The Hollis Law Firm has filed several hernia mesh lawsuits and is now investigating all hernia mesh claims. While working on the pelvic mesh and bladder sling litigations, our mesh attorneys received frequent calls from victims around the country reporting severe hernia mesh complications. Patterns began to appear, linking specific injuries with certain hernia mesh products. The Hollis Law Firm decided to launch an investigation into various hernia mesh products. Our hernia mesh attorneys have now uncovered design defects in a large number of hernia mesh products currently on the market.
Over the course of our investigation, our hernia mesh attorneys have gathered a large amount of information and scientific studies on hernia mesh. The Hollis Law Firm has created this webpage in an attempt to educate the public on the dangers of hernia mesh. Below you will find short summaries of many of the hernia mesh products we are currently investigating. At the end of each summary is a link to more information and the scientific studies associated with the specific hernia mesh lawsuit. A brief, general summary for each hernia mesh study is provided. Links to the full study are also provided for further research; however, due to copyright laws, often only the abstract of the study is available publicly.
Why Learning About Hernia Mesh is Important
The FDA continues to quickly approve untested hernia mesh products, which benefits the medical device manufacturers and hurts the general public. When a product is then shown to be defective, severely injuring thousands nationwide, the FDA is slow to take any action. The manufacturers of hernia mesh know of the life-threatening complications their products can cause, but they don’t warn the public or surgeons. Educate yourself on the dangers of hernia mesh and warn those you know.
There are over 100,000 hernia meshes implanted every year in the United States. Many of 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.
What is the FDA’s Opinion on Hernia Mesh?
In April of 2016 the FDA put out an article on hernia surgical mesh implants. The following excerpt demonstrates just how out of touch the FDA is with how dangerous current hernia mesh products are.
“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.”
Just one month later, the manufacturer of the Physiomesh, Ethicon a subsidiary of Johnson and Johnson, removed the hernia mesh due to high rates of complications. Currently, the FDA’s website still has no information on the Physiomesh recall. Ethicon continues to deny that the Physiomesh was subject to a hernia mesh recall, but does admit that they withdrew the product from the market. To date, there have been very few hernia mesh products actually recalled. The majority of complaints that our hernia mesh lawyers receive are on products that have not yet been recalled, or have simply been “pulled from the market.”
Is the FDA Turning a Blind Eye to the Complications Caused by Defective Hernia Meshes?
It seems like an outrageous proposition, until you read some of the adverse event reports that physicians and medical device sales representatives have reported to the FDA. Repeatedly, the FDA has been alerted to various defects related to specific hernia meshes that are resulting in life-changing complications, yet no action has been taken. To highlight how absurd it is that the FDA hasn’t taken action on various hernia mesh products, the Hollis Law Firm created a Parietex ProGrip lawsuit page and a Parietex Composite lawsuit page. Both pages highlight FDA adverse event reports that should have made it obvious to the FDA why patients were experiencing specific complications with certain hernia mesh products. Shortly after the two pages went live, the FDA’s entire online adverse event database went down. We’re just getting started though. Now that the FDA’s online adverse event database is back up, we will be making similar updates to every hernia mesh subpage
Why Does Hernia Mesh Cause So Many Complications?
What causes the complications can vary depending on the hernia mesh product. Many hernia mesh products contain a type of plastic known as polypropylene, the same material that is used to make many types of pelvic mesh and bladder slings. Polypropylene is also used to make a wide variety of non-medical devices, such as fishing line and soda bottles. Polypropylene is utilized to make so many commercial products for one main reason, it’s dirt cheap. Here is a Polypropylene Material Safety Data Sheet (MSDS) for a type of polypropylene used in many hernia mesh products. The MSDS notes “Prohibited Uses: Applications involving permanent implantation into the body.” However, the manufacturers of many hernia mesh products continue to use polypropylene and deny that polypropylene degrades and contracts.
Should Hernia Mesh Ever Be Used?
