What is a Hernia?
A hernia occurs when an organ—such as the intestine—or fatty tissue moves through a weakened location in a muscle or connective tissue, according to the U.S. Food and Drug Administration (FDA). Hernias are usually seen in the abdominal wall. In some cases, a hernia is visible as an external bulge, which typically occurs when bearing down or straining.
Hernias are typically caused by both pressure and an opening or weakness of muscle or connective tissue with the pressure impelling an organ or tissue through the weakened area. Being very overweight, lifting heavy object, diarrhea or constipation, and ongoing coughing and sneezing may lead to an increase in abdominal pressure. Poor nutrition, smoking and overexertion may weaken muscles.
Surgery is the only option available to repair a hernia. Laparoscopic surgery involves a small incision in the abdomen; open repair surgery involves an incision near the hernia. Hernia mesh may or may not be used in either procedure. When sutures fail and the hernia recurs, the hernia is usually re-stitched. When mesh fails and the hernia recurs, severe complications may occur.
What is Surgical Mesh?
Surgical mesh is a medical device used to give support to weakened or damaged tissue and organs. Mounting lawsuits allege that hernia mesh does not work as intended and are associated with serious complications. The hernia mesh lawyers at Parker Waichman offer free legal consultations to individuals who suffered injuries associated with the use hernia mesh products, used for laparoscopic (minimally invasive) hernia repair.
Surgical mesh made from synthetic materials is formed into knitted or non-knitted sheets to provide permanent reinforcement. Some mesh materials include porcine (pig) skin. There are three ways in which hernia mesh may be placed. Underlay placement is tied with a greater likelihood of attaching to a patient’s underlying organs.
The larger a hernia, the likelier mesh is needed for repair and there are over 50 different hernia mesh products available. Inguinal (groin) hernias are generally smaller and are better repaired without mesh by a surgeon.
Complications of Mesh Hernia Repair Surgery
Hernia mesh may erode into a patient’s bowel, which may require multiple surgeries, long hospitalizations, partial bowel removal, and colostomies (partial removal and diversion of the colon).
Mesh failure may also lead to systemic infection, even dental infections and teeth abruptly rotting. Other adverse events include abnormal sweating; adhesion; autoimmune disorders; bowel obstruction; dyspareunia (pain during sex); fever; fistula; groin pain; hernia recurrence; infection; joint aches and pain; leg pain; liver abnormalities; mesh contraction (shrinkage); meshoma (artificial mesh migration, contracture, or bunching); mesh migration; mesh perforation; neurological changes; pain; rash; renal failure; seromas; severe headache; and testicular pain.
Hernia Mesh Injuries
Hernia mesh is used in the repair of ventral and inguinal hernias. Complications may occur depending on the part of the body in which the mesh is placed. Coated hernia mesh is likelier likely lead to injuries, including infection, when compared to on-coated hernia mesh.
Unlike sutures (stitches), which are associated few and minor potential complications, hernia mesh often leads to life-threatening complications, including eroding into the bowel. An injury that requires multiple additional surgeries, weeks of hospitalization, partial bowel removal, and colostomies. Mesh failure often causes patients to experience systemic infection that include high rates of dental infections. Many patients report that all of their teeth abruptly rotted.
A more complete list of side effects include:
- Abdominal Pain is a potential symptom of adhesion formation, bowel obstruction, infection, or nerve damage.
- Abnormal Sweating may be a symptom of an autoimmune response or an infection.
- Adhesions which connect the bowel to the hernia mesh. Adhesions often form when ventral hernias are repaired with coated mesh.
- Autoimmune Disorders have been seen in a large numbers of patients who were implanted with a pelvic or hernia mesh.
- Bowel Obstruction may be caused by adhesion formation. Symptoms include a change in bowel habits or the inability to move one’s bowels.
- Constipation may be a symptom of bowel obstruction.
- Dental Problems have been observed by medical reviewers in a large number of patients who lost their teeth following hernia mesh infection.
- Diarrhea may be an early symptom of mesh adhesion to the bowel.
- Dyspareunia (pain with sex), which is typically caused when the mesh used in an inguinal hernia repair attaches to the spermatic cord.
- Fever is often associated with an autoimmune response to the mesh and infection.
- Fistula is an abnormal tunnel between two structures. Many fistulas connect to the bowel and are tied to infections.
- Infection, including sepsis. When hernia mesh causes infection, revision surgery to remove the device is typically needed.
- Joint pain may be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
- Leg, groin, and testicular pain—often debilitating–are common in mesh-repaired inguinal hernias.
- Liver abnormalities have been documented in individuals implanted with coated hernia mesh
- Meshomas (migration, contracture, or bunching of an artificial mesh), which may become hard, tumor-like masses.
- Nausea may be a symptom of adhesion of the mesh to the bowel and stomach.
