Hernia repair surgery is one of the most common surgeries in America. There are more than a million procedures performed each year. And about 300,000 involve the use of surgical mesh implants. Roughly 70% of the market for polypropylene hernia mesh is controlled by CR Bard and its subsidiary, Davol. Many experts believe that at least 20% of these mesh implants fail.
Simple math suggests there are hundreds of thousands of patients at risk. And those numbers appear accurate. We estimate there are 42,000 mesh failures each year. The U.S. National Library of Medicine reports that incisional hernia repair involving mesh has a recurrence rate of 20-45%.
Synthetic Mesh Products Have a Long History of Failure
The history of synthetic mesh failures goes back at least two decades. A 1997 memo uncovered in one recent case involving mesh maker CR Bard said that the company was warned by its polypropylene supplier to not use the plastic compound in mesh implants.
Those warnings went unheeded.
During a New Jersey surgical mesh case, a former CR Bard vice president testified that he received a call from Chevron Phillips Chemical Company, maker of the polypropylene resin called Marlex. He testified that the resin supplier didn’t think their product should be used for medical devices. “They were concerned about litigation and the association with the Marlex name with a permanent medical implant.”
The Marlex product safety data sheet says the synthetic material should not be implanted in the human body or have permanent contact with bodily fluids or tissue.
Bard simply found other suppliers and stopped telling them how the plastic would be used.
A 2004 email reveals a CR Bard vice president saying,
“These suppliers will likely not be interested in a medical application due to product liability concerns. We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a third party, not the resin supplier, to avoid a supply issue once the medical application is discovered.”
Hernia mesh can be used in several different ways. The most common are as an overlay, an inlay or an underlay. It is easiest to remove when used as an overlay and most dangerous when used as an underlay because it comes in contact with a patient’s organs.
Bard Polypropylene Hernia Mesh Products
- Composix E/X
- Composix L/P
- Ventralex ST
- Kugel Patch
- Composix Kugel
- Ventrio ST
- Marlex (AKA Flat Mesh; Bard Mesh)
- Perfix Plug
- Perfix Light Plug
- 3D Max-Lite
- 3D Max
If you have any of the above hernia mesh products implanted in your body, you may be eligible for significant monetary damages. Keep reading to learn who qualifies and what you must do.
As of October 1, 2018, there were 15,604 total cases involving CR Bard and Davol hernia mesh. Of that number, 12,029 have been closed.
The above list of polypropylene mesh products were made by Bard and its subsidiary Davol. Although they control the lion’s share of the artificial hernia mesh market, they are not the only manufacturer. Several others are the subject of many lawsuits.
Another synthetic mesh with many reported problems is Ethicon Physiomesh. Ethicon is a subsidiary of Johnson & Johnson. The company recalled its mesh in May 2016. As of October 1, there were 1,430 cases involving Ethicon’s Physiomesh Flexible Composite mesh and an unknown number of cases related to Physiomesh Open Flexible Composite mesh.
There are 750 cases filed involving Atrium Medical Corp.’s C-Qur mesh.
Endo International was sued by approximately 30,000 people over its Perigee, Apogee, and Elevate mesh products.
Boston Scientific was sued over its Obtryx transvaginal mesh.
Closely related to hernia mesh is the mesh based pelvic repair system offered by J&J’s Ethicon. Their Pelvic Repair System has resulted in 40,290 total law suits.
Not sure what kind of mesh doctors used on you? Contact your physician or the hospital where the surgery was done. That information is listed in the doctor’s surgical notes and on the hospital chart.
What is a Hernia?
A hernia occurs when an organ, intestine or fatty tissue squeezes through a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an external bulge. They can be caused by improper lifting of heavy objects, constipation or persistent coughing.
Types of Hernias
There are several types of hernia. The most common are:
Inguinal intestine or bladder protrudes through abdominal wall
Femoral occurs in the upper thigh/outer groin, most common with obese or pregnant women
Incisional Intestinal intrusion through an old incision or scar in the abdomen (common with
Ventral occurs in the general abdominal/ventral wall
Umbilical small intestine protrusion near occurs the belly button
Hiatal occurs inside the abdomen, along the upper stomach/diaphragm
Treatment Options for Hernias
Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 of those are to repair inguinal hernias.
The only way of repairing a hernia is by surgery. Many doctors recommend frequent monitoring, however. If there are no complications and the hernia is not getting worse, it may be an option to simply leave it alone.
The most common surgical procedure is laparoscopic which requires a few tiny incisions. The surgeon inserts tools through those incisions and performs the surgery. The advantage of laparoscopic procedures is less scarring and more rapid healing. Other times surgeons will elect to do an open repair. Surgical mesh can be implanted with either procedure.
Because hernias have a high rate of recurrence, doctors will often use surgical mesh to strengthen the area in the hope of avoiding future hernias. (Want more information? Visit the FDA’s mesh information page.)
What is Surgical Mesh
Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. Most mesh is made from animal or synthetic material. Animal mesh frequently comes from pig or cow intestine and skin. The body will ultimately absorb the material, but hopefully only after the surrounding tissue has strengthened.