Yes, there are times when mesh needs to be utilized to repair a hernia. The larger a hernia is, the more likely a mesh is needed. If a mesh is required to repair the hernia, there are more than 50 different hernia mesh products to choose from. Various manufacturers utilize a wide range of materials to make their hernia meshes. These materials range from plastics to gels to pig skins. Later in this article, we will cover some of the most dangerous types of hernia mesh. Additionally, certain hernias are easier to fix without using mesh. Inguinal hernias are typically smaller and can be repaired without mesh by a skilled surgeon. The unnecessary use of hernia mesh to repair inguinal hernias has resulted in thousands of patients developing debilitating pain.
Alternatives to Hernia Mesh
- Shouldice Repair: A two layer suture only hernia repair utilizing the patient’s fascia and tendon.
- McVay Repair: Abdominal tendons are sutured to the inguinal ligament.
- Bassini Repair: A suture inguinal hernia repair that preserves the spermatic cord.
- Desarda Repair: A suture only repair using multiple layers of fascia.
Long before hernia mesh was utilized to repair hernias, surgeons used the shouldice technique to repair hernias. The shouldice technique originated from the Shouldice Hospital in Ontario, Canada, where the technique is still favored to this day. For over 70 years, the Shouldice Hospital has maintained a success rate of 99.5% on primary inguinal hernia repairs. In most cases, general anesthesia is not even necessary to perform the shouldice repair. Typically local anesthetics, pain medication, sutures and a sedative is all that is required. Not having to rely on general anesthesia greatly reduces the risk associated with any surgery. It is time for the surgeons in the United States to start learning the Shouldice technique again while in residency.
When Should Hernia Mesh Never Be Used?
Smaller hernias, such as hernias caused by laparoscopic surgery, don’t require mesh to repair. Small hernias can easily be repaired with sutures by an experienced surgeon. The difficulty with hernias is they are very difficult to permanently repair. There is a high rate of hernia recurrence, both with sutures and with mesh. When sutures fail and the hernia comes back, the surgeon can usually try to stitch the hernia back up. When a mesh fails and the hernia comes back, many severe complications can occur. Also, the hernia is usually much larger after mesh failure. Abdominal tissue and muscle typically adheres to the mesh and must be removed with it.
Types of Hernias
- Incisional: At an old surgical incision.
- Umbilical: Near the belly button.
- Inguinal: Groin.
- Femoral: High in the thigh.
- Recurrent: Previous hernia site.
- Bilateral: Both left and right sides
How do the Manufacturers Convince Surgeons to Use Hernia Mesh?
The manufacturers of hernia mesh products funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was utilized. These studies were lacking in many ways, such as the length of time that patients were monitored after mesh implantation and what were considered “normal complications.” Our hernia mesh attorneys frequently talk to victims that were implanted with mesh 10 or 15 years ago and have just recently suffered from the mesh eroding into their bowels. Hernia recurrences and complications that happen 10 years later aren’t captured by the studies.
How Bad are Hernia Mesh Complications?
Unlike sutures, which have relatively few and minor possible complications, hernia mesh frequently causes life-threatening complications. Hernia mesh can erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. The mesh failure frequently causes patients to experience a systemic infection. Our hernia mesh lawyers have also recently observed high rates of dental infections associated with mesh failure. Many victims report all of their teeth suddenly rotting out. Even if there is a slightly lower rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.
Hernia Mesh Injuries and Complications
Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The following is a list of the array of complications our hernia mesh lawyers have observed:
- Infection, including sepsis. An infected hernia mesh almost always requires removal.
- Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
- Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
- Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
- Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
- Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
- Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
- Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
- Diarrhea can be an early symptom of the mesh attaching to the bowel.
- Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
- Nausea can be an additional sign of adhesions to the bowel and stomach.
- Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
- Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
- Dental Problems. Our lawyers have observed a large number of clients who have lost their teeth after a hernia mesh infection.
- Autoimmune Disorders. An alarming number of our clients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
- Neurological Changes. Several of our clients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
- Severe Headache. Typically a sign of a larger problem, such as an infection.