- Neurological changes have been diagnosed in patients implanted with hernia mesh.
- Rashes are often seen with hernia meshes, including the C-Qur V-Patch and Ventralex ST.
- Seroma (a fluid capsule surrounding the mesh) may occur with and without infection.
- Testicle removal may be need should the mesh erodes deep into the spermatic cord.
- Renal failure has been observed in individuals implanted with large coated meshes. The coatings are absorbable and place significant strain on the kidneys.
- Severe headache may be a sign of an infection.
FDA Mesh Injury Reports
The FDA’s review of medical adverse event reports it received revealed that recalled mesh products were the main cause of bowel perforation and obstruction complications.
Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”
Hernia mesh lawsuits continue to be filed nationwide in state and federal courts. Review of adverse events from thousands of reports have been received in which severe hernia mesh complications have led to injuries and death revealed. These reports have revealed patterns that have associated specific injuries with certain hernia mesh products. Design defects have been seen in a large number of hernia mesh products that are on the market.
Information sent to the U.S. Food and Drug Administration (FDA) and publication of major medical reviews are available concerning hernia mesh products, yet the FDA is still rapidly approving untested hernia mesh products, a practice that allegedly helps medical device makers and harms patients.
Many hernia mesh products have been found to be defective, significantly harming thousands of people nationwide, while the FDA has been slow to take action. Manufacturers of hernia mesh are aware of the life-threatening complications the mesh may cause but have been accused of not warning the public or surgeons.
To date, over 100,000 hernia mesh devices are implanted annually in the United States. In fact, many of what are considered the most dangerous hernia meshes remain on the market and have not been recalled by the FDA. Bowel obstructions and severe infections are common complications related to hernia mesh.
In April of 2016 the FDA issued an article on hernia surgical mesh implants, which indicated, in part that, “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”
Yet, one month later, Ethicon, a subsidiary of Johnson & Johnson removed its hernia mesh product, Physiomesh, over high rates of complications. The FDA’s website, as of July 2017, still has no information on the Physiomesh recall. Meanwhile, Ethicon continues to deny that Physiomesh was subject to a hernia mesh recall, but does admit it withdrew the product from the market.
In fact, to date, very few hernia mesh products have been recalled and most complaints that have been reviewed involve products that either remain on the market or have been pulled from the market, with no recalls implemented.
Some of the adverse event reports that physicians and medical device sales representatives have reported to the FDA indicate that the FDA has been made aware of a number of defects concerning specific hernia mesh devices that have allegedly led to life-changing complications. No action has yet been taking.
Polypropylene , Other Ingredients Use in Hernia Mesh
Many hernia mesh products contain polypropylene plastic. According to a Material Data Safety Sheet (MSDS) on a type of polypropylene used in some hernia mesh, indicates “Prohibited Uses: Applications involving permanent implantation into the body.
Polypropylene may lead to damage on the surface of any bodily organ it reaches. Out-of-date information and research indicated polypropylene safe for hernia repair. In some hernia mesh repairs, surgeons inserted the mesh deeper into the abdominal cavity, causing severe complications.
While polypropylene is the same material used to make many types of pelvic mesh and bladder slings, polypropylene is also used to make various non-medical devices, including fishing line and soda bottles. Polypropylene is used in the manufacture of so many commercial products because of how very inexpensive the product is. The Polypropylene Material Safety Data Sheet (MSDS) notes that “Prohibited Uses: Applications involving permanent implantation into the body.” Manufacturers of many hernia mesh products continue to use polypropylene and deny that polypropylene degrades and contracts.
Meanwhile, out-of-date literature and scientific studies revealed that polypropylene was safe for hernia repair, and only caused severe complications when used as a pelvic mesh. This information is no longer valid. Surgeons began to insert and secure hernia mesh via laparoscopic procedures; however, when a hernia is repaired with mesh in laparoscopic procedures, the mesh may be implanted deeper into the abdominal cavity, which causes the mesh to come in contact with the bowel. When polypropylene comes in direct contact with the bowels, severe complications often occur. Given the broad use of laparoscopic intraperitoneal hernia repair with mesh, the old scientific studies are no longer valid.
Specifically, manufacturers of hernia mesh products funded studies to show a lower rate of hernia recurrence when hernia mesh was used; however, the studies did not discuss the length of time that patients were monitored following mesh implantation and what were considered normal complications. Also, researchers often spoke to patients implanted with mesh 10-15 years prior who have recently suffered from mesh eroding into their bowels. Hernia recurrences and complications that occur one decade later are not captured by the research.
To gain FDA Pre-Market Approval (PMA status)—a way in which a device maker could become immune from lawsuits—manufacturers would have to conduct pre-clinical studies to prove its hernia mesh was safe. Instead, manufacturers began applying different coatings to the mesh to create a layer between the bowel and the polypropylene and are known as a composite mesh. The FDA requires barrier type medical devices such as these to undergo pre-clinical studies to ensure device safety.
