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.
Bard Sepramesh Hernia mesh lawsuit
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 2020? Will there be a global Sepramesh mesh settlement 2020?
Many victims of Sepramesh Hernia Mesh are seeking a sense of justice and compensation as a a result of the allegedly defective mesh. Victims are asserting that Sepramesh is defective and that they were not properly warned of the dangers of the mesh. Many victims are filing Sepramesh hernia mesh lawsuits seeking compensation and justice. Victims need to seek highly competent and effective legal representation, as soon as possible. As a result of the Bard mesh, sepramesh, victims need to retain top hernia mesh attorneys at the best hernia mesh law firm in the United States. Will there be a Bard Sepramesh mesh lawsuit settlement 2020?
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.
5/23/2020-update- Sepramesh hernia mesh lawsuits are now being filed in a consolidated proceeding in Rhode Island State Court. Victims in this proceeding may get an extended statute of limitations. The consolidated state court proceeding is for nearly all of the Bard / Davol hernia mesh made of Polyproplene. Sepramesh lawsuits are also being filed in a Federal Court consolidated Multidistrict litigation in the Southern Distract of Ohio. Both cases are delayed as a result of COVID-19 but will begin bellwether / test trials soon.
Sepremesh and Sepramesh IP Composite History
- The original manufacturer of the surgical mesh, Sepramesh is Genzyme Corporation. Genzyme Corporation was located at 500 Kendall Street Cambridge, MA 02142. It was originally named SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX.
- It was marketed as featuring “Sepra Technology,” acquired by Genzyme
- Originally introduced by Genzyme Corp. and originally approved by FDA in 2000 as Sepramesh.
- On 03/02/2000 the FDA gave clearance to Genzyme to market SEPRAMESH pursuant to the controversial 510(k) premarket notification process. The 510k summary was required pursuant to 21 CFR 807.92 Read the 510(k) summary here.
- This hernia mesh medical device was approved without rigorous human clinical trials. Genzyme merely had to prove that Sepramesh was substantially equivalent to other mesh products. Genzyme asserted that Sepramesh was substantially similar to other hernia mesh that was on the market at that time: Bard Mesh, Bard Composix Mesh and Mersilene Mesh manufactured by Ethicon.
- On 06/04/2004 The FDA cleared Genzyme’s application to approve Sepramesh IP hernia mesh otherwise known as SEPRAMESH IP BIORESORBABLE BARRIER – PERMANENT MESH through the FDA’s controversial pre-market notification process. The manufacturer asserted that Sepramesh IP was substantially similar to several other meshes set forth below. The name of predicate device genzyme utilized asserting that such medical devices were substantially similar: Sepramesh™, Bard® Mesh , Bard® Composix® E/X Mesh, VicryFrM Knitted Mesh , Dexon® PGA Mesh. The original manufacturer was GENZYME CORP located at 500 Kendall Street Cambridge, MA 02142 Read the Premarket notification
- Sepramesh IP composite mesh has been used by surgeons to perform hernia surgeries since 2004-2005 time period..
- In 2007, Genzyme and Bard / Davol signed a manufacturing and marketing agreement. Bard would now incorporates Genzyme’s mesh technologies into its own hernia mesh devices and products.
- In 2007 C.R. Bard essentially purchased Sepramesh. “MURRAY HILL, N.J., Dec 17, 2007 (BUSINESS WIRE) — C. R. Bard, Inc. (NYSE: BCR) today announced that it has entered into a license agreement with Genzyme Corporation (Nasdaq: GENZ), headquartered in Cambridge, Massachusetts, to manufacture and market the Sepramesh® IP hernia repair product line and to incorporate the related Sepra® coating technology into the development of future hernia repair applications. Bard’s Davol subsidiary, located in Cranston, Rhode Island, will begin marketing the line immediately. Details of the agreement were not disclosed.” CR Bard press release
- Summary: 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.
The evolution of FDA approved Sepramesh medical devices
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.
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.
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.
Sepramesh IP Composite Mesh complications and symptoms
Patients whose doctors used Sepramesh may have experienced a range of complications, such as:
- Abdominal Pain
- Chronic Pain
- Bowel Adhesions or bowel obstruction
- Organ Perforation (hole in nearby organs or tissues caused by the mesh)
- Allergic Reactions
- Mesh Failure or Erosion
- Debilitating Pain
- Fistula Formation (abnormal connections between organs, vessels or intestines)
- Mesh Migration
- Hernia Recurrence
- Limited Mobility
- Leg Numbness
- Contraction (Mesh Shrinkage)
- Seroma (fluid buildup at the surgical site)
- Hematoma (abnormal pooling of blood, outside of blood vessels)
- Abnormal connections between organs
- blockage of the large or small intestines (obstruction)
- scar-like tissue that sticks tissues together (adhesion)
Adverse event reports
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.
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.
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.
Manufacturer of Sepramesh:
Bard and its subsidiary Davol is located at 100 Crossings Boulevard Warwick, RI 02886. The main Phone number is: 800-556-6756. The customer Service phone number is: 800-556-6275 The hours of operation: Mon-Fri 8:15am – 6:00pm EST, Fax 800-531-4124
Device Description of Sepramesh IP by manufacturer:
“Sepramesh™ IP Bioresorbable Coating – Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.” FDA 510k summary
Sepramesh settlement 2020
No hernia mesh lawyer could possible know whether Bard and their subsidiary Davol will settle all outstanding Sepramesh lawsuits in 2020. Will there be a hernia mesh settlement 2020? No hernia mesh attorneys could accurately predict whether there will be a surgical mesh settlement 2020. Many victims hold out hope for a global Sepramesh hernia mesh lawsuit settlement 2020. Perhaps Bard will settle a limited number of Sepramesh mesh lawsuits. Many victims are searching the internet to determine what the average hernia mesh settlement is. No hernia mesh lawyers can state what constitutes an average hernia mesh settlement.
Adverse event reports
|Event Date 07/01/2004|
|Event Type Other|
|I had a sepramesh placed in for a hernia in 2004. After the placement i have had a lot of very serious issues. I had developed pain in my abdomen as well as a continued almost daily fever of up to 103. After years of searching with exploratory surgery, cdc docs, and nuclear testing, i was told to review the listing of the fda. It seems there are several other cases to include mine having issues with this particular product. I have suffered a lot and just want some answers to this problem. I feel an investigation into this product should be looked at and something done because there is obviously a problem with it such as the kugel recall. If this is needing to come out i want it out. And, i want the public to be aware https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=840682|
“On (b)(6) 2002: pt underwent repair of a ventral hernia with a sepramesh. On (b)(6) 2003: pt has an infected abdominal wound and underwent removal of the sepramesh.’ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2540397
|It has been reported that in 2009 the patient underwent abdominal hernia repair and was implanted with a bard mesh device. As reported the hernia recurred and in 2011 the patient twice underwent emergency surgery and was implanted with a bard sepramesh. Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence and most recently in 2016 a bowel obstruction and hospitalization. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6234259&pc=FTL
(y) “(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall contain the following information:”Sec. 807.92 Content and format of a 510(k) summary. TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H–MEDICAL DEVICES,Subpart E–Premarket Notification Procedures PART 807 — ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES