Bard Mesh Recalls - 2018
The Bard Medical corporation has been manufacturing the 3DMax ™ as early as 2007 through it's subsidiary company Davol. The 3D Max is specifically used to treat inguinal hernias, which mostly occur in men. The 3D Max 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 the number of injuries being reported across the country continues to grow.
When first released, the product was constructed with full weight polypropylene fibers. This material is essentially plastic and when implanted in 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 turn up many results. Here is a example in which the patient reported severe 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 eventual 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 causes 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 an unfinished rough edge on the patch. This new outer stitched rim supposedly allows 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.
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Bard 3d Max Injuries
Numerous reports of serious injuries from this product are continuing to accumulate (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 the pain. Essentially, the mesh attaches to the spermatic cord and becomes very difficult to remove.
Other injuries and conditions also result from the use of polypropylene mesh. As mentioned above, the 3d Max is known to shrink and fold over inside a patient. As you can imagine, the product can cause severe 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 at the operation site.
Bard 3D Max Settlement Amounts
While the product is not officially under recall, the number of adverse event reports indicate that the FDA may take action in the future. Bard has already paid out million to victims of both their Proceed and Kugel mesh products.
If you are currently suffering from a hernia mesh implant, it's important to seek advice on your legal right to compensation as soon as possible. Large medical device companies like Bard have been willing to settle with victims of hernia mesh injuries. All legal claims have deadlines, so don't delay. You can contact us now for a free, no obligation consult.[Additional information on Bard mesh settlements]
Published By: The Mesh Attorney
Author, creator and expert on hernia mesh related injuries, case and settlements.
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