Bard Mesh Recalls
The Bard medical corporation has been manufacturing the 3D Max as early as 2007 through it's subsidiary company Davol. This product is specifically used to treat inguinal hernias, which mostly occur in men. This product features a curved or cupped like design that is designed to neatly form around the patient"s groin area. The mesh is intended to provide structure and support to the areas and, to prevent additional protrusions. As of now there is no Bard 3D Max recall, however injuries are beginning to be reported across the country.
(Please see our news blog for updated Bard 3D Max recall information)
When first released, the product was constructed with full weight polypropylene fibers. This material is essentially plastic and, when implanted within the human body, is know to cause trouble. Polypropylene will shrink and harden over time causing the fibers to stiffen and break loose. Another concern is this materials unique ability to bind with tissue also allows it to bind with internal organs as well. This can eventually lead to a number of serious issues such as infection, fistulas and bowel obstruction to name a few.
Bard 3d Max Recall
While Davol has not officially issued a recall, there is an alarming, rising trend in the number of patients experiencing severe complications. Individuals are reporting these to the FDA through adverse event reports. A quick google search using the phrase "bard 3d max adverse event" will render multiple results. Here is a example in which the patient reported sever pain and burning in the pelvis area.
The 3d Max has number of fundamental issues that make it dangerous and non-suitable for long-term implantation. The first is the design itself. Creating a patch with curvature for the groin area seems like a great idea. Unfortunately the product does not hold it's shape over longer periods of time. Many reports have shown that the mesh can actually shrink and fold over on itself resulting in eventually removal through additional operations. As with most other hernia mesh products, this one is also made using polypropylene mesh. Polypropylene is a plastic material that can shrink and become brittle over time. This shrinkage is what cause the patch to fold over and sometimes break inside the body.
Another concern is with the outer sealed edge of the product. Bard considered this an innovation since previous designs left a unfinished rough edge on the patch. This new outer stitched rim supposedly allow for a smooth contact surface between the patch and internal tissues and organs. Unfortunately, this has also been considered a flaw in the product. Adverse event reports have detailed cases in which the stitched rim detaches itself leaving frayed ends. Patients have reported severe pain which is a result of internal tissue pressing against these hard plastic edges. Keeping this page and our new blog for Bard 3D Max recall updates.[See more Bard mesh products]
Bard 3d Max Injuries
Numerous reports of serious injuries from this product are beginning to roll in (Check out our news blog for the latest Bard 3d max cases and settlement amounts). The most alarming of which is migration into the spermatic cord. Some male patients have reported this serious issue which requires additional surgery to remove. To make matters worse, the testicle is sometimes also removed in order to
completely alleviate pain. Essentially the mesh attaches to the spermatic cord and becomes very difficult to remove.
Other injuries and conditions are a result of the polypropylene. As mentioned above, the 3d Max is know to shrink and fold over inside a patient. As you can imagine, the product can cause sever internal pain once it becomes rigid and deformed inside the body. Once it connects to internal tissue the problem can become even worse resulting in fistulas or serious infection as the operation site.
Bard 3D Max Settlement Amounts
While the product is not officially under recall the number of adverse event reported indicate that the FDA may take action soon. Bard has already paid out million to victims of both their Proceed and Kugel products. If you have issues, it's important to report them as soon as possible. Large medical companies like Bard have been willing to settle with victims out-of-court in past. This provides that larger payout vs class action or multi-district litigations.[Additional information on Bard mesh settlements]
Please see our news blog for updated Bard 3D Max recall information.
Published By: The Mesh Attorney
Author, creator and expert on hernia mesh related injuries, case and settlements.
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