Bard Sepramesh IP Composite
Hernia mesh is often used in hernia repair surgery to strengthen weakened tissue. Hernia mesh is also thought to reduce the risk of a hernia re-occurring. C.R. Bard’s Sepramesh IP Composite Mesh was approved in 2004 and featured the company’s newly acquired Sepra Technology. It was designed to reduce adhesion to surrounding organs, but some patients say the mesh is causing serious injuries and complications. These patients are now filing lawsuits against Bard for failing to warn about the mesh’s potential risks.
Bard Sepramesh IP Lawsuits
Did you suffer complications after being implanted with Sepramesh IP Composite during your hernia repair? If you developed complications such as infection, recurrent hernia, the need for a second surgery or other injuries, you may be entitled to financial compensation. There may be significant payouts or cash settlements for those affected by the hernia mesh.
People who experienced complications following a hernia repair surgery with Sepramesh IP Composite Mesh are filling lawsuits against its manufacturers: C.R. Bard Inc. and subsidiary Davol Inc. People report suffering injuries such as infection, inflammation, pain, recurrent hernia and the need for a second surgery and are seeking financial compensation for their injuries.
Bard Sepramesh IP Lawsuits accuse C.R. Bard and Davol Inc. of numerous legal claims, including negligence and failing to warn the public about the potential risks of the mesh.
Sepramesh IP lawsuits accuse the manufacturers of several counts, including:
- Designing and manufacturing a defective product
- Failing to warn about Sepramesh IP’s potential risks
- Negligently designing, manufacturing and selling a faulty hernia mesh
- Strict liability for manufacturing a defective product
- Breach of express and implied warranties
Hernia mesh lawyers and attorneys are now accepting Sepramesh IP cases nationwide. These lawsuits are different from class action lawsuits, which are filed by one or more individuals on behalf of many. Verdicts and settlements awarded in these types of personal injury cases are handed down individually and not split equally among plaintiffs like in a class action lawsuit.
Bard Sepramesh IP lawsuits are in the early phases of discovery. No lawsuits have gone to trial and no settlements have been awarded in the Sepramesh IP litigation as of March 2017.
Harmful Mesh Material
Sepramesh IP Composite contains the controversial plastic-like material polypropylene. This material is believed to contribute to certain mesh complications, including an increased risk of adhesion. When the polypropylene is exposed to internal organs, it can adhere to those organs and cause further injury.
Some hernia mesh products, including Sepramesh IP, are coated with special material to decrease the risk of adhesion. These meshes are called composite mesh, but some coatings have been linked to complications of their own.
What is Hernia Mesh?
Hernia mesh is a specific type of surgical mesh used in hernia repair surgery. It is a screen-like medical device that provides support to weakened or damaged tissue caused by hernias. Hernias occur when an organ pushes through an opening or weakness in the surrounding tissue.
Hernia mesh can help lower the risk of a hernia re-occurring, but the devices have also been linked to complications and injuries.
There are a number of different brands of hernia mesh used in the U.S. today and each are made from various materials. In general, hernia mesh can be made from synthetic materials or animal tissues. Mesh made from animal tissue is absorbable and will eventually be excreted by the body. These types of mesh are not intended to provide longterm support to weakened tissue.
Mesh made from synthetic material can be either absorbable or nonabsorbable. Nonabsorbable mesh is considered a permanent implant and is intended to remain in the body indefinitely. The materials used to make synthetic mesh have been shown to increase the risk of complications, especially the plastic-like material polypropylene.
Sepramesh IP Composite Mesh
Bard’s Sepramesh IP Composite Mesh is a partially absorbable composite mesh made from synthetic materials. A composite mesh is one that contains some sort of coating on one or all sides of the mesh.
Sepramesh IP is made from the plastic-like materials polypropylene and polyglycolic acid (PGA). The PGA side of Sepramesh IP is coated with an absorbable hydrogel made from sodium hyaluronate, carboxymethylcellulose and polyethylene glycol. The polypropylene side is left uncoated, which Bard claims allows for faster tissue ingrowth to help support weakened tissue.
The absorbable hydrogel coating is designed to keep organs and other tissues from adhering to Sepramesh IP in the weeks following surgery. The coating is slowly absorbed and excreted by the body – usually within 30 days.
