The experienced product liability attorneys at Stern Law, PLLC, are taking cases involving hernia repair with the PerFix™ Plug. If you had surgery to repair a hernia using the PerFix™ Plug and developed a complication, contact our offices today to see if you might be eligible to file a claim against the manufacturer.
Hernia Causes and Treatment
A hernia occurs when internal organs or tissue protrude through a weakened wall of muscle or tissue. Hernias are associated with weakened muscles because of a preexisting muscle condition, aging, or continual strain on the abdomen or groin. This strain can occur during lifting heavy objects, chronic coughing, enduring pregnancy and child birth, being overweight, or straining because of constipation. Hernias are most common in the abdomen and groin but can also develop in other areas of the body. They often cause pain and discomfort, in addition to creating a visible bulge on the patient’s body.
The most commonly known hernias are:
- Umbilical hernias (occurring near the belly button)
- Ventral hernias (occurring in the abdominal wall)
- Inguinal hernias (occurring in the groin area)
- Femoral hernias (occurring in the inner thigh area)
- Hiatal hernias (occurring in the chest and diaphragm area)
- Epigastric hernias (occurring between the chest and belly button)
- Incisional hernias (occurring at the site of a previous surgical incision)
Some factors above, like weight and digestive health, can contribute to hernias, but changing those behaviors will not treat a hernia. Unfortunately, the only way to effectively treat a hernia is surgery. While the herniated tissue can sometimes be manually manipulated and pushed back in, it will always come back out without surgical repair.
Hernia repair surgery can occur in one of two ways:
- 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 involving 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. This technique is usually best suited for smaller hernias.
Surgeons will often use mesh implants during these surgeries to try to contain the hernia and build a stronger muscle wall. One of these mesh implants is the PerFix™ Plug.
PerFix™ Plug Product Information
The PerFix™ Plug is a piece of mesh constructed of polypropylene monofilaments. Polypropylene is a thermoplastic polymer that, when strung into fibers, can be woven together to form a porous sheet of material (mesh). Davol, which is a subsidiary of C.R. Bard, Inc., manufactures the PerFix™ Plug for repair of hernias in the groin area of the body.
Resembling a flower, the PerFix™ Plug is inserted by its inner “petals” through a small, 4 to 5 cm incision near the hernia site. The plug fills in the hernia defect, and then an “onlay,” or flat sheet of mesh material, is fixed over the top of the plug to reinforce the weakened wall of tissue around the hernia. An entire hernia operation using the PerFix™ Plug can take 25 minutes or less to complete.
Reported Injuries from the PerFix™ Plug
In our practice at Stern Law, we have heard clients report numerous injuries from hernia repair surgery using the PerFix™ Plug. These injuries range in severity, with the most common of those being:
- Chronic pain – Ongoing postoperative pain is one of the most common complaints we have heard from our clients. Many report pain that radiates to their limbs and interferes with numerous aspects of their lives.
- Infection – Infection is also a common PerFix™ Plug complication. Nearly 8 percent of patients who have hernia repair surgery using mesh reported developing infections postoperatively.
- Adhesions – Adhesions are large formations of scar tissue that result in tissue sticking to internal organs. Implantation of the PerFix™ Plug can trigger scar tissue formation, which often leads to adhesions.
- Mesh erosion – The PerFix™ Plug has been reported to erode into surrounding tissue and organs, causing pain, illness, and infection. Men are especially at risk of erosion into the spermatic cord following hernia repair with a PerFix™ Plug because of its proximity to the typical site of this mesh implantation.
- Mesh migration – Many clients report the PerFix™ Plug changed positions after surgery, or “migrated” to another area of the body. Mesh migration usually requires a surgery to remove the existing mesh and repair the hernia again.
- Mesh shrinkage – The PerFix™ Plug polypropylene can contract or shrink into itself after surgery, which can cause the mesh to become detached from the tissue holding it in place. This can result in hernia recurrence, migration, or other complications.
- Intestinal fistula – Hernia mesh like PerFix™ Plug can cause intestinal fistulas (an abnormal hole or opening in the gastrointestinal tract) through intense inflammation and pressure on the intestines. These fistulas can also be caused by mesh erosion through or perforation of the intestines. These fistulas cause pain, diarrhea, nausea, dehydration, and malnutrition. They must be addressed through additional surgery.
