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. 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 2018?
Potential complications from Sepramesh:
- Severe pain and debilitating pain
- Abnormal connection between organs
- Blockage of the large or small intestine (obstruction)
- scar-like tissue that sticks tissues together (adhesion),
- 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)
- Hernia recurrence
- Bowel obstruction
- Mesh migration
- Contraction (mesh shrinkage)
- Intestines (fistula),
- Fluid build-up at the surgical site (seroma),
- A hole in neighboring tissues or organs (perforation)
- Source FDA
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
History of Sepramesh:
- 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.
- On 03/02/2000 the FDA gave clearance to Genzyme to market SEPRAMESH pursuant to the controversial 510(k) premarket approval 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.
- 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
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
On 06/04/2004 The FDA cleared Sepramesh IP 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 settlement 2017 | Sepramesh settlement 2018
No hernia mesh lawyer could possible know whether Bard and their subsidiary Davol will settle all outstanding Sepramesh lawsuits in 2017. Will there be a hernia mesh settlement 2018? No hernia mesh attorneys could accurately predict whether there will be a surgical mesh settlement 2018. 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