If you have suffered an injury or pain and suffering as a result of Ventrio hernia mesh, you should consider filing a Ventrio surgical mesh lawsuit. A Ventrio hernia mesh lawsuit will pave the way top a potential Ventrio hernia mesh settlement 2018.

Bard / Davol Ventrio ST Mesh Lawsuits

Surgical mesh is a screen-like medical device that reinforces bone or tissue. Surgical mesh has been used in tens of thousands of surgeries in the United States for everything from pelvic organ prolapse to hernia repair. Mesh has been used to treat hernias alone since the 1950s, according to the FDA. This mesh is designed to be permanently implanted to reinforce a weakened abdominal wall. Many complications have been reported with recalled surgical mesh products that have since been recalled from the market.

C.R. Bard, Inc. is one of several manufacturers facing hernia mesh lawsuits alleging it failed to warn patients and physicians about the risks from its hernia mesh hernia patches. If you were injured after hernia repair with Bard Ventrio ST mesh, you may have a claim for damages.It is not necessary that your hernia mesh be recalled or subject to a recall in order to file a hernia mesh lawsuit

Hernias and Surgical Repair | Ventrio hernia mesh lawsuit

A hernia happens when fatty tissue, an organ, or intestine prolapses through a weak spot or hole in surrounding connective tissue or muscle. Hernias may look like an external bulge when straining. Hernias can occur in many areas of the body:

  • Inguinal in the inner groin
  • Umbilical at the belly button
  • Femoral at the upper thigh
  • Ventral in the general abdominal wall
  • Incisional through an incision in the abdomen
  • Hiatal inside the abdomen at the upper stomach

Every year, more than 1 million hernia repair surgeries are performed every year in the United States. Open repair is sometimes performed but most repairs are done laparoscopically through a small incision. Because hernias have a high rate of recurrence, hernia mesh is often used to reinforce the weak area.

What Is Ventrio ST Mesh?

The Ventrio ST patch is surgical mesh designed to reinforce weakened tissue that allows an organ to bulge and cause a hernia. This patch is manufactured by Davol Inc., a subsidiary of Bard, Inc. The Ventrio ST patch is an oval-shaped patch made from polypropylene mesh with woven monofilament fibers. The patch is used to laparoscopically repair hernias in multiple locations in the body.

The Ventrio ST is one of several mesh products Davol produces uses its Sepra technology, a hydrogel barrier on one side of the mesh that is designed to reduce tissue attachment to the mesh for protection while the body heals. Initially, after the mesh is placed, the hydrogel barrier swells but is reabsorbed within 30 days.

Many victims are seeking the best hernia mesh laws firms to file a Ventrio hernia mesh lawsuit. Victims hope that their Ventrio mesh lawsuit will result in a Ventrio settlement 2018 or a Ventrio hernia mesh settlement 2019.

FDA 501(k) Pathway and Bard Mesh | Ventrio mesh lawsuit

Hernia mesh products produced by Bard are Class II devices which indicate they have more than a minimal potential for harm and are “substantially equivalent” to a device previously approved by the FDA in characteristics and intended use. This means Bard surgical mesh intended for hernia repair did not go through an extensive FDA approval process necessary for Class III devices. Instead, the surgical mesh went through a shorter Premarket Notification Program.

To begin marketing a Class II device, Bard had to demonstrate that its mesh was at least as safe and effective and mostly equivalent to similar devices the FDA approved in the past. This streamlined 501(k) process does not require that the manufacturer prove the product is safe for its intended use.

Post-approval, the FDA has advised consumers that adverse events are possible as a result of using hernia surgical mesh products after receiving many complaints about hernia mesh. The most common adverse events include hernia recurrence, adhesion, infection, pain, and bowel obstruction.

Ventrio ST Mesh Injuries

Bard has faced many lawsuits alleging its hernia repair mesh is defective and unreasonably dangerous. One lawsuit filed by a Tennessee woman alleges she was implanted with Bard mesh months before a recall over a risk that authentic product was mixed with counterfeit product. After her surgery, she suffered injuries and deformity that included infection, hernia recurrence, pain, adhesion, bowel perforation, and obstruction. She also had to undergo several surgeries to find and remove the recalled Bard mesh and repair the tissue.

Many people who have undergone hernia repair surgery using a Bard Ventrio ST patch have experienced complications that have led to additional treatment, pain, and sometimes additional surgery. The most common injuries associated with Bard Ventrio ST mesh include the following.

Pain

A common complication of Ventrio ST hernia mesh is postoperative pain. For some people, this develops into chronic and debilitating pain that interferes with daily activities.

Infection

Many people have suffered an infection after having a Bard hernia mesh implanted. Sometimes antibiotics are enough to clear up the infection but sometimes infection is severe enough that it requires additional surgery.

Adhesion

An adhesion is thick scar tissue that sticks to organs and may cause pain and the need for corrective surgery.

Mesh Shrinkage

Ventrio ST mesh is made from polypropylene, a type of plastic that tends to shrink or contract over time. When the mesh shrinks, it can become detached from the underlying tissue and cause a hernia recurrence, mesh migration, or other serious complications.

Mesh Breakage

Sometimes the Bard hernia mesh breaks, particularly near the edges, which can cause a hernia recurrence and other complications.

Mesh Erosion

Erosion happens when the polypropylene breaks down through surrounding tissue. Erosion can be very painful and lead to perforation of organs, infection, and corrective surgery.

Mesh Migration

Many patients have experienced mesh migration with the Ventrio ST patch. This happens when the mesh migrates out of position or to another area of the body. This can lead to hernia recurrence, perforation of organs, erosion, and other serious complications that require surgical intervention.

Bard Mesh Settlements | Ventrio settlement 2018?

Bard has settled thousands of lawsuits in the last decade related to its mesh failures. In 2015, Bard settled 2,970 lawsuits related to hernia mesh based on a claim filed by a woman who was implanted with the company’s transvaginal mesh product. The mesh allegedly did not provide relief but instead caused bleeding, infection, pain, and the need for several corrective surgeries. This case resulted in a final settlement of $119 million.

Bard paid out a settlement of $200 million in the same year to settle 3,000 claims with each plaintiff receiving about $67,000 due to complications from hernia mesh surgery. An earlier settlement came in a 2011 case in which Bard settled 2,600 cases in Rhode Island for $184 million.

References:
https://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/
https://my.clevelandclinic.org/health/articles/16298-surgical-mesh-use-and-complications-in-women
https://www.aboutlawsuits.com/monofilament-mesh-lawsuit-127916/