- Fever. Associated with both an autoimmune response to the mesh and infection.
- Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
- Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
- Joint Aches and Pain can be caused by increased systemic 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 is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.
Too Many Lawyers and Surgeons Rely on Out of Date Hernia Mesh Studies
Polypropylene can cause damage to the surface of any organ it is touching. Old literature and scientific studies found that polypropylene was safe for hernia repair, and only caused severe complications when used as a pelvic mesh. This is why most attorneys have, and still refuse to take hernia mesh cases. The old literature and scientific studies are no longer valid though. Over time, surgeons began to insert and secure hernia mesh via laparoscopic procedures. When a hernia is repaired with mesh laparoscopically, some surgeons insert the mesh 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 typically arise. Due to the now widespread utilization of laparoscopic intraperitoneal hernia repair with mesh, the old scientific studies are no longer valid.
Why Do So Many Hernia Mesh Products Have Coatings Now?
As intraperitoneal laparoscopic hernia repair surgeries with mesh increased, so did the severe complications. The hernia mesh manufacturers scrambled to create a new hernia mesh that would fix the problem polypropylene was causing. However, any material other than polypropylene would have to undergo FDA Pre-Market Approval (PMA). In order to gain PMA status (which also makes the company immune from lawsuits), the company would have to conduct pre-clinical studies to prove that the hernia mesh was safe. Instead, the manufacturers began to apply various types of coatings to the mesh. The idea was that the coating would create a layer between the bowel and the polypropylene. Most of these coatings are intended to be absorbed by the body over a period of months to years.
Differences in Mesh Placement
- Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
- Inlay– The hernia mesh is placed between layers of the rectus abdominis.
- Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position.
Composite Mesh: The Most Dangerous Type of Hernia Mesh
Any mesh with a coating is known as a composite mesh. Most of the manufacturers promote the meshes coating as a “barrier” and instruct surgeons to use the coating as a barrier. The FDA requires any “barrier” type of medical device to undergo Pre-Market Approval and pre-clinical studies to ensure the device’s safety. Instead of conducting safety studies, companies just told the FDA that they wouldn’t promote their hernia mesh as a “barrier.” A majority of the meshes currently being used in hernia repair are untested composite meshes that have only been on the market for a few years. There is currently no reliable data on these hernia mesh products. Our hernia mesh attorneys are currently noticing a very high rate of complications associated with hernia meshes that are coated.
Big Profits Making Composite Mesh
Due to the complications that polypropylene was causing when it came in direct contact with the bowel, the demand for composite hernia mesh skyrocketed. Any company with a composite mesh could rapidly increase its nationwide market share. Mesh products were already one of the most profitable medical devices a company could manufacture, many making over $100,000,000 a year! A composite mesh also sells for approximately 15 – 20 times more than an uncoated polypropylene mesh. Suddenly, every device manufacturer rushed to get a composite mesh on the market. Many companies created and sold several different types of composite hernia mesh at the same time. If one type of composite mesh caused too many side effects, the company would simply quit manufacturing that particular composite mesh. There are currently over 350,000 hernia repairs in the United States each year.
Current Hernia Mesh Lawsuits and Investigations
There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products that our hernia mesh lawyers receive a large number of complaints about. Bookmark this page and check back soon, this list is growing and we continue to add more unique content every week!
ST hernia mesh is Bard’s resorbable coated hernia mesh line. Bard acquired the licensing rights to the Sepramesh and Sepra Technology (ST) coating from Genzyme in December of 2007. Bard then expanded its coated hernia mesh product line by utilizing the ST coating to produce the Ventralight ST, Ventralex ST, and Ventrio ST. As with all coated hernia meshes, our attorneys see high rates of dense adhesions, bowel obstructions, bowel resections, seromas, and infections associated with the entire ST product line. The Hollis Law Firm is currently reviewing claims on all of Bard’s ST polypropylene hernia mesh product line. Learn more about how the Ventrio ST and Ventralex ST evolved from the original Kugel and Modified Kugel here at our Bard ST Hernia Mesh Lawsuit page. Don’t miss this new hernia mesh page!
