Introduction
FDA Approval of Bard’s Ventralex ST
The Ventralex ST Hernia Patch is a medical device designed for repairing umbilical and small ventral hernias. It uses Sepra technology, featuring a hydrogel barrier on one side that prevents tissue attachment during healing while the uncoated side promotes tissue growth. This hydrogel barrier swells upon implantation and is resorbed within approximately 30 days after surgery. Made of polypropylene mesh with a SorbaFlex Memory ring, the device is designed to spring open and lay flat after insertion. Despite its FDA clearance, patients have reported complications including infection, chronic pain, migration, adhesions and bowel obstruction, leading to numerous lawsuits against manufacturer C.R. Bard and its subsidiary Davol.
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
- adhesions
- mesh breakage
- mesh shrinkage
- mesh erosion
- mesh migration
- bowel obstruction
Additional Literature
Interested in learning more about the ventralex hernia mesh lawsuit Read the following additional case literature.
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 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.
Frequently Asked Questions
Has the Ventralex mesh been recalled?
The Ventralex mesh has been subject to FDA safety actions, including recalls and market withdrawals affecting certain Bard Davol mesh products. If you received a Ventralex mesh and experienced complications, your surgical records can confirm the specific product used, which is an important step in evaluating your legal claim.
What is the Ventralight ST mesh and how does it differ from Ventralex?
The Ventralight ST is another hernia mesh product in the Bard Davol line. Like the Ventralex, lawsuits involving the Ventralight ST allege defective design and manufacturing. Both products have been named in lawsuits related to complications including chronic pain, mesh migration, and the need for revision surgery.
What is the current status of Ventralex mesh lawsuit settlements?
Settlement discussions and individual case resolutions are ongoing as part of the broader Bard Davol hernia mesh litigation. Because settlement amounts and case statuses vary widely, consulting with an attorney is the best way to understand the current landscape and how it may apply to your situation.
Am I eligible to file a Ventralex mesh lawsuit?
If you received a Ventralex or Ventralex ST mesh implant and subsequently experienced complications, you may be eligible to file a lawsuit. The strength of your claim will depend on factors such as the nature of your injuries, your medical history, and the timing of your diagnosis. An attorney can help evaluate whether you have a viable case.
