Stern Law Answers Your Questions About Surgipro™ Mesh

Stern Law’s skilled product liability attorneys are not, at this time, taking cases involving hernia repair with Surgipro™ Mesh. We provide the following as an overview of issues some have reported following implantation of Surgipro™ Mesh:

What is Surgipro™ Mesh?

A hernia occurs when internal organs, like the intestines, protrude through a weakened wall of muscle or tissue. Hernias are most common in the abdomen and groin but can develop in a variety of areas and often cause pain and discomfort. Hernias occur for a number of reasons, including heavy lifting, obesity, and strain in the abdominal area during constipation or pregnancy. The propensity for certain types of hernias can be increased by a person’s gender. For instance, it is estimated that 25 percent of men will develop an inguinal hernia in their lifetimes versus 2 percent of women.

The standard treatment for a hernia involves surgery to push the organs back into place and reinforce the weakened muscle or tissue wall to prevent recurrence. One of the products surgeons use during these operations is synthetic mesh, like Surgipro™ mesh.

Surgipro™ mesh is manufactured by Medtronic, formerly known as Covidien, and is constructed of polypropylene multifilament fibers. It comes in several sizes, depending on the hernia size and the area where the hernia is located, and can be used during open or laparoscopic hernia repair. Surgipro™ mesh is intended to be a permanent implant.

Monofilament Vs. Multifilament Mesh

Surgipro™ is a multifilament polypropylene mesh, meaning it is woven from more than one kind of polypropylene fiber, whereas monofilament mesh contains only one kind of polypropylene fiber. While use of polypropylene material for mesh implants is an issue by itself, multifilament polypropylene has been known to present a greater set of problems for patients.

When patients have polypropylene devices implanted – whether monofilament or multifilament – their bodies begin a rapid acute inflammatory response and chronic foreign body reaction. Their bodies understand that the implant is foreign and immediately begin working to isolate the foreign material from the rest of the body. This results in chronic inflammation and ongoing accumulation of scar tissue encapsulating the mesh.

In a 2007 study published in the International Journal of Immunopathology and Pharmacology (Impact of Different Texture of Polypropylene Mesh on the Inflammatory Response), researchers concluded that multifilament polypropylene mesh created a higher intense acute inflammatory response than monofilament mesh. In the study, 32 male patients underwent repair surgery for inguinal hernias. One group of patients received a monofilament polypropylene implant, and the other group received a multifilament polypropylene implant, which was Surgipro™ mesh. At the end of the study, researchers saw more intense inflammation in the patients implanted with Surgipro™ mesh.

The study also noted that other research-based evidence suggested a stronger foreign body reaction associated with multifilament mesh, along with a greater likelihood of infection following surgery. The researchers noted that there was concern about the use of multifilaments with regard to possible infection through the interstices of the braided structure, showing the increased surface area of multifilament mesh promotes the persistence of bacteria in the implant bed. The researchers stated this could explain patients having delayed diagnoses of infection.

Manufacturers try to act like the inflammation and foreign body reactions patients experience after implantation of hernia mesh are positive occurrences. Indeed, Surgipro™ mesh is designed in such a way to encourage these processes taking place. The mesh is filled with tiny holes, like a net, to allow tissue to inflame and grow into the implant. The ingrowth of tissue is supposed to create a strong barrier that keeps the herniated tissue in place and reinforces the muscle wall. Our lawyers argue this shows the defects in the Surgipro™ design.

Through time, patients continue to experience inflammation and tissue encapsulation, which leads to pain, infection, nerve damage, and a host of other injuries.

Surgipro™ Mesh Injuries

In Stern Law’s experience litigating hernia mesh claims, we have heard of numerous injuries associated with implantation Surgipro™ mesh. Most often, our clients report the following injuries:

Infection – Infection is one of the most frequent Surgipro™ mesh complications we see. Up to 8 percent of patients who have hernia repair surgery using mesh reported developing infections post operatively. The infection can be simple, requiring a round of antibiotics, or it can be severe, necessitating further surgical procedure to clean out the infection.
Chronic pain – Many patients who come to us with Surgipro™ mesh complaints report experiencing chronic pain. The pain is often localized to the site of the mesh implant, sometimes with pain radiating out to the limbs. Some of our clients report the pain is severe enough to interfere with work or other aspects of their lives.
Adhesions – Adhesions are intense buildups of scar tissue that result in tissue sticking to internal organs. Surgipro™ mesh implants tend to cause a large amount of scar tissue formation, which often leads to adhesions. Adhesions can cause pain or make any subsequent surgeries more complicated because of the need to cut through and around the thick scar tissue.
Mesh tearing – Surgipro™ mesh implants can sometimes break or tear after implantation, potentially leading to recurrence of the hernia or other bodily injury. Mesh tearing usually requires a repeat hernia repair surgery.
Mesh erosion and perforation – Surgipro™ mesh has been reported to erode into or perforate surrounding tissue and organs, causing pain, illness, and infection. In severe cases, mesh erosion or perforation requires multiple additional surgeries.
Mesh folding – Surgipro™ mesh has a tendency to fold into itself after implantation. This folding results in mesh failure and recurrence of the hernia, as well as increased risk for scar tissue formation and damage to surrounding tissue and organs.
Mesh migration – In some cases, Surgipro™ mesh will move or “migrate” to another area of the body where it is not containing the hernia and has the potential to cause other damage. Mesh migration usually requires a surgery to remove the existing mesh and repair the hernia again.
Mesh shrinkage – The polypropylene material that comprises the Surgipro™ mesh has been known to contract or shrink into itself in the months following implantation. When this occurs, the mesh can become detached from the tissue holding it in place, leaving the patient vulnerable to migration and resulting problems.
Intestinal fistula – An intestinal fistula is an abnormal hole or opening in the gastrointestinal tract that allows contents of the stomach or intestines to leak out. Hernia mesh can cause these fistulas through intense inflammation and pressure or by eroding through or perforating the intestines. These fistulas cause pain, diarrhea, nausea, dehydration, and malnutrition.
Spermatic cord injuries – In men, particularly those undergoing repair of inguinal hernias with Surgipro™ mesh, the mesh can adhere to, perforate, or entrap the spermatic cord. This leads to pain, interference in sexual function, and in severe cases, azoospermia (a total lack of sperm in ejaculate fluid), which renders men unable to have children. Some men must also undergo removal of their testicles if the spermatic cord injury is too advanced to repair safely.
Testicular ischemia – Men who have Surgipro™ mesh implanted, especially in the inguinal area, can develop a blood loss to the testicles due to the mesh cutting off regular blood flow. Some men have testicular shrinkage associated with this complication, and some men end up requiring removal of the testicles.
Bowel Obstruction – A bowel obstruction is a blockage of the large or small intestine. After surgery to repair a hernia Surgipro™ mesh, inflammation and scar tissue can build up and cause the intestine to become closed off. In addition, the mesh can adhere to the intestines, causing intestinal incarceration. Bowel obstructions impede normal digestive function by preventing stool from moving all the way through the intestines. This leads to a number of serious and painful problems. Bowel obstructions must be repaired with additional surgery.

One of the larger issues associated with all of these injuries is the near-impossibility of removing the entire Surgipro™ mesh implant once it has become embedded in a patient’s tissue. The inflammatory and foreign body reactions start immediately and can result in full tissue incorporation in one month or less. If the implant needs to be removed, doctors have the very difficult task of trying to separate the mesh from the patient’s healthy tissue. If the Surgipro™ mesh has adhered to any organs in the meantime, the doctor might be faced with removing portions of the intestines or might forego removal of the mesh because it cannot be performed safely. Many times, patients come out of a removal surgery to find out they will always have pieces of the mesh remaining in their bodies.

Reports to FDA

Manufacturers, healthcare professionals, and individual patients can submit reports of adverse events associated with drugs and medical devices to the Food and Drug Administration (FDA). The FDA has received numerous such reports regarding Surgipro™ mesh. Some of these reports include the following descriptions:

In March 2017, a patient reported having a hernia repaired using Surgipro™ mesh. Since his original surgery, he has developed severe injuries requiring three additional surgeries.
In January 2017, a patient reported having Surgipro™ mesh implanted to repair a hernia, and a later CT scan showed the mesh had adhered to her bladder. The patient underwent surgery to remove the mesh and suffered severe and permanent physical and emotion pain, including infection, organ perforation, and organ damage.
In August 2016, a patient reported undergoing surgery to repair a ventral hernia using Surgipro™ mesh. Following surgery, the patient developed severe abdominal pain and difficulty moving his bowels. A short time later, the patient collapsed and was ambulanced to a hospital where he was pronounced dead.
In June 2012, a patient reported experiencing abdominal pain for a year following hernia repair surgery using Surgipro™ mesh. In a revision surgery, the surgeon discovered the mesh had ripped away from the patient’s abdomen, shriveled up, and created lacerations in the patient’s stomach. The patient has had multiple additional surgeries and required a colostomy from her mesh injuries. She reports she is in constant extreme pain, and it is difficult for her to stand or walk without pain. She has difficulty sleeping and has developed depression.
In September 2010, a patient reported pain and infection after having a hernia repaired with Surgipro™ mesh. He required surgery to remove the mesh and infected tissue.