The Composix Kugel hernia mesh was one of first and most well known hernia meshes to be recalled. C.R. Bard recalled several lots of the Composix Kugel hernia patch in 2005, 2006 and 2007. The Composix Kugel hernia mesh patch has a ring in the middle of the mesh to help it keep it’s shape. Multiple lots of the Composix Kugel hernia mesh were recalled due to a large number of reported ring breaks. Many patients have suffered bowel perforations as a result of the inner ring of the Composix Kugel hernia patch breaking. Davol only recalled limited lots of the Compoxix Kugel, claiming that certain lots had defective rings. The Composix Kugel is made with a polypropylene base and a layer of ePTFE, resulting in a material mismatch. As the ePTFe and polypropylene shrink at different speeds, the Composix Kugel can deform and the ring can break. For more information on the Composix Kugel hernia patch, please visit our Composix Kugel hernia patch lawsuit page.
The 3DMax is a bare heavy-weight polypropylene mesh used to treat inguinal hernias. In 2008, Bard released a light-weight version of the 3DMax called the 3DMax light. Patients nationwide have experienced severe, debilitating pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can erode through soft tissue and then attach to the spermatic cord in men, causing severe sexual dysfunction and testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh. The 3DMax is curved, and is intended to be implanted without any sutures or tacks. Our hernia mesh attorneys have identified many cases where the Bard 3DMax has folded over upon itself and migrated inside the patient. As can be seen in the picture, the outer sealed edge of the 3DMax also has a tendency to easily break and tear. The sealed edge is intended to help the 3DMax maintain its shape. Bard’s 3DMax simply is not fit for permanent, life-long human implantation. Learn more at our Bard 3DMax Lawsuit page.
The PerFix Plug is a bare polypropylene mesh used to treat inguinal hernias. The PerFix Plug looks like a shuttlecock. The PerFix Plug also includes an option polypropylene onlay patch. Bard began marketing the PerFix Plug in 1992. After selling the PerFix Plug for 17 years, Bard finally asked the FDA for 510(k) clearance regarding the PerFix Plug. The PerFix Plug frequently erodes and migrates throughout the patient. Injuries associated with the PerFix Plug can take years to decades to manifest and include mesh migration resulting in organ perforation and severe pain, due to the cone tip of the plug acting as a pivot and bearing the greatest pressure. The PerFix Plug became one of the most frequently implanted hernia meshes in the world, with more than 5 million implants worldwide.The PerFix Plug is another hernia mesh that has caused many men to loose a testicle. The PerFix Plug is not necessary to repair an inguinal hernia. Learn more at our Bard PerFix Plug Lawsuit page.
Ethicon- Johnson & Johnson
The Proceed hernia mesh came to market in 2003. The Proceed is a light-weight hernia mesh with an Oxidized Regenerated Cellulose (ORC) fabric covering the polypropylene. The cellulose is adhered to the polypropylene with polydioxanone (PDS). Ethicon touts the Proceed’s barrier as supporting “safe and comfortable healing.” Ethicon has previously issued limited recalls on the Proceed hernia mesh, because of the cellulose layer separating from the polypropylene and increasing the risk of bowel complications. The Proceed hernia mesh continues to delaminate and should be permanently recalled. Physicians have submitted 100’s of adverse event reports to the FDA and Johnson & Johnson regarding the Proceed hernia mesh being defective and injuring patients. For more information on Proceed and to see the adverse event reports yourself, please visit our Proceed Lawsuit page.
