CR Bard Mesh Lawsuits: Hernia Mesh Complications, Composix Recall
C.R. Bard mesh implants have caused painful injuries and side effects to many people. We can help determine your eligibility to file a claim against the manufacturers responsible for putting these dangerous medical devices on the market.
In 2006 the FDA issued its first warning regarding common complications and dangerous side effects that occur with synthetic mesh implants like Ethicon Physiomesh. If you have suffered mesh erosion, adhesion, bowel perforation, or adhesion after your procedure, you may be eligible to file a lawsuit against against Ethicon, the mesh manufacturers. Call 866-829-0176 now to schedule a free consultation with Baron & Budd.
Over the last several years, many manufacturers of mesh implant devices used for transvaginal POP or SUI procedures and hernia repair surgery have been sued. Companies that manufacture surgical mesh have paid out millions and millions of dollars to settle those cases. Now new plaintiffs are coming forward, filing claims against a different type of product manufacturer: hernia mesh lawsuits. Ethicon’s flexible composite Physiomesh patch is a type of synthetic mesh associated with significantly higher rates of hernia recurrence and revision rates.
Mesh revision is a phrase used to describe mesh removal, mesh replacement, and mesh extraction because of failure or complications. The high rate of complications resulted in many Physiomesh lawsuits against Ethicon, the surgical mesh manufacturer.
Ethicon is a subsidiary of the well-known Band-Aid manufacturer, Johnson & Johnson. Ethicon manufactures and sells its brand name product, Physiomesh, for use in hernia repair operations. Physiomesh is made of polypropylene, the same product that generated thousands of lawsuits against Ethicon and other transvaginal mesh manufacturers due to its dangerous complications and side effects.
Ethicon first received Food and Drug administration (FDA) clearance to market its Physiomesh in 2010. In October 2014, the FDA gave the company clearance to market its Physiomesh Composite Mesh. The fast-track clearance was based on Ethicon’s 501(k) application which, when approved, allowed it to sell its product without rigorous testing based on its similarity to other products already on the market.
The Physiomesh Composite Mesh Patch may be similar to other products used to repair abdominal hernias, but it is not made the same as any other mesh on the market. It is made from a lighter-weight polypropylene, but gives the mesh a coating on each side. Allegations are that it makes the mesh weaker and thus prone to fall apart in the body, causing extreme pain and suffering to patients when it tears apart.
Voluntary Physiomesh Recall
Physiomesh Composite Mesh was not on the market for very long. In May 2016, Ethicon issued an “Urgent: Field Safety Notice” voluntarily recalling its Physiomesh that had been used in “laparoscopic ventral hernia repair.” The company acknowledged that the “recurrence/reoperation rates” as reported to hernia mesh registries were higher with its Physiomesh than with other mesh products.
The voluntary recall came too late for many patients who already suffered serious complications from Physiomesh Composite Mesh. Some complications related to any mesh product used in hernia repair may arise years after the mesh was implanted, so anyone who had a hernia repair using any mesh, particularly Physiomesh, needs to be aware of symptoms of complications.
Serious Physiomesh Complications
Serious complications resulting from the use of Ethicon’s Physiomesh include:
- Bowel and other organ perforation.
- Recurrence of hernia, needing subsequent additional surgery.
- Mesh erosion.
- Surgery to remove the mesh. This is not always successful.
- Hernia mesh replacement surgery.
- Seromas, which is a build-up of fluid at the surgical site.
Mesh adhesion occurs when scar tissue builds up around the mesh implant, attaching it to nearby organs or other tissue. This creates painful and dangerous attachments that can tear unexpectedly, causing organ rupture and/or internal bleeding.
There are currently three lawsuits pending in Federal Courts against Ethicon including Huff vs. Ethicon and Edwards vs. Ethicon. Experts anticipate many more in the common months and years as the same problems begin manifesting in other patients.
Some of the complications that were presented in the most recent lawsuits filed against Ethicon include:
- Immune system rejection of the foreign product.
- Improper wound healing.
- Nerve damage.
- Fistula formation.
Symptoms of Serious Complications
If you experience any of the symptoms below and have had hernia repair surgery, we urge you to seek medical attention swiftly. The symptoms below were reported by patients who have already endured complications from Physiomesh patches.
- Severe and chronic abdominal pain.
- Severe pain at the surgical site.
- Signs of infection, such as fever and malaise.
- Nodule or knot in the groin.
In its Field Safety Notice and voluntary recall letter, Ethicon claimed not to know why these complications were occurring, but acknowledged that unpublished data from two independent hernia registries were reliable enough to inspire Ethicon to recall the Physiomesh Composite Mesh.
Types of Hernias Repaired with a Physiomesh Patch
Physiomesh hernia repair patches are intended for use in ventral hernia repair procedures. Ventral hernias are abdominal hernias characterized by a bulge signaling a tear in the abdominal wall including:
- Incisional hernias.
- Inguinal hernias (groin).
- Umbilical hernias.
Abdominal hernias repaired with mesh may sometimes become incarcerated or strangulated, which can be fatal.
Physiomesh Settlements and Lawsuits
Ethicon Physiomesh problems were only recently discovered. Even so, there are already several personal injury lawsuits pending against company.
One was filed in December 2016 and alleges:
- The mesh has design defects.
- Ethicon should have known the dangers of its multi-layered polypropylene design before releasing it for public use.
- Ethicon knew or should have known about those defects, but continued to market its product.
- Ethicon failed to warn consumers about the risks of the mesh.
In addition to asking Ethicon to pay for her past, present and future medical expenses and past, present and future lost wages, the plaintiff is also asking for compensation for her pain and suffering. Additionally, she is seeking punitive damages to punish the defendant for its marketing a product it knew or should have known was defective.
Experienced Attorneys – Baron & Budd
Although lawsuits against Ethicon for Physiomesh complications are just beginning to surface, our attorneys have successfully pursued many defective mesh lawsuits against other manufacturers. Mesh cases require complex litigation skills. It’s true that there is no guarantee when taking a lawsuit to trial, having a lawyer on your side with experience can mean the difference winning or losing your case.
If any mesh was used in your hernia repair, and you are now suffering from symptoms that indicate you may be having complications related to the mesh implant, contact us at 866-829-0176 now or request an appointment online for a complimentary case evaluation. During your consultation, we will evaluate your situation and determine if your circumstances make you eligible to file a hernia mesh lawsuit for damages and compensation.
1. FDA 510(k) Approval of Ethicon Physiomesh Composite Mesh, April 9, 2010: https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf
2. Ethicon Physiomesh Composite Mesh – Field Safety Notice, Voluntary Recall. Issued May 25, 2016 : https://www.swissmedic.ch/recalllists_dl/13779/Vk_20160525_11_e1.pdf