FDA Approval of Bard’s Ventralex ST
The FDA originally approved Bard’s Ventralex on July 16, 2002. Bard used the FDA 510(k) approval program for the Ventralex.
The FDA 510(k) approval program allowed Bard to skip pre-market clinical studies and research intended to ensure the safety of the Ventralex hernia mesh. In order to get approved, Bard claimed the Ventralex was substantially similar to its Kugel mesh.
History of the Case
In 2012, Davol issued a voluntary recall of the product because of mislabeling. The Ventralex™ patches come in several sizes, and Davol found out that a batch of its patches had been packaged in pre-printed cartons showing the wrong size.
In the recall, Davol advised customers to examine their inventory and quarantine affected products for return to the corporation. Davol corrected the problem and placed the product back into the market.
Injuries Related to Product
If you’ve experienced any of the following, you may have a claim in the ventralex hernia mesh lawsuit:
- Severe or chronic pain
- Serious infection
- mesh breakage
- mesh shrinkage
- mesh erosion
- mesh migration
- bowel obstruction
Interested in learning more about the ventralex hernia mesh lawsuit Read the following additional case literature.
Aug 2017:Mesh Erosion to Urinary Bladder Causing Fistulation to Abdominal Wall Resulting in Necrotizing Fasciitis: A Case Report of Late Complication of Incisional Hernia
Case report of a circular Ventralight ST mesh migrating 21 months after implantation, causing a fistula, which resulted in necrotizing fasciitis. The surgeons explained the process of mesh migration: “Secondary migrations are slow and gradual movement of mesh through transanatomnic planes. These are secondary to foreign-body reaction-induced erosion. In this case the migrated mesh transversed different anatomic planes and created a vesicocutaneous fistula, which implies secondary migration more likely.”
Sept 2015: Umbilical Hernia Repair: Analysis After 934 Procedures.
Jan 2014: Intraperitoneal Tension-Free Repair of a Small Midline Ventral Abdominal Wall Hernia: Randomized Study with a Mean Follow-up of 3 Years.
Oct 2011: Retrospective Analysis of Umbilical, Epigastric, and Small Incisional Hernia Repair Using the Ventralex Hernia Patch.
Jan 2011: Open Intraperitoneal Versus Retromuscular Mesh Repair for Umbilical Hernias Less Than 3 cm Diameter.
Dec 2010: Can Infected Composite Mesh Be Salvaged?
Jul 2009: Open Intraperitoneal Mesh Repair for Umbilical Hernias. A Technical Note.