The Physiomesh was withdrawn from the market in May of 2016. Ethicon maintains that they did not recall the Physiomesh. The Physiomesh was a composite hernia mesh. Multiple studies revealed that Ethicon’s Physiomesh had high rates of complications, including subsequent hernias and additional surgeries. Ethicon admitted that they’re unable to determine why the Physiomesh is defective, or how to decrease complications for those who had a Physiomesh implanted. Part of the problem was likely that the Physiomesh had a coating on each side of the mesh. The coating prevented the Physiomesh from properly incorporating with the host tissue. Prior to removing (not recalling) the Physiomesh from the market, Ethicon created a new hernia mesh called Physiomesh Open. For more please visit our Ethicon Physiomesh Lawsuit page.
The Prolene Hernia System (PHS) was introduced to the market in 1997. The Prolene Hernia System is similar to polypropylene mesh plugs with a polypropylene onlay. In fact, the Prolene Hernia System cites Bard’s Perfix plug as a predicate device. Our hernia mesh lawyers have observed similar complications associated with the Prolene Hernia System and the Perfix plug. The Prolene Hernia System utilizes heavy-weight polypropylene. In 2007, Ethicon came out with the Ultrapro Hernia System, a light-weight version of the Prolene Hernia System. Light-weight polypropylene was believed to cause less complications than heavy-weight polypropylene. Injuries associated with the PHS include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal. As more information becomes available we will update our Prolene Hernia System Lawsuit page.
Atrium – Maquet – Getinge Group
The C-Qur is a composite hernia mesh that came to market in 2006, and was initially marketed by Atrium Medical Corporation. Maquet, a subsidiary of the Getinge Group, acquired Atrium in 2011 and now manufactures the C-Qur hernia mesh. The FDA has issued several warnings letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Qur hernia mesh itself.
The C-Qur hernia mesh has an Omega-3 Fatty Acid coating that causes severe allergic reactions. The C-Qur hernia mesh is also associated with life-threatening systemic infections. Removing the C-Qur mesh is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount. Our hernia mesh recall lawyers continue to receive frequent complaints related to the C-Qur hernia mesh. For more information, please visit our Atrium C-Qur Hernia Mesh Lawsuit page.
The ProLoop is a polypropylene plug mesh intended for inguinal hernia repair. The ProLoop came to market around the early 2000’s. The exact date is unclear though, because there isn’t a 510(k) available on the FDA’s website for the ProLoop during this time frame. Atrium cribbed off of Bard’s PerFix Plug when designing the ProLoop. Like Bard’s PerFix Plug, the attorneys at the Hollis Law Firm believe that Atrium utilizes non-medical grade polypropylene to make the ProLoop. While the PerFix Plug looks shuttlecock, the ProLoop resembles a wad of fishing line. The ProLoop is manufactured under the same unsanitary conditions as Atrium’s C-Qur mesh. Our hernia mesh attorneys also believe that Atrium utilizes non-medical grade polypropylene to create the ProLoop. Chronic pain, high recurrence rates, and infections have been associated with Atrium’s ProLoop. The ProLoop has never been recalled and remains on the market. For more information, please visit our Atrium ProLoop Hernia Mesh Lawsuit page.
Covidien – Medtronic
The Parietex hernia mesh was Covidien’s first polyester hernia mesh. The Parietex originally came to the market in 1999 as a heavy-weight polyester mesh. The original Parietex caused many problems similar to polypropylene based hernia meshes, such as adhesions, infections, and bowel complications. Like polypropylene, polyester also shrinks and contracts to a significant degree after it is implanted in the body. As the Parietex contracts, tension increases and the mesh has a tendency to tear where the tacks or sutures were used to secure it. Severe pain and a recurrence of the hernia typically result when the Parietex mesh rips apart. After the Parietex detaches it can migrate to other parts of the body. For more information visit our Parietex Lawsuit page.
