Hernia Mesh Litigation
- Johnson & Johnson subsidiary Ethicon Physiomesh Flexible Composite Hernia Mesh
- Atrium Medical Corp. C-QUR Mesh
- C.R. Bard & subsidiary Davol, Inc. Composix Kugel Mesh Patch
Bard Composix Kugel Mesh Patch
The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
Hernia Mesh Bard Composix Kugel Mesh Patch Recall
Davol, Inc. started recalling the Kugel Hernia Patch in December of 2005 for all lots manufactured before 2006. Six different products in the patch line have been recalled. The reason for the recall is that the “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Kugel Hernia Patch Side Effects
- persistent dominal pain
- fever
- tenderness at the implant site
- other unusual symptoms
Kugel Hernia Patch History
Davol, Inc. reportedly received complaints as early as 2002. The company took no action at that time and asserted that the number of complaints was very small and didn’t require public notification. In 2005, Davol received 10 reports of ring breakage within a 3 month time frame. At this time Davol did not take responsibility and instead laid the responsibility with the doctors who didn’t implant the patch correctly. The FDA began an inspection of the Kugel Hernia Patch in the beginning of 2007, after the Kugel Hernia Patch recall.
In April of 2007, the FDA sent a warning letter to Davol citing several “serious regulatory problems” and that these problems directly contributed to the delay of addressing the problems with the Kugel Hernia Patch. These violations included:
- Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
- Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.
- Failure to document the implementation of corrective and preventive actions, as required by 21 CFR 820.100(b). For example, CAPA #Q6023, (opened on April 28, 2006 and closed on June 13, 2006), was initiated as a result of your class 1 recall of the Composix Kugel Hernia Patch due to ring weld breaks. This CAPA included the following specific action to be taken, “… establish complaint threshold limits for recoil ring break complaints & continue to monitor trends.” During the inspection, no documentation could be provided to our Investigator that demonstrated these limits had been established prior to closing of the CAPA.
- Failure to validate your device’s design to ensure that the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, there was no documentation to demonstrate that design validation was performed on your Salute Reusable Fixation device. During the inspection, we observed a performance specification for your Salute Reusable Fixation device which states, “. . .the reusable assembly shall be capable of producing [redacted] Q Rings without compromising performance”. There was no documentation available to demonstrate that any testing was performed to ensure that the Salute Fixation device met this specification.
- Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).
What is a Hernia? (from the FDA)
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall. Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.
Types of Hernias
The most common types of hernias are:
- Inguinal: occurs in the inner groin
- Femoral: occurs in the upper thigh/outer groin
- Incisional: occurs through an incision or scar in the abdomen
- Ventral: occurs in the general abdominal/ventral wall
- Umbilical: occurs at the belly button
- Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
Causes of Hernias
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.
Treatment Options for Hernias
Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias.1
- Non-Surgical
- Watchful Waiting – Your surgeon will watch the hernia and make sure that it is not getting larger or causing problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.
- Surgical
- Laparoscopic – The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
- Open Repair – The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.
Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques.
The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time. However, recovery time depends on the type of hernia, the surgical approach, and the patient’s condition both before and after surgery.
Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh. For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair2.
Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.
Surgical Mesh
Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.
Animal-derived mesh are made of animal tissue, such as intestine or skin, that has been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine) source.
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.
Hernia Repair Surgery Complications
Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).
The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
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.