- Spermatic cord injuries – Men undergoing repair of inguinal hernias with PerFix™ Plug can develop injuries to their spermatic cord due to the mesh adhering to, perforating, or entrapping the spermatic cord. This leads to pain, interference in sexual function, and in severe cases, a complete absence of sperm in their ejaculate fluid. The loss of sperm leaves these men unable to have children. If the injury to the spermatic cord is extreme and cannot be repaired safely, the affected man could require surgery to remove one or both of his testicles.
- Testicular ischemia – When men have a PerFix™ Plug implanted in the groin area, they can develop blood loss to the testicles (ischemia). This blood loss is due to mesh constriction and mesh cutting off regular blood flow to all areas of the body. Some men have testicular shrinkage associated with this complication, and some men end up requiring removal of the testicles.
- Bowel Obstruction – After surgery to repair a hernia using a PerFix™ Plug, inflammation and scar tissue can form and close off the small or large intestine. The mesh can also adhere to the intestines, causing intestinal bowel incarceration. When a patient has a bowel obstruction, normal digestive function is impeded because stool cannot travel all the way through the intestines. This leads to a number of serious and painful medical issues. Bowel obstructions must be repaired with additional surgery.
If you had surgery to implant a PerFix™ Plug and developed one of the above injuries, you might be entitled to compensation. Stern Law’s passionate team of lawyers can help you understand your options and start working toward a successful resolution for you and your family.
The Problem with Polypropylene
Many of the above injuries can be traced back to the polypropylene material used to create the PerFix™ Plug. Polypropylene is a thermoplastic polymer. It is essentially a hard plastic, of the same kind used for ropes, pill bottles, and carpet backing. Mesh manufacturers do their best to differentiate between the different ways polypropylene can be used, using terms like “medical grade” versus “commercial grade,” but this substance does not belong in the human body.
When patients undergo implantation of polypropylene mesh, their bodies begin a rapid acute inflammatory response called a “foreign body reaction.” The process initiates because the patients’ bodies understand that the implant is not natural. The body immediately begins working to isolate the unnatural material from the rest of the body, which results in chronic inflammation and an ongoing accumulation of rigid scar tissue to encapsulate the mesh.
Manufacturers try to argue that the inflammation and foreign body reactions patients experience after implantation of this mesh are actually positive side effects. In fact, the PerFix™ Plug mesh is actually designed to encourage immediate and chronic scar tissue formation. The mesh is filled with tiny holes, like a fishing net, to allow tissue to inflame and grow into the implant. The ingrowth of tissue is supposed to create a reinforced wall that keeps the herniated tissue in place. Rather than calling it adhesions or rigid scar tissue formation, Davol and Bard call it “tissue integration.” But through time, patients continue to experience inflammation and tissue encapsulation, which leads to pain, infection, nerve damage, and a host of other injuries.
In addition, this tissue embedment makes removal of the implant nearly impossible. Many injuries from the PerFix™ Plug eventually necessitate removal of the implant, but when surgeons encounter thick scar tissue all around the mesh, they are faced with the tedious task of trying to separate the patient’s healthy tissue from the encapsulated mesh. All too frequently, surgeons are unable to completely remove the mesh, and patients are left to suffer from pieces permanently remaining in their bodies.
PerFix™ Plug Reports to FDA
Manufacturers, doctors, and 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 the PerFix™ Plug. Some of these reports include the following descriptions:
- In August 2017, a patient’s attorney reported a patient underwent surgery to repair a right inguinal hernia using a PerFix™ Plug. Following the surgery, the patient developed complications and had to have another surgery to remove the implant. The patient experiences ongoing pain and is disabled due to the mesh injuries.
- Also in August 2017, a patient reported having surgery to repair an inguinal hernia using the PerFix™ Plug. Since implantation, the patient has experienced pain and has been told the implant needs to be removed. The patient has ongoing severe pain, unresponsive to treatment and lifestyle adjustments, and also reports inflammation and sexual dysfunction.
- Also in August 2017, a patient reported having a PerFix™ Plug implanted to repair a hernia. A few years after surgery, the patient began experiencing pain and nerve entrapment symptoms in his leg and groin. He reported feeling the mesh harden and “dig into [his] left testicle.” The patient reported being close to claiming disability because of the pain. He described the pain as “like somebody stabbed me in the groin with something hot and left it there.” He also reported sexual dysfunction and rashes from the polypropylene. The patient further stated the mesh had folded, hardened, moved, and created scar tissue. He said his colon was irritated from the scar tissue, and he had anal leakage. Because of all of his complications, he also now has high blood pressure.