The Parietex Composite (PCO) mesh is composed of a polyester base with a resorbable collagen barrier. The resorbable collagen barrier is intended to prevent the polyester base from adhering to the patient’s bowel. Covidien touts the Parietex as a unique material that “works with the body’s natural systems.” However, many of our clients would disagree. The collagen layer of the Parietex Composite hernia mesh is very thin and delicate. The collagen layer disappears quickly after implantation and does little to nothing to protect the bowel and underlying organs from the polyester base. Recently, Covidien came out with the Parietex Optimized Composite Mesh in an attempt to fix the problems associated with the collagen layer. The hernia mesh lawyers at the Hollis Law Firm frequently see severe adhesions, bowel obstructions, and infections associated with the Parietex Composite hernia mesh. Additionally, like the original Parietex, the Parietex Composite tears easily on sutures or tacks as it begins to contract post implantation. Learn more at our Parietex Composite Lawsuit page.
The Parietex ProGrip and the Parietex Plug and Patch System are made from polyester weaved together with a partially semi-resorbable polylactic acid (PLA) layer. The Parietex ProGrip is a “self-fixating” mesh because it has thousands of hooks that are intended to keep the mesh in place. However, the thousands of hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove. When the Parietex ProGrip fails and complications result, multiple surgeries are usually required to remove the underlying problem: the defective Parietex ProGrip hernia mesh. Covidien was recently acquired by Medtronic for nearly $50 billion. Covidien is also one of many defendant mesh manufacturers in the pelvic mesh litigation. Learn more at our Parietex ProGrip Lawsuit page.
Gore’s DualMesh came to the market in 1995, and is rarely used today. However, victims nationwide continue to be injured by latent infections due to Gore’s DualMesh. Unlike the above hernia meshes, the DualMesh is made entirely out of expanded polytetrafluoroethylene (ePTFE). Once the DualMesh becomes infected, the ePTFE begins to degrade. As the DualMesh degrades, pockets form in the ePTFE which are ideal for bacteria to thrive. Infections related to the DualMesh typically require numerous surgeries to remove the failed DualMesh and clear the infection. Learn more at our DualMesh Lawsuit page.
Scientific Articles on Hernia Mesh
The below articles are on hernia mesh in general. Each hernia mesh subpage also contains additional case specific scientific articles.
The authors explain that “mesh-related visceral complications are hardly considered, although they have much more significant adverse effects on the patient, when compared with common complications following abdominal hernia repair, and they require a challenging surgery in the majority of cases.” The authors note that “mesh manufacturers claim their meshes are visceral compatible, mostly on the basis of the results of animal studies, but it is not true. No material is inert, even the supposed viscera-friendly meshes.” The authors opine that “tissue reactions occur as a result of a chemical process related to the degradation of coated meshes.”
The studies objective was to assess the role of registries in the postmarketing surveillance of surgical meshes, because surgical meshes do not require premarket clearance by clinical studies. The authors concluded that “registries tend to be more suitable for long-term evaluation of surgical meshes for all patients operated on with this medical device… therefore, based on the new marketing authorization procedures, before surgical meshes are first placed on the market in the future, it is likely that [randomized controlled trials] will be carried out, whereas registry studies will be used to collect clinical data for postmarketing surveillance of surgical meshes.”
The authors investigated how hernia meshes change once they have been implanted. The authors note that “oxidative stress at the site of implantation causes polymeric implants to lose their structural and mechanical integrity; crystallinity and molecular weight may also change. This can result in the mechanical stiffening and/or shrinkage of the mesh, which may ultimately lead to the development of postoperative chronic pain.” The authors conclude that their “results are also in agreement with those obtained for the explanted PP hernia repair meshes that also demonstrated cracks, extrusion lines and holes on the surface.”
632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.
36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.
The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”
164 explanted polypropylene meshes were reviewed. 162 of the explants exhibited signs of degradation. The only two hernia meshes to not exhibit signs of degradation had only been implanted for 3 and 10 months. The authors note that “polypropylene degradation is likely mediated by the foreign body reaction, which is ongoing until the device is removed. Our observations of adherent macrophages on the polypropylene surface are consistent with the previous studies reporting chronic inflammation in explanted polypropylene mesh several years after implantation.” The authors also explain the clinical importance “of degradation is the potential for bacterial colonization of the fissures within the degraded material. It is known that irregularities of polymer surface promote bacterial adherence.”
