Bard, Inc. is one of the manufacturers that sell surgical mesh medical device implants.  Based on information from the U.S. Food and Drug Administration, surgeons have used surgical mesh for abdominal hernia repair since the early 1950s. The FDA fast tracked a number of Bard hernia mesh devices to use for hernia repair surgical procedures. The process is known as the 510k premarket notification process, and it doesn’t require clinical trials. The manufacturer only has to show that a similar device is already on the market

What the FDA Says About It

These mesh devices may not be as safe as what you might think. In fact, the FDA has made it clear that adverse consequences can crop up as a result of these hernia mesh devices. Even then, the FDA only made these warnings after dozens of complaints were filed because of hernia mesh devices. Based on information from the FDA, adverse consequences can come following the repair with the hernia mesh. Some of the potential consequences include infection, pain, adhesion, hernia recurrence and bowel obstruction. Some of the other dangers that can occur after hernia repair include mesh shrinkage and severe pain.

“Inguinal hernia repair with Spermatex: the first 100 cases.’

“Abstract: We evaluated 100 consecutive cases of surgical repair of inguinal hernia using SpermaTex (Davol, Cranston, RI) to assess postoperative outcome measures of early and late complications and hernia recurrence. SpermaTex is a bilayer surgical mesh prosthesis consisting of a fibrosis-inducing layer of polypropylene mesh bonded to a fibrosis-inhibiting layer of expanded polytetrafluoroethylene. One hundred male patients with unilateral primary inguinal hernia, with a mean age of 49 years, underwent hernia repair with the open anterior approach using SpermaTex. Mean operative time was 35 minutes; there was 3% morbidity and no mortality. At a 14-day follow-up, no patients had postoperative pain; within 2-8 weeks, all patients had returned to their presurgical health condition, with no inguinal pain. At follow-ups of 3 months to 4 years, all 100 patients experienced no recurrence, and all had improved, although 3 patients developed chronic sinus tracts. This series shows a favorable postoperative outcome profile for the use of SpermaTex in inguinal hernia repair.” https://www.semanticscholar.org/paper/Inguinal-hernia-repair-with-Spermatex%3A-the-first-Nicol%C3%B2/91163bba11707914e132e33702e3fc2a4bcafa3f

 

Adverse Consequences Linked to the Bard Hernia Mesh

Bard mesh is well  known for the complications and the adverse events that can sometimes arise. Some of the examples of these medical  devices that are subject to hernia mesh lawsuits include:

  • Spermatex 3D Max Mesh
  • Composix E/X Mesh
  • PerFix Plug
  • Sepramesh IP
  • Ventralex ST Hernia Patch

Spermatex hernia mesh

Based on what doctors wrote within the MAUDE database, complications and adverse events were common with this mesh. In fact, infections, unbearable pain, seroma, mesh migration, bowel obstruction, nerve damage and limited mobility were all potential consequences with this mesh.

Here is an  FDA adverse event report for Bard Spermatex hernia mesh:

Device Classification Name Mesh, Surgical, Polymeric
510(K) Number K991637
Device Name BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
Cranston,  RI  02920
Applicant Contact Rini Georgekutty
Correspondent
DAVOL, INC., SUB. C.R. BARD, INC.
100 SOCKANOSSETT CROSSROAD
Cranston,  RI  02920
Correspondent Contact Rini Georgekutty
Regulation Number 878.3300
Classification Product Code
FTL
Date Received 05/12/1999
Decision Date 06/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed By Third Party No
Combination Product No

Composix E/X Mesh

Consequences from this mesh include pain, adhesions, infections, corrective surgeries, fistula and a sore that doesn’t heal. It could even cause obstruction and disabilities. In one example, a male patient had hired a lawyer because of complications that happened with the Composix E/X mesh. Some of the problems that arose includes bowel obstruction, mesh perforation, fistula, vomiting, nausea and infected mesh.

PerFix Plug

Along with the potential pain in patients who had the mesh implanted, some of the other symptoms that arose include ambulation difficulty, abdominal swelling and a recurring hernia. In some cases, this led to permanent injuries.

Sepramesh IP

Based on the MAUDE reports, some of the adverse consequences of this one includes pain, bowel perforation and fever. Some other patients also experienced hernia recurrences and leg numbness. Some cases even had patients who needed to have emergency surgery or hospitalization.

Ventralex hernia mesh

Like with many of the Bard meshes, adverse consequences were reported. It included bowel obstruction and adhesions. In another event, there was a case where a patient had developed a wound that wasn’t healing.

The Bard Hernia Mesh Recall- spermatex mesh lawsuit

As of right now, neither Bard nor the FDA has come up with a Class I recall related to hernia mesh. With a Class I recall, this is the most urgent recall that can be issued. In fact, it means with reasonable probability that individuals could eventually experience major health consequences because of these meshes, or it could even result in their death. Despite the lack of recalls, the FDA has issued a Class 2 recall for some of the Bard hernia mesh products. Under a Class 2 recall, they aren’t considered as much of a life-threatening event, but the adverse consequences could still become a problem.

Bard Mesh Attorney- spermatex hernia mesh lawsuit

Have you ever had to undergo a revision or corrective surgery after a Bard hernia mesh had been implanted? Did you experience complications because of the surgery for your hernia repair? If so, there’s a chance that you could be entitled to some compensation. Through a qualified attorney, he will help you to understand your best course for legal action. Unfortunately, a growing number of people have come forward to say how this mesh gave them complications, or they experienced some pain as a result of the mesh being implanted. Depending on your circumstances, you could be entitled to  substantial compensation for your pain and suffering.

One of the first steps to figuring out if you have a valid claim is to check what kind of hernia mesh had been implanted in your body during the surgery. You should also look at whether it classifies as a hernia plug device or a hernia mesh. To get access to this information, you will have to ask for a copy of the operative report from your surgery.

If you believe that you or a loved one has suffered for a defective Bard mesh product, you should speak with a hernia mesh law firm as soon as possible. We have a team of qualified and experienced lawyers.

References:
https://www.weitzlux.com/defective-drugs-and-devices/bard-hernia-mesh-complications/
https://www.personalinjurylawcal.com/cases-we-handle/hernia-mesh-lawsuit/