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
- “SpermaTex: SpermaTeX is thumbnail in shape and constructed of small pore, heavyweight, unsuitable polypropylene mesh, with patch of ePTFE stitched to one side of the mesh at the rounded corner.” STATE 0F RHODE ISLAND SUPERIOR COURT PROVIDENCE, SC IN RE: DA VOL/ CR. BARD HERNIA MESH MULTI—CASE MANAGEMENT Coordination N0. 20 1 7-02 MASTER LONG FORM COMPLAINT AND JURY DEMAND
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 hernia mesh complications such as 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.’
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 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|
|Device Name||BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700|
|Applicant Contact||Rini Georgekutty|
|Correspondent Contact||Rini Georgekutty|
|Classification Product Code||
|Decision||Substantially Equivalent (SESE)|
|Regulation Medical Specialty||General & Plastic Surgery|
|510k Review Panel||General & Plastic Surgery|
|Reviewed By Third Party||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.
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.
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.
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.