Johnson and Johnson and its subsidiary Ethicon are under fire over the alleged side effects of its blockbuster polypropylene mesh medical device which is used to surgically treat abdominal and inguinal hernias.
Ethicon Physiomesh Injury, Infection Lawsuits on the rise
Sarah Gilman, from Florida recently filed a personal injury and defective product liability complaint against Johnson & Johnson and Ethicon. Gilman alleges severe complications after Physiomesh hernia surgery resulted in the plastic mesh engulfing her internal organs and had to be removed.
Gilman filed in the U.S. District Court for the Middle District of Florida, claiming that the Ethicon Physiomesh was defectively designed and unreasonably dangerous for hernia repair.
Gilman received a 15 x 20 cm Physiomesh Composite mesh in 2016, via a laparoscopic procedure to fix a ventral abdominal hernia. Within several months she developed serious complications including the recurrence of the hernia and debilitating pain from mesh adhesions to other vital organs.
Florida Ethicon Physiomesh lawsuit claims injury
According to Gilman, “Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design.”
What is Ethicon Physiomesh?
Ethicon uses plastic or polypropylene to make the base layer of the Physiomesh. The Physiomesh is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair. Physiomesh has been on the market in the United States since 2010. The FDA approved it with a 510(k) application, which allowed it on the market without new safety studies because it was “similar” to other types of hernia mesh on the market.
Polypropylene is the same material that Ethicon used to make their transvaginal mesh and bladder slings. Ethicon is exposed to thousands of lawsuits over its polypropylene transvaginal mesh and bladder slings. Ethicon added an absorbable film coating to each side of the polypropylene to create the Physiomesh.
Alleged Complications of Hernia Mesh
- Bacterial Infection
- Chronic pain
- Hernia recurrence
- Adhesion (scar tissue)
- Intestinal blockage
- Mesh migration
- Mesh shrinkage (contraction)
- Re-do Surgery
Ethicon Physiomesh Device Voluntary Withdrawal
An Ethicon Physiomesh recall was issued by the manufacturer in several countries in 2016, due to a higher-than-expected rate of complications resulting in recurrent hernia and revision surgery.
Ethicon Inc., stopped selling all Physiomesh Flexible Composite Hernia Mesh worldwide after a large study found a possible safety risk for patients. Ethicon recalled Physiomesh in Europe and Australia, but the same action was called a “market withdrawal” in the U.S.
According to an Urgent Field Safety Notice to surgeons in May 2016, Ethicon recalled Physiomesh after analyzing unpublished data from two large independent hernia registries in Germany and Denmark. The studies showed Physiomesh had higher rates of hernia recurrence and needing another surgery compared to similar types of hernia mesh for laparoscopic ventral hernia repairs.
Ethicon blamed the complications on multiple factors, including possible “product characteristics, operative and patient factors,” but decided to remove it from the market rather than fix the issues.
The U.S. Food and Drug Administration (FDA) classified the action as a market withdrawal rather than a recall.
Massachusetts Ethicon Physiomesh lawsuit claims injury
David Watring from Massachusetts, filed a product liability lawsuit filed against Johnson & Johnson and Ethicon, over serious complications from Physiomesh used during a hernia repair caused him to suffer painful and severe health problems, including recurring hernia and the need for ongoing surgeries.
Watring had a 15×20 cm Ethicon Physiomesh patch implanted in 2013, to fix a parastomal hernia. But, by November 2013, his hernia returned, and it was discovered that the hernia contained loops of small bowel.
According to Watring, “There were several loops of small bowel contained within the hernia, with dense adhesions between the loops of the bowel. An extensive amount of time performing adhesiolysis was required in order to reduce them, as well as the adhesions between the fascial defect and the small bowel. Following this procedure, Plaintiff developed yet another hernia at the implant site of the Physiomesh and is currently awaiting consultation to determine whether further surgery is feasible.”
The Watring’s lawsuit claims the manufacturer knew that there were problems with the Physiomesh hernia repair product, but kept promoting the hernia patch to make money.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.