These are merely a few of the adverse event reports the FDA has received through the years related to Surgipro™ mesh. Despite knowing about the potential for Surgipro™ mesh to cause dangerous postoperative injuries, the FDA has remained relatively silent about the issue. The Administration has not recalled Surgipro™ mesh for safety reasons and has not issued any statements as to the safety of Surgipro™ mesh specifically.

More generally, in April 2017, the FDA issued a statement addressing all hernia mesh implants. In the statement, it reported on frequent adverse events following hernia repair with mesh and stated pain, infection, hernia recurrence, adhesion, and bowel obstruction were the most common complications associated with hernia mesh. However, at the same time, the FDA downplayed the significance of mesh in these injuries by stating that the same injuries were also associated with hernia repair surgeries that did not involve use of mesh.

The FDA went on to say it had received many reports of complications related to hernia mesh, but that it had concluded recalled mesh products were the main cause of the complications. We find this difficult to digest, given that our clients continue to report serious injuries from their hernia mesh implants, including Surgipro™ mesh, and given that these products have not been recalled.

Hernia Mesh Alternatives

The best way to treat a hernia is, unfortunately, a surgical procedure. While factors in a patient’s control, like weight and digestive health, can contribute to hernias, resolving those issues will not resolve the hernia. Even when a patient can manipulate and push the herniated tissue back in, it will always bulge out again without surgical repair. If left untreated, hernias can become more painful and can cause serious complications, like intestinal obstruction and intestinal strangulation.

Prosthetic implants, like Surgipro™ mesh, have become an extremely commonplace treatment for hernias, but they are not the only way to surgically treat hernias, and our lawyers argue they are not the safest way. To understand the alternatives, it is best to start by learning about the two different ways hernia surgeries can be performed:

Open surgery – Open surgery involves a long incision around the hernia site. The surgeon will open up the skin and fat and create a hole in the muscle down to the hernia, then push the herniated tissue back in place and reinforce the muscle/tissue wall. All types of hernias – big and small – regardless of location can be repaired using this method.
Laparoscopic surgery – Laparoscopic surgery is often regarded as a less invasive option that involves a smaller incision. The surgeon will place a balloon or gas into the body through the small incision, which will expand to create room for the surgeon to work. The surgeon will then repair the hernia using a camera and surgical tools to pull the hernia back and reinforce the muscle/tissue. Smaller hernias are usually best suited for repair using this technique.

Aside from mesh, surgeons have the option to repair hernias using sutures, and the patient’s own fascia (fibrous tissue), tendons and ligaments. They can essentially sew the muscle back together or use the patient’s own tissue, tendons, and ligaments to create a stronger wall above the herniated tissue so that it will not bulge back through.

Using the patient’s own natural body tissue prevents many of the foreign body reactions patients struggle with following mesh implantation and avoids other serious mesh complications entirely. Moreover, if the hernia reoccurs, or the patient develops another complication, the surgeon can resolve those issues without having to worry about whether he will be able to remove mesh that might have become completely encapsulated with scar tissue. This alternative provides a safer method of treatment for patients and an easier course of treatment for both patients and doctors, should complications arise.

What if I’m Unsure Whether My Surgeon Used Surgipro™ Mesh?

In any product liability case, we have to establish “proof of use” or “product identification,” meaning we have to prove with certainty that you had a specific manufacturer’s product. In the case of Surgipro™ mesh, we have to prove your surgeon implanted brand-name Surgipro™ mesh manufactured by Medtronic/Covidien. If you are not sure whether you have this specific implant, you don’t need to worry. We will help you find that information.

Many of our hernia mesh clients come to us knowing only that they have a hernia mesh implant and not knowing for sure the name of the implant. We actually expect this because we know surgeons use their time with patients to discuss the upcoming operation and postoperative recovery. They generally do not talk to patients about implant brands or manufacturers. When you hire Stern Law to investigate your hernia mesh claim, we will obtain the necessary documentation to show what implant you have.

At the outset of our investigation, we will order medical records from the day of your hernia repair surgery. We will include in our order requests for copies of intraoperative notes and implant reports. Generally, these particular records will contain a sticker or lot number from the mesh implant packaging that will tell us exactly what implant the surgeon used. Depending on what we find out, we will continue working on your claim to include your case in our Surgipro™ mesh litigation or litigation against another mesh manufacturer. There are numerous hernia mesh implants and manufacturers involved in the overall hernia mesh litigation, so it is not the end of the road if we discover you do not have a brand Surgipro™ mesh implant. We will do whatever we can to help you build a successful case.