Synthetic mesh remains in the body forever. Like plastic that litters are landfills, polypropylene doesn’t biodegrade in the human body. It can lead to many complications, however.
Hernia Repair Surgery Complications
According to the FDA and medical literature, the most common complications for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), intestinal blockages, internal bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).
All of these complications can occur with synthetic mesh.
Many mesh products have now been recalled by the FDA. Often the recalled mesh has much higher incident rates of bowel perforation and obstruction, both of which qualify as serious side effects.
How Did Bard Mesh Products Ever Get Approved?
Believe it or not, the FDA does not test or evaluate the effectiveness of every medical device on the market. Through a procedure called the 510(k), manufacturers can obtain quick FDA approval of new products if they show it is a substantial equivalent to an existing approved product. That is how many of the hernia mesh products were approved even though they may use different coatings or types of plastic.
Hernia Mesh Injuries And Complications
There are problems with all synthetic (plastic) hernia mesh products. None of them are without side effects.
Depending on the plastic and how it is coated, some polypropylene mesh is more prone to complications.
Common side effects of polypropylene mesh include:
Infection. Mesh can become infected. Once infected, it should be removed immediately. Otherwise sepsis can develop, an often fatal complication.
Adhesion. That is another significant complication and occurs when the mesh adheres to an organ such as the bowels.
Bowel Obstruction. A common side effect of adhesion. Obstruction can also be a life threatening emergency if not immediately addressed.
Abdominal Pain. is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
Leg, Groin, and Testicular Pain. Common to inguinal hernias repaired with mesh. The pain can be excrutiating.
Pain with Sex (Dyspareunia). Caused when the mesh attaches to the spermatic cord. In extreme cases, it may require the removal of the testicles.
Diarrhea. Early symptom of the mesh attaching to the bowel.
Constipation. May be a sign of a bowel obstruction. (Seek medical attention immediately.)
Nausea. Sign of adhesions to the bowel or stomach.
Seroma. is a fluid capsule surrounding the mesh. Seromas need immediate attention as they also bring infections.
Fistula. An abnormal tunnel or passage. Often result in discharges and increased infection risks.
Dental Problems. Believe it or not, there is an increased incidence of dental problems in patients who have infections from hernia mesh implants.
Autoimmune Disorders. Again, medical evidence points to an increased number of patients who have implanted hernia mesh develop dangerous autoimmune disorders.
Neurological Changes. Several patients that have been implanted with the synthetic hernia mesh have been diagnosed with unexplained neurological changes on a CT scan.
Severe Headache. Often the sign of a much more serious problem such as sepsis or infection.
Fever. Associated with both an autoimmune response to the mesh and infection.
Renal Failure (Kidney failure). Coated synthetic meshes may interfere with kidney function.
Liver Abnormalities. Like kidneys, some liver problems have been reported by patients receiving coated synthetic mesh.
Joint Aches and Pain. Caused by inflammation due to infection and an autoimmune reaction to the mesh.
Abnormal Sweating. can be related to an autoimmune response or to an infection.
Meshoma. A tumor like body caused when artificial mesh moves, shrinks or bunches up. Although not dangerous, meshomas can be unsightly and painful.
All side effects should be treated by a physician immediately.
What is my Case Worth?
Although the hernia mesh cases are not class actions, they have been consolidated by the courts into what is called a multi-district litigation or MDL. Knowing that not every one of these cases can be tried, judges have consolidated these cases for discovery.
Several cases in the MDL have been tried. These are called bellwether cases. The defendants want only to try cases in which they know they will win while lawyers representing patients want their best cases to be tried first in order to set the damage expectations quite high.
Each case is unique, of course, so there is no average. We are presently seeing hernia mesh cases settle for between $50,000 and $100,000. Each case is different. The case value of woman who only suffers from a visible bump cause by a meshoma is much less than a case in which a patient lost his testicles or suffered from gangrene as the result of sepsis.
Johnson & Johnson lost a trial in which a Philadelphia jury awarded a woman $57 million. The woman needed three surgeries to remove the mesh and left her with permanent pain, disfigurement and inability to control her bladder. (Jury awards that size are almost always appealed which could add years to the case.)
In 2015, CR Bard settled 2,970 hernia mesh cases for an average value of $67,000.
Can I Still Sue? (Statute of Limitations)
Each state has its own statute of limitations. Some states allow you five years to sue while a couple states give you just one. The date is usually calculated from the date of the malpractice. In a hernia mesh case that would be the date of the surgery.
Complicating the matter, however, are states that have a discovery rule. That stops the clock until you knew or should have known the mesh was defective. But is that day the FDA announced a recall? Or is it the date you went to see your doctor because of pain near your old surgery site?
There are no easy answers as each jurisdiction is different. Our advice? Don’t delay another second. Call us.
Hernia Mesh Patient? Call Us Today!
If you or a loved one had surgery to repair a hernia, and suffered complications requiring surgery to remove the mesh, you may be entitled to compensation. Contact us for a free, confidential legal consultation. Even if you’re unsure which brand of mesh was used in your surgery, we may still be able to determine if you can take legal action. All services are provided on a contingent fee basis meaning you don’t pay unless we win. We can be reached online, by email or by phone 202-800-9791.