768 patients underwent hernia repair. 10% experienced a hernia mesh infection. 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.
637 hernia mesh repairs and 1145 suture repairs were compared. Hernia mesh repair was associated with a slightly lower rate of recurrence, but a higher rate of severe complications. The authors admit that “further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”
Uncoated polypropylene was compared to various types of coated polypropylene placed intraperitonally via laparoscopic procedure. The uncoated polypropylene hernia mesh resulted in significantly more adhesions.
The study notes that “In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation.” The authors advise additional research is necessary, and to be wary of short-term experimental results on laparoscopically placed hernia mesh.
The authors are concerned about using polypropylene mesh (PPM) for laparoscopic hernia repair. They question if paying 15-20 times more for a composite mesh is worth it. The study notes “Complications of intraperitoneal PPM (adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence) can occur with the newer mesh also. There is no statistically significant difference in the incidence of these complications between these meshes.”
The author concludes that polypropylene “alters in vivo after implantation. It undergoes various processes that lead to degradation, including oxidation, cross-linking, depolymerization and embrittlement. These processes result in various degrees of degradation, and the loss of mechanical and physical properties. PP mesh is not inert.”
The study notes that polypropylene “is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
The surgeons note experiencing serious complications in several patients implanted with a composite mesh. Injuries included small bowel resections and mesh removal. The study notes “We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature. No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found.”
The study discusses the need for a better identification, classification and reporting systems for hernia mesh infections. It notes part of the difficulty is that hernia mesh implants have a tendency to remain dormant for long periods of time. It can take years before a hernia mesh infection is identified.
January 2010: Oral Biofilms: Emerging Concepts in Microbial Ecology.
The overall health and biology of an individual is closely linked to which oral biofilms develop.
Laparoscopic hernia repair requires expanding the abdomen with approximately 3 liters of gas. The surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.
How Does the FDA Learn About Hernia Mesh Complications?
If a hernia mesh fails within a few years and the same surgeon that implanted the mesh removes the mesh, the surgeon will sometimes report the complication to the manufacturer. It is then the manufacturers duty to determine if the complication warrants notifying the FDA. Through our investigations, our hernia mesh lawyers have uncovered that many manufacturers fail to report adverse events related to hernia mesh to the FDA. Surgeons will also occasionally file adverse event reports directly to the FDA, but the process is very time consuming. As a result, the FDA is only aware of a very small percentage of total hernia mesh complications. The manufacturers of hernia mesh then cite to low rates of hernia mesh complications reported to the FDA as evidence that hernia mesh is safe!
Are There Other Ways to Report Hernia Mesh Complications to the FDA?
If you have suffered hernia mesh complications, you can alert the FDA through a MedWatch Report. You can also alert the FDA by filing a hernia mesh lawsuit against the manufacturer of the mesh. When a manufacturer is notified of a pending hernia mesh lawsuit, the manufacturer must report the basis of the hernia mesh lawsuit to the FDA. Medical device companies are allowed too much discretion on if they have to notify the FDA when a surgeon reports a hernia mesh adverse event. The medical device companies do not have discretion on reporting a hernia mesh lawsuit to the FDA. The companies must report every single hernia mesh lawsuit to the FDA.
Hernia Mesh Lawsuit
Please call 1-800-701-3672 to speak to one of our trained hernia mesh team members. An attorney and a medical professional will look over your hernia mesh case and let you know what they believe the best course of action is for you. The Hollis Law Firm does not handle class actions. Each claim is an individual hernia mesh lawsuit. The specific facts of your case will determine if your hernia mesh lawsuit is compensable and to what amount. The Hollis Law Firm represents hernia mesh victims nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call 1-800-701-3672 for a hernia mesh lawsuit evaluation. Follow our Hernia Mesh Lawyer FaceBook page to stay up-to-date on the latest hernia mesh litigation updates.
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