- Also in August 2017, a patient reported having a PerFix™ Plug implanted for hernia repair. Since that surgery, the patient has had six additional surgeries to try to correct her mesh complications and address her hernia. She developed an infection postoperatively from the PerFix™ Plug, and the implant migrated. She underwent several rounds of antibiotics and then had surgery to remove infected tissue. During surgery, the patient’s surgeon discovered a fistula connected to the mesh. The PerFix™ Plug was removed, and the surgeon implanted a different device for the hernia. The patient’s infection persisted, and she had a wound vac placed. She has fought the infection for six years, she reported, and can no longer perform any substantial physical activity. She is on disability and has to rely on her children to take care of her. She reported being disfigured from all the surgeries and losing a lot of abdominal tissue. She also has nerve damage and must wear an abdominal brace for the rest of her life.
- In July 2017, a patient reported a reaction to a PerFix™ Plug after having it implanted for hernia repair. Two weeks after implantation [during which he also had a Bard Ventralex mesh implanted], the patient returned to his surgeon with red, itchy skin at the site of the inguinal repair. He was given prednisone, which resolved the symptoms. A while later, he began to experience dermatographia with muscle aches, pain, redness, and itchy skin. Mesh sensitivity could not be ruled out as the cause.
- Also in July 2017, a surgeon reported attempting to implant a PerFix™ Plug in a patient for hernia repair. As the surgeon was trimming the onlay portion of the plug and patch, the surgeon discovered the material had frayed. The surgeon removed the PerFix™ Plug and proceeded with a different implant. The surgeon returned the implant to Davol for inspection. Davol confirmed the product was frayed and contained a suture, suggesting the surgeon had attempted to implant it.
- Also in July 2017, a patient reported undergoing emergency surgery to repair bilateral incarcerated inguinal hernias. The patient was implanted with two PerFix™ Plug implants. A few weeks after surgery, the patient began to experience significant pain in his groin, abdomen, and testicles, which the patient described as “burning, ripping, and pulling” sensations. Additionally, he experienced abdominal bloating, bowel issues, and frequent vomiting. Through the course of four years, the patient’s pain and discomfort increased in severity, and he sought medical attention. He underwent various imaging studies and was advised that doctors could see inflammation and scarring around the mesh, but the scar tissue made it difficult to visualize the mesh. Upon further examination, the patient was advised that the pain he was experiencing was related nerve damage from the scarring and inflammation around the mesh at the location of the spermatic cord. He was also advised that his left inguinal hernia had recurred. The patient underwent surgery to repair his left hernia again, this time using a different Bard implant. The surgeon noted significant adhesions from his first surgery. The patient continued to experience pain and vomiting and again developed a sensation of ripping in his left groin and radiating to his abdomen. Upon examination, it was discovered the left inguinal hernia had again recurred. The patient then underwent a third surgery to remove the PerFix™ Plug on the left side and readdress the hernia. His operative report indicates the old hernia plug [the PerFix™ Plug] had extruded to be firmly adhered to the spermatic cord. The PerFix™ Plug was explanted while trying to preserve the left testicle. The patient continues to suffer from chronic nerve pain, pelvic pain, nausea, hernia recurrence, and vomiting. His injuries interfere with his employment, as he has been unable to work since 2013, and he is unable to assist with many daily tasks.
- In June 2017, a patient’s attorney reported that a patient underwent open hernia repair using a PerFix™ Plug. Within the first year of surgery, the patient began to experience a feeling of tightness in his lower left abdomen in the location where the mesh had been implanted. The pain increased through the second year, descending into his left testicle. During this time, the patient gradually became unable to empty his bladder, and he had to begin self-catheterizing three times a day in order to urinate. The patient went to several doctors who could not determine the cause of his issues. He then went to a urologist who performed an MRI on the patient’s pelvic area and concluded the patient was experiencing a significant reaction around the mesh, with “nonspecific fascial thickening overlying the hernia repair.” The patient underwent surgery to remove the PerFix™ Plug. During surgery, it was discovered the PerFix™ Plug was wrapped around his spermatic cord, and the patient’s left testicle had to be removed in order to fully remove the PerFix™ Plug implant. The patient continues to be unable to urinate, has chronic and severe testicular pain, experiences pain during sex, nausea, and has permanent disfigurement.