Bard’s Sepramesh IP uses technology first approved by the U.S. Food and Drug Administration (FDA) in 2000. The original Sepramesh was designed and manufactured by biotech firm Genzyme Corporation. Genzyme was acquired by French pharmaceutical giant Sanofi in 2011 for $20 billion.
In 2007, Bard announced an agreement with Genzyme to manufacture and market Sepramesh. The medical device giant also said it would incorporate Sepra Technology into its own hernia mesh products.
The FDA cleared Sepramesh IP Composite Mesh for use in hernia repair in 2004. The device was approved through the agency’s 510(k) Premarket Approval program, meaning it did not have to undergo rigorous testing to determine its safety and effectiveness. Its manufacturer, Genzyme at the time, only had to show that Sepramesh IP was as safe and effective as similar devices already on the market. (The original Sepramesh was also approved through the 510(k) clearance program.)
Sepramesh IP is a modified version of the original Sepramesh. It is designed using PGA, as well as polypropylene and an absorbable coating. The original Sepramesh used only polypropylene and a coating.
Other Sepramesh Products
Since the approval of the original Sepramesh in 2000, the FDA has approved several other versions of the mesh.
Sepramesh products approved by the FDA include:
- Sepramesh (2000) — the original Sepramesh product made from polypropylene and an absorbable coating
- Sepramesh IP (2004) — a modified version of Sepramesh made from dual-woven polypropylene and PGA and coated on one side with an absorbable coating
- Sepramesh IP (2005) — a second version of Sepramesh IP utilizing natural beige PGA fibers, an alternative to the 2004 Sepramesh IP’s violet-dyed PGA fibers
- Sepramesh IP (2007) — a larger 12”x14” version of Sepramesh IP
Sepramesh IP Complications & Side Effects
Sepramesh IP has been shown to adhere to surrounding tissues and organs and has been linked to other complications of hernia repair surgery.
Some complications and side effects linked to hernia mesh products like Sepramesh include:
- Chronic pain
- Hernia recurrence
- Allergic reaction
- Fluid buildup (seroma)
- Abnormal collection of blood outside a blood vessel (hematoma)
- Fistula formation
- Tissue or mesh erosion
- Need for additional surgeries (revision surgeries)
Adverse Event Reports
More than 50 adverse event reports have been submitted to the FDA regarding Sepramesh IP. Adverse event reports are submitted by manufacturers, physicians, hospitals, patients and attorneys representing those patients.
These adverse event reports show the variety of injuries caused by defective Sepramesh IP products.
A physician-submitted report from September 2016 details a man’s experience with Bard’s hernia mesh. The man was implanted with Sepramesh IP in 2013 during surgery to repair an abdominal wall hernia. The report states that 3 years later, the man underwent revision surgery to repair a recurrent hernia, during which surgeons discovered the Sepramesh IP had adhered to his colon.
Other Problematic Bard Mesh Brands
Bard markets other hernia mesh brands that are associated with complications and injuries. The brands have come under scrutiny from the FDA and have been subject to recall in the past.
Bard 3DMax Mesh
Bard’s 3DMax Mesh is a synthetic mesh made from polypropylene. Its curved “3D” shape is designed to fit in the inguinal (groin) cavity, but the mesh can be used in any hernia repair and chest wall defect repairs.
A modified version of the device was approved in 2008 through the FDA’s 510(k) clearance program. As a result, no studies were conducted in people to test the device’s safety and effectiveness.
3DMax was the subject of a class III recall in 2008, the same year the modified mesh was approved by the FDA. When a recall is classified as class III, it means the use of the recalled product is not likely to cause adverse health consequences.
Bard initiated the recall because of a mixup in packaging. 3DMax Mesh is available in two orientations — Left and Right. The recalled products were not packaged correctly and some Right 3DMax meshes were placed in Left 3DMax boxes.
The recall affected about 230 units nationwide and was finally terminated in 2012.
Bard Ventralex ST Hernia Patch
Bard’s Ventralex ST Hernia Patch is a combination of the company’s original Ventralex Hernia Patch and Sepramesh IP Composite Mesh. The mesh is made of two layers: the first is made from polypropylene and the second is made of both polypropylene and PGA. It is also coated on one side with an absorbable hydrogel.