Instead of conducting safety studies, the coated hernia mesh makers advised the agency that they would not promote their mesh as a barrier. Meanwhile, most mesh used in hernia repairs are untested composite meshes that have been on the market for only a few years and with no reliable data.
As intraperitoneal laparoscopic hernia repair surgeries with mesh increased, so have related, serious complications. Hernia mesh manufacturers worked to create a new hernia mesh to correct issues allegedly caused by polypropylene; however, materials other than polypropylene would require FDA Pre-Market Approval (PMA). To gain PMA status—which provides the company immunity from lawsuits—the device maker would have to conduct pre-clinical studies to prove that the hernia mesh was safe. Rather, mesh manufacturers applied various coatings to the mesh in an effort to create a layer between the bowel and the polypropylene. Most coatings are meant to be absorbed by the body over time.
Mesh with a coating is known as a composite mesh. Most manufacturers of this product promote the mesh coating as a “barrier,” instructing surgeons to use the coating as a barrier. The FDA requires any barrier type of medical device to undergo PMA and pre-clinical studies to ensure device safety. Companies simply advices the FDA that they would not promote their hernia mesh as a barrier to avoid conducting safety studies, Most mesh being used in hernia repair are untested composite mesh that have only been on the market for a few years. Also, there is no reliable data on these hernia mesh products; however, medical reviewers are noticing a very high rate of complications tied to coated hernia mesh products.
Mesh products are now one of the most profitable medical devices manufacturers make, with many making more than $100,000,000 annually. Composite mesh also sells for about 15-20 times more than uncoated polypropylene mesh. Many device manufacturers have sped to bring composite mesh on the market and many companies created and sold several different types of composite hernia mesh simultaneously; therefore, if one type of composite mesh caused too many side effects, the company would simply stop making that particular composite mesh.
Hernia Mesh Recall
Ethicon issued a recall of its Physiomesh flexible composite hernia mesh following mounting reports of increased rates of hernia recurrence and reoperation when compared to other mesh devices.
Ethicon advised healthcare providers in a May 25, 2016 “Urgent Field Safety Notice.” Unpublished data from two large independent hernia registries—Denmark and Germany—revealed that Ethicon Physiomesh Flexible Composite Mesh was tied to higher hernia recurrence and reoperation rates when compared to the average rates of other mesh devices. Ethicon’s Physiomesh contains polypropylene in its base layer.
Ethicon was unable to isolate what caused the increased Physiomesh reoperation rates and announced that, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors….
Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market…. Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
Hernia Mesh Lawsuits
As of March 2017, a total of 24 cases were filed against Atrium Medical Corp. over its C-Qur mesh in multidistrict litigation (MDL) being heard in the U.S. District Court for New Hampshire. Plaintiffs similarly allege that defects in the C-Qur mesh products cause an allergic or inflammatory response that leads to severe complications, among other allegations.
Also, numerous surgeons and hospitals have stopped using the C-QUR mesh due to mounting reports of infection rates, bowel obstructions, and allergic reactions to its fish oil coating.
In December 2016 a lawsuit brought against Johnson & Johnson and Ethicon was filed in the U.S. District Court for the Middle District of Florida and includes allegations of severe complications following Ethicon Physiomesh hernia surgery, that the plastic mesh adhered to other vital organs, that the Physiomesh was defectively designed and unreasonably dangerous for use in hernia repair, and that the risks of the mesh’s design outweighed its potential benefits.
Another lawsuit, filed against device maker, Atrium, included allegations that Atrium was negligent and hid the dangers of its C-Qur mesh. In this case, a pathology report indicated that a “foreign body giant cell reaction” occurred in the patient’s body, including scarring of the tissue around the mesh implant.
Hernia Mesh Injury Reports
There are many different hernia mesh products available that are manufactured by different medical device companies. Following are some hernia mesh devices that have been the focus of a large number of complaints.
Johnson & Johnson’s Subsidary, Ethicon:
- Proceed Hernia MesH
- Prolene Hernia System
Covidien – Medtronic
- Parietex Composite Mesh
- Parietex ProGrip / Parietex Plug and Patch System
Atrium – Maquet – Getinge Group
- C-Qur Hernia Mesh
Davol – C.R. Bard
- Kugel Hernia Mesh
- PerFix Plug
- Ventralex ST Hernia Mesh (Sepramesh)
Filing a Drug or Medical Device Injury Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing a personal injury lawsuit over injuries involving a defective medical device, contact one of our experienced lawyers today. Our firm offers free, no-obligation case evaluations.
For more information, call 1-800-YOURLAWYER (1-800-968-7529).
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