What Can I Recover in a Surgipro™ Mesh Lawsuit?

At Stern Law, PLLC, we understand how these injuries affect your life, and we are dedicated to obtaining the compensation you deserve. When you file a claim for damages against the manufacturer of Surgipro™ mesh, you can recover for the ways you have been harmed. This includes claims for the following types of compensation:

Lost wages, if you missed work or cannot currently work because of your Surgipro™ mesh injuries;
Lost future wages, if you will not be able to return to work;
Past medical bills for treatment related to your Surgipro™ mesh injuries;
Future medical bills, if you will need additional treatment for your injuries; and
Compensation for the physical and mental pain and suffering you have incurred and will incur as a result of your Surgipro™ mesh injuries.

Your Stern Law team will analyze all your injuries, both economic and noneconomic, to make sure we capture the full extent of your damages and maximize the recovery you receive.

Stern Law Offering Free Surgipro™ Mesh Claim Review

Navigating the legal system can be difficult, especially when you have a potential claim against a large medical device corporation. But Stern Law, PLLC, made things simple for our clients with these cases. With one phone call, clients were able to start the process of deciphering whether they had a viable claim. Stern Law is no longer taking Surgipro Mesh cases.

We understand when you’re dealing with a medical device injury, you likely already have financial strain in your life from costly medical bills. That’s one of the reasons we offer consultations at no cost to you. The initial consultation is completely free, and we will investigate your claim with zero money up front. If our investigation concludes we cannot pursue a claim for you, you will never receive a bill from us.

Current Hernia Mesh Litigation

The current environment of the hernia mesh litigation is expansive because of the volume of mesh products and number of manufacturers involved. In litigations of this size, the parties will usually try to form Multidistrict Litigations (MDLs). An MDL is essentially a consolidation of cases in one federal court. Unique MDLs can be formed for each manufacturer, based on the number of lawsuits filed against that manufacturer.

The first hernia mesh MDL formed in 2007 in the U.S. District Court for the District of Rhode Island, centralizing lawsuits filed against the manufacturer Davol Inc., regarding its Kugel™ hernia mesh patches. In 2011, Davol (through its parent corporation, C.R. Bard, Inc.) settled more than 2,000 of these cases for $184 million.

Most recently, an MDL formed to centralize hernia mesh lawsuits filed against the manufacturer Atrium Medical Corp. in the U.S. District Court of New Hampshire. There is also an active application to form an MDL for hernia mesh lawsuits filed against Ethicon, Inc. Litigation of these cases is in its early stages, so no settlement negotiations have yet taken place.

Other Medtronic/Covidien Mesh Settlements

In June 2015, Medtronic came to an agreement to settle thousands of lawsuits dealing with another type of its Covidien mesh. While the settlement amount was confidential and not released, it is estimated that the settlement resolved approximately 11,300 filed and unfiled transvaginal mesh cases.

These implants were placed through the vagina to treat pelvic organ prolapse and urinary incontinence in women, and they lead to a number of dangerous side effects. Like Surgipro™ hernia mesh, Medtronic’s polypropylene transvaginal mesh caused serious complications, including pain, inflammation, infection, adhesions, perforation, erosion, and necessary additional surgeries.

Just one year before the announcement of this settlement, Medtronic acquired Covidien for $42.9 billion. At the time, Covidien had recorded a pre-tax charge of approximately $180 million for its mesh litigation in the third quarter of 2014 alone. While settlements have not been reached with Medtronic as to its hernia mesh products, we are fighting to hold the corporation equally accountable for the injuries suffered by hernia repair patients. Though different products, we believe our hernia mesh clients are just as deserving of compensation for the ways their injuries have affected their lives.

Contact Stern Law, PLLC

When you hire our firm, our legal team will build your case by undertaking the following on your behalf:

Obtaining a detailed account of your surgeries and injuries;
Ordering medical records for your original hernia operation, as well as any further treatment or surgery;
Determining product identification, or the name of your exact mesh implant, as well as the name of the manufacturer;
Consulting with medical experts and industry experts to obtain support for your claim;
Determining where your case should be filed and against whom;
Drafting and preparing a petition for filing.

Establishing all the elements for a viable hernia mesh claim takes time and significant effort, but we will put in the hard work to bring you the justice you and your family need.

If you or a loved one is suffering and needs a medical attorney, contact Stern Law, PLLC, today at (844) 808-7529. You will be able to speak to one of our experienced product liability attorneys and schedule a confidential consultation at no cost to you.