Ventralex ST was approved in 2011 through the FDA’s 510(k) program and did not undergo rigorous clinical testing before it came on the market.
In 2011, the same year the mesh was approved, Bard recalled 96 units of Ventralex ST because of a labeling mixup. Bard sent an Urgent Medical Device Recall letter to healthcare providers telling them to check their stock of Ventralex ST. The company mistakenly packaged medium-sized Ventralex ST patches in large-sized boxes.
The FDA classified the recall as class II, which means there is a chance the device could cause temporary or reversible health problems but the chances of developing serious health problems are remote.
Bard eventually terminated the recall in 2013.
Hernia Repair Surgery
Hernia repair surgery is one of the most common surgical procedures performed in the United States — more than 1 million surgeries are performed each year. Inguinal hernia repairs are the most common type of hernia repair surgery. These are surgeries to repair a hernia of the inner groin. About 800,000 of the 1 million annual surgeries performed are inguinal hernia repairs.
Types of Hernia Repair Surgery
There are two main approaches to hernia repair surgery: laparoscopic and open repair.
In laparoscopic hernia repair, surgeons make small incisions in the abdomen and use special tools to reach and repair the hernia.
Since laparoscopic surgery is minimally invasive, it is generally associated with better surgical outcomes compared to open repair. Patients who under laparoscopic repair typically recover faster and experience less pain compared to open repair.
However, at least one study comparing the two approaches found patients did not experience less pain following laparoscopic repair and the rate of hernia recurrence were comparable between the two surgery approaches.
Laparoscopic hernia repair is also more costly and can take much longer to perform than open repair. The typical recovery time for laparoscopic hernia repair is about 1-2 weeks.
In open repair, surgeons make larger incisions near the hernia to repair it. Patients who undergo open repair may experience longer recovery times compared to laparoscopic, but the procedure is typically less expensive.
Recovery time for open repair is about 3 weeks compared to 1-2 weeks for laparoscopic.
Hernia Mesh Surgery Complications
There are various risks associated with hernia repair, as there are with any type of surgery. However, hernia mesh may increase the risks for complications and injuries.
The FDA conducted a review of adverse events reports and peer-reviewed scientific literature to determine the most common complications of hernia repair surgery.
The most common adverse events — regardless if hernia mesh was used in the repair or not — were:
- Hernia recurrence
- Adhesion (scar-like tissue that sticks together)
- Obstruction (blockage of the large or small intestine)
- Fistulas (abnormal connections between organs, vessels or intestines)
- Seroma (fluid buildup at the surgical site)
- Perforation (hole in nearby organs or tissues caused by the mesh)
When mesh was used during the procedure, the FDA found the most common complications were:
- Hernia recurrence
- Bowel obstruction
- Mesh migration
- Contraction (mesh shrinkage)
Hernias occur when an organ pushes through a weak spot in the tissue or muscle that surrounds it. Most hernias are caused by pressure pushing on the weak spot, which then pushes an organ or tissue through the area.
Hernias can be caused by a number of different factors. Risk factors for hernias include:
- Muscle weakness present at birth
- Lifting heavy objects
- Diarrhea or constipation
- Persistent coughing or sneezing
- Poor nutrition
Types of Hernias
Hernias can occur in different areas of the body. The most common types of hernias are:
- Inguinal — occurs in the inner groin (most common)
- Femoral — occurs in the upper thigh or outer groin
- Incisional — occurs through an incision or scar in the abdomen
- Ventral — occurs in the abdominal wall
- Umbilical — occurs at the belly button
- Hiatal — occurs near the upper stomach or diaphragm
People may notice a hernia when a bulge appears in the area where it occurred. Other hernia symptoms are also possible and may depend on where the hernia is located.
Hernia symtoms include:
- Bulge in affected area
- Pain or discomfort in the affected area
- Burning or aching sensation at the site of the bulge
- Weakness, pressure or a feeling of heaviness in the abdomen (inguinal hernia)
- Chest pain, difficulty swallowing, acid reflux (hiatal hernia)
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FDA. Sepramesh IP Composite Mesh 510(k) Premarket Notification (K053066). (December 2005). Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053066.pdf
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