Sepramesh IP composite is a polypropylene mesh material with a hydrogel safety coating. Sepramesh IP Composite was marketed by C.R. Bard and its subsidiary, Davol. Hernia mesh is frequently used by surgeons to support weakened abdominal tissues and to potentially reduce the patient’s risks of hernia recurrence.
If you are a victim of Sepramesh hernia mesh, contact a Sepramesh hernia mesh lawsuit attorney. None of the Sepramesh mesh lawsuits are class actions. Please contact us if you are interested in filing a sepramesh hernia mesh lawsuit. Any Sepramesh mesh lawsuit would be an individual lawsuit filed in State or Federal Court. There are no Sepramesh class action lawsuits at this time. There were no Sepramesh hernia mesh settlements in the past that were reported.Will there be a Sepramesh settlement 2018? Will there be a global Sepramesh mesh settlement 2019?
Bard / Davol Mesh – Sepramesh IP Composite
Sepramesh hernia devices were allegedly made with defective materials. The product’s lipid layers produced numerous chronic infections in recipients and delayed patients’ healing. This known defect caused thousands of Sepramesh patients to experience other serious complications.
What is Hernia Mesh?
Hernia mesh is a special kind of surgical mesh that’s intended for use in hernia repair surgical procedures. A hernia may result from a prior incision or because weakened tissues cause an organ or intestines to push through an open area. Different types of hernia mesh are used by surgeons in the United States today. Hernia mesh may be comprised of synthetics or organic animal tissue. Generally speaking, animal-derived mesh is more absorbable. Because of this, animal tissues aren’t used to support weakened tissues over the long-term.
In contrast, mesh created from synthetic materials may be viewed as a permanent implant. Non-absorbable hernia mesh can stay in the patient’s body for an indefinite time period. However, non-absorbable synthetic hernia mesh has been shown to raise the patient’s risk of complications, especially when plastic materials like polypropylene are used.
Is Bard Sepramesh IP Composite Mesh Absorbable or Non-Absorbable?
Bard Sepramesh IP composite mesh is created from synthetic materials. According to Bard / Davol, it’s “partially absorbable.” A “composite mesh” contains one or more coatings on one (all) side of the device. Sepramesh IP composite mesh is created from polyglycolic acid (PGA) and polypropylene. These are considered “plastic-like” materials. Sepramesh IP’s PGA-facing side is coated with polyethylene glycol, sodium hyaluronate, and carboxymethylcellulose. This is a type of hydrogel.
This absorbable coating is intended to prevent tissues and organs from forming post-surgical adhesions to the Sepramesh IP composite mesh device. Bard says the patient’s body typically excretes the coating within about 30 days. Sepramesh IP’s polypropylene-facing side is uncoated. Bard argues that the uncoated side enables faster tissue “in-growth” and helps to support weakened hernia tissue.
Sepramesh IP Composite History
Originally introduced by Genzyme Corp. and originally approved by FDA in 2000, Sepramesh IP composite mesh has been used by surgeons to perform hernia surgeries since 2005. It was marketed as featuring “Sepra Technology,” acquired by Genzyme .FDA later approved Sepramesh IP composite mesh for its intended hernia repair use in 2004 through the fast-track 510(k) (premarket approval).
In 2007, Genzyme and Bard signed a manufacturing and marketing agreement. Bard would now incorporate Genzyme’s mesh technologies into its own hernia mesh devices and products. Sepramesh IP was modified over the years. The original device used coating and polypropylene. This much-touted technology was intended to reduce the potential organ adhesions but, since that time, some patients and their doctors report the hernia mesh has caused serious complications and injuries.
FDA Approval of Bard / Davol Hernia Mesh Devices
According to the Food & Drug Administration (FDA), surgeons have used surgical mesh to perform abdominal hernia surgeries for almost 70 years. Several hernia mesh devices marketed by Bard were approved by the FDA 510(k) for use in hernia repair surgeries.
FDA’s 510(k) process doesn’t require the product manufacturer to show that its product is safe. Instead, the manufacturer is allowed to show that its entrant is a substantive equivalent to one or more products the FDA has previously approved. Bard’s surgical mesh products (and, in fact, most types of hernia mesh devices) weren’t submitted to the rigorous FDA approval process necessary for Class III devices.
Bard’s surgical hernia mesh devices are considered Class II devices. Because they were intended for use in hernia repair procedures, they didn’t undergo FDA’s extensive approval processes. Although FDA advised physicians and consumers that hernia mesh devices might result in “adverse events” post-approval, Bard and its subsidiary didn’t properly warn members of the public. The FDA also reported it had received numerous hernia mesh device complaints in general.
FDA-Approved Sepramesh Products
FDA approved additional Sepramesh products after it approved the original device in 2000, including:
• Original Sepramesh – made of polypropylene plus an absorbable coating, approved in 2000.
• Sepramesh IP – made of dually-woven PGA (one-sided absorbable coating) and polypropylene, approved in 2004.
• Sepramesh IP – made of “natural” beige-colored PGA (the 2004-approved device used dyed PGA fibers), approved in 2005.
• Sepramesh IP – made of dually-woven PGA (one-sided absorbable coating) and polypropylene in a larger size (12 inches by 14 inches), approved in 2007.
Sepramesh IP Composite Mesh Risks and Symptoms
Patients whose doctors used Sepramesh may have experienced a range of complications, such as:
• Abdominal Pain
• Chronic Pain
• Bowel Adhesions or Obstruction
• Organ Perforation
• Allergic Reactions
• Mesh Failure or Erosion
• Debilitating Pain
• Fistula Formation
• Mesh Migration
• Hernia Recurrence
• Limited Mobility
• Leg Numbness
• Mesh Shrinkage
• Seroma (fluid buildup)
• Hematoma (abnormal pooling of blood, outside of blood vessels)
Patients receiving Sepramesh might have required revision surgery. At least 50 reports citing adverse events and Sepramesh IP composite mesh have been received by the FDA. Hospitals, attorneys, patients, doctors, and manufacturers have submitted these adverse event reports concerning Sepramesh IP composite mesh to the FDA.
For instance, a doctor submitted an adverse event report in September 2016 concerning a male patient’s hernia mesh surgery. He received the Sepramesh IP composite mesh device in 2013 during an abdominal wall hernia procedure. Just three years later, the patient needed revision surgery to repair a hernia recurrence. His surgeon stated that the Sepramesh IP implant had formed adhesions to the patient’s colon.
Sepramesh Lawsuits Continue to Move Forward
News concerning Bard / Davol’s Sepramesh hernia mesh products prompted many bad medical product lawsuits to be filed. Recipients of Sepramesh and their surgeons learned that Bard / Davol didn’t fully warn the public about these product defects. Failure to warn patients has allegedly caused the suffering of countless victims. Lawsuits filed to date state that C.R. Bard / Davol knew about its Sepramesh hernia mesh product defects, but did nothing.
Bard Hernia Mesh Attorney
If you or someone you love underwent a revision or corrective surgical procedure after experiencing poor results relating to a hernia repair surgery, you should speak with a Bard hernia mesh lawyer as soon as possible. If you received a Bard Sepramesh IP composite mesh device during surgery, contact our Bard hernia mesh legal team now.
If your surgeon has recommended another surgery (a revision procedure) because you or your loved one experienced complications from a Bard hernia mesh device, don’t wait. You may have the right to compensation. Our experienced Bard hernia mesh lawyers can help you know if you’re eligible to file a hernia mesh lawsuit.