The FDA has approved several Bard hernia mesh devices for use in hernia repair surgical procedures through the FDA 510(k) process. The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a “substantive equivalent” to a product or products already approved by the FDA. In fact, post-approval, the FDA has advised consumers that adverse events as a result of hernia mesh devices are possible. The FDA did so as a result of receiving a number of complaints about hernia mesh devices in general.(2)
According to the FDA, “[t]he most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).” (3)
Bard Mesh Approved Through FDA 510(k) Pathway
Surgical hernia mesh products on the market made by Bard are categorized as Class II devices.
A Class II device designation indicates that a new device carries more than minimal potential for harm and is “substantially equivalent” to a previously approved device in its intended use and characteristics or, lacking the latter, has demonstrated to the FDA that new questions of safety and efficacy have not been raised and that the device is “at least as safe and effective as the legally marketed device.” (4)(5)
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Bard surgical mesh products intended for hernia repair, and most hernia mesh devices, did not undergo the extensive FDA approval process required for Class III devices. Instead, they were reviewed under the 510(k) Premarket Notification Program. (6)
As Class II devices, Bard simply needed to “demonstrate” that its hernia mesh products were “at least as safe and effective, that is, substantially equivalent,” to similar devices the FDA has already approved. (7)
Bard Hernia Mesh Products Linked to Adverse Events
Bard hernia mesh complications and adverse events have been reported to the FDA’s Manufacturer and User Facility Device Experience database (MAUDE). Some examples of the devices mentioned in the MAUDE database include:
3D Max Mesh, Various Models
Complications and adverse events described in the MAUDE database for this mesh include debilitating pain, infections, mesh migration, seroma, revision surgeries, bowel obstruction, limited mobility, nerve damage, and numbness in the legs, among others.(8)(9)(10)(11)(12)
Composix E/X Mesh
The MAUDE database contains the following complications and adverse events for this mesh, among others: adhesions, corrective surgeries, pain, infection, fistula, nonhealing sore near the incision site, obstruction, and disability. (13)(14)
At least one male patient has hired an attorney who described complications occurring after the implantation of Bard’s Composix E/X mesh. These include nausea, vomiting, infected mesh, fistula formation, abdominal pain, bowel obstruction, small bowel erosion, abscess formation, mesh perforation, complex surgical procedures, and at least one visit to the emergency room.(15)
In addition to pain, one patient who had this mesh implanted experienced, according to his attorney, abdominal swelling, ambulation difficulty, recurrent hernia “incarcerated with mesh” as well as additional surgical procedures, and permanent injury.(16)
According to MAUDE reports, adverse events of Sepramesh IP include abdominal pain, fever, bowel perforation, bleeding complications, leg numbness, hernia recurrence, and bowel obstruction. In some instances, patients required hospitalization, emergency surgery, or intensive care.(17)(18)
Reported in another case, a patient experienced the recurrence of an abdominal hernia. The surgeon discovered the mesh had attached itself to the colon.(19)
In another case, the patient suffered numerous complications, including the puncturing of the small bowel by the mesh, as well as pieces of mesh attaching to the intestine and liver. During surgery to address mesh-related problems, the patient suffered a stroke.(20)
Ventralex ST Hernia Patch
As with other Bard models, adverse events reported for the Ventralex ST Hernia Patch include adhesions and bowel obstruction.(21)
In one instance, following hernia repair surgery, “the patient returned to the [OR] with a bowel obstruction and bowel was found to be twisted and adhered to the center of the ventralex st hernia patch … a secondary piece of bowel was [also] found to have adhered to the underside of the mesh as the mesh had ‘tacoed.’”(22)
In another event, it was “reported that the patient developed a non healing, draining wound … the patient was brought to surgery for a laparoscopic procedure. The mesh was found to have folded over with adhesions, including some to the bowel.”(23)
Bard Hernia Mesh Recall
So far, neither the FDA nor Bard have issued any Class 1 recalls for these Bard hernia mesh devices. An FDA Class I recall is the most urgent type of recall. A Class 1 recall means “there is a reasonable probability” of a person experiencing “serious adverse health consequences or death” if that person uses or is exposed to the product in its current form.(24)
However, the FDA has categorized a few Bard hernia mesh recalls for hernia mesh products as Class 2. Class 2 recalls are generally considered not life-threatening, but may pose temporary or “medically reversible” “adverse health consequences.”(25)
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Bard Hernia Mesh Attorney
Have you undergone a corrective, or revision, surgery after experiencing complications related to a hernia repair surgery? During the surgery, did you receive one of these Bard hernia mesh products? Has your physician recommended a revision surgery because of complications related to your Bard hernia mesh implant?
If so, you may be eligible to pursue compensation from Bard, Inc. An experienced Weitz & Luxenberg attorney may be able to help you determine if you are eligible to pursue legal action.
To find out more, the first step is contacting a Bard hernia mesh attorney, such as Weitz & Luxenberg’s Paul Pennock or Peter Samberg. In fact, they are two of the best in the business when it comes to handling litigation involving defective drugs and medical devices when large numbers of people have been injured.
“Unfortunately, more and more people are coming forward claiming they have experienced pain and other complications related to their Bard hernia repair mesh implants,” says Pennock.
He advises anyone facing such overwhelming circumstances to speak with an experienced attorney. “You definitely want someone who knows what they’re doing on your side,” Pennock emphasizes.
For 20 years, Paul Pennock has led the Drug and Medical Device Litigation group at Weitz & Luxenberg. Because of his knowledge and expertise, he has been charged with overseeing both state and federal cases, representing thousands of people injured by defective medical devices or drugs over the years.
“There’s nothing more rewarding than achieving a just verdict that helps hundreds, sometimes thousands, of people,” says Pennock. “The pharmaceutical companies and manufacturers of medical devices need to understand that the products they create and distribute have real consequences for real people. And people’s safety, health, and well-being should never be taken lightly.”
Bard Hernia Mesh Lawsuit
Now, Paul Pennock and the Weitz & Luxenberg Drug and Medical Device Litigation team are preparing to stand up to Bard, Inc., and other mesh manufacturers. They are doing so because certain hernia mesh devices are linked to severe medical complications and adverse events.
We’d like to hear from you if you have experienced any of the following complications and needed a revision surgery — or if your doctor has recommended that you undergo a corrective surgery due to these problems with your hernia mesh:
- Mesh failure
- Device migration
- Bowel obstruction
- Any other problems you think may be related to your Bard mesh implant
Depending on your circumstances, you may be eligible to receive compensation for current and future medical costs related to your injury. This could also include lost wages if you were unable to work and other costs you incurred because of your injuries.
Weitz & Luxenberg May Be Able to Help
Our attorneys are filing Bard hernia mesh lawsuits. These lawsuits are on behalf of clients who experienced serious complications, including revision surgery, related to Bard hernia mesh implants. In some cases, doctors have advised their patients to undergo corrective surgeries and patients have been unable to do so.
Contact us for a free consultation. You can reach us by phone at (877) 680-3753 or use the form on this page. One of our representatives will be in touch with you shortly.