- Also in June 2017, a patient reported being implanted with a PerFix™ Plug for repair of a right inguinal hernia. Postoperatively, the patient has suffered from multiple side effects, including several infections, seroma/hematoma, swelling, nerve entrapment, mesh migration, and chronic and debilitating pain. The patient also reported being permanently disfigured. The patient reported that her doctors had advised that that, due to the migration of the PerFix™ Plug and its current proximity with respect to her femoral artery, any surgery to attempt to remove the mesh implant could prove fatal. She continues to have the same problems, and the PerFix™ Plug has not been removed.
- In May 2017, a patient reported undergoing hernia repair surgery with a PerFix™ Plug. After surgery, she began to experience pain at night when her bladder was full. She presented to her doctor with complaints of a “burning sensation behind [her] belly button.” The doctor performed an abdominal exam and noted the patient was in a lot of pain and had tenderness in the abdomen. The doctor ordered a CT scan that ultimately showed the patient needed exploratory surgery. During the surgery, the surgeon discovered the PerFix™ Plug was “balled up.” The surgeon had to remove scar tissue and straighten out the mesh. The surgeon concluded the burning sensation was because of the mesh, and the patient wishes at this time to have the implant removed.
These are merely a few in the large volume of serious complications reported to the FDA about the PerFix™ Plug in the summer of 2017 alone. Despite knowing about the potential for the PerFix™ Plug to cause dangerous postoperative injuries, the FDA has taken little to no action. It has not recalled the PerFix™ Plug™ and has not issued any statements specifically addressing the safety of these implants.
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 role mesh played in these injuries by stating that the same injuries could occur after all hernia repair surgeries, with or without the 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 these complications. We find this bewildering, given that our clients continue to report serious injuries from their hernia mesh implants, including the PerFix™ Plug™, and given that these products have not been recalled.
How Do I Know Whether I Have a PerFix™ Plug?
In order to file a lawsuit against Bard (the mesh manufacturer), a person must be able to prove he or she had one of Bard’s products. Many times, patients who undergo hernia repair surgery do not know the exact name of the product used, and in some cases, aren’t truly sure whether the surgeon used mesh at all. Surgeons typically spend time with the patient explaining the procedure to be performed and the projected results, rather than discussing the individual instruments they will use. For this reason, few of our clients know what product they have when they first contact us.
When you sign up with Stern Law, we do that work for you by immediately ordering your medical records from your original hernia repair surgery. Included in our records order, we request copies of the intraoperative notes and implant reports from the day of your surgery. Those records will usually contain a product sticker or lot number that identifies the specific brand and manufacturer of your mesh implant. We call this sticker or lot number “product identification.”
Once we have identified that you indeed have a PerFix™ Plug, we can begin verifying your injuries and building a solid case we can bring against the manufacturer. If your records indicate you do not have a PerFix™ Plug, we will try to include your claim in one of the other hernia mesh cases we handle.
Hernia Mesh Litigation News
The hernia mesh litigation is quite large because there are many manufacturers involved and even more types of hernia mesh products. In litigations of this magnitude, 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.
Potential Compensation for PerFix™ Plug Injuries
The attorneys at Stern Law know your PerFix™ Plug injuries have changed your life, and we are committed to helping you receive just compensation. When you file a claim for damages against Davol and Bard, you can recover for all of the ways you have been harmed by PerFix™ Plug mesh. This includes claims for the following types of compensation:
- Lost wages, if you missed work or cannot currently work because of your hernia mesh injuries;
- Lost future wages, if you will not be able to return to work;
- Past medical bills for treatment related to your hernia mesh injuries;
- Future medical bills, if you will need additional treatment for your injuries;
- Compensation for the physical and mental pain and suffering you have incurred and will incur as a result of your hernia mesh injuries;
- Loss of consortium damages for the ways in which your injuries have affected your marriage, including loss of love, society, companionship, affection and support; and
- Punitive damages, where the circumstances of the litigation show an award that carries the effect of punishment for the manufacturers would be appropriate.
When you hire Stern Law, we will help you calculate the full extent of your economic and noneconomic damages to maximize the amount you and your family receive.
Contact Stern Law, PLLC
If you or a loved one underwent an operation to repair a hernia and experienced an injury following surgery, contact Stern Law, PLLC today. We have the skills and resources to protect your rights, and we can start with a confidential consultation at no cost to you. Contact us by calling (844) 808-7529, and schedule your free consultation with one of our experienced product liability attorneys.