devices using this program and all this does is benefit the manufacturers and hurts the public.

C.R. Bard’s Kugel hernia mesh implants was one of the first to be recalled.

This particular mesh was implanted over a million times since its FDA approval in the 1990s.

Unique to this mesh — it contained a ring that broke down after implantation which caused bowel and other organ perforations.

It is also made of polypropylene which is the material that has caused serious complications as well.

When this mesh is implanted, the polypropylene shrinks smaller than the size of the ring exposing it and causing it to break and perforate organs.

In laparoscopic surgical hernia repair, the surgeon makes several small incisions in the abdomen that allows surgical tools to be inserted into the opening and the hernia is repaired.

In many cases, surgical mesh is placed over the defect to reinforce the wall of the organ.

Laparoscopic surgery is often recommended because it allows individuals to get back to work quicker and generally causes less pain.

Generally, the chance of a hernia coming back after laparoscopic surgery ranges from 1 to 10 out of 100 surgeries done, but as noted in the Physiomesh lawsuits, the rate of hernia recurrence was much greater with the Physiomesh hernia patch than with other mesh products used.

Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue.

It is generally made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into a fabric.

It is important to note that Ethicon Physiomesh Recall involved only the Ethicon Physiomesh Composite Mesh product line, it did not include the Ethicon Physiomesh Open Flexible Composite Mesh Device, which remains on the market today.

The Ethicon Physiomesh Open Flexible Composite Mesh Device was FDA approved on October 23, 2014 under a 510(k) process in which it was shown by Johnson & Johnson to be “substantially equivalent” to Ethicon Physiomesh’s Composite Mesh – the very device that Johnson & Johnson just recalled.

Under a 510(k) application, the FDA does not require the device to submit clinical trials to prove effectiveness.

Instead, it is assumed to be as safe as the previous device on the market.

Since the device Ethicon submitted as “substantially equivalent” to their new mesh hernia product has been recalled, many now wonder about the safety and effectiveness of the Ethicon Physiomesh Composite Mesh.

Composite hernia mesh is the most dangerous type of mesh used for repairs and there is no reliable data on the safety of these hernia mesh products.

A majority of surgeons today are using composite mesh for hernia repairs.

The voluntary recall of the Ethicon Physiomesh Composite Mesh product has been communicated to doctors, therefore, the best thing to do is to speak to your physician and continue to follow up as instructed.

TruLaw encourages all individuals harmed by devices such as in the case of a hernia mesh to report the side effects and complications to the FDA.

Do not assume that the FDA knows about your complications!

Learn how to submit your information to the FDA.

If you believe you qualify for a hernia mesh lawsuit, we can let you know instantly and with no obligation.