While the 3dMax is not officially under recall, the number of adverse event reports indicate that the FDA may take action in the future. Once it connects to internal tissue the problem can become even worse resulting in fistulas or serious infection at the operation site. As you can imagine, the product can cause severe internal pain once it becomes rigid and deformed inside the body. As mentioned above, the 3d Max is known to shrink and fold over inside a patient. Other well-known injuries and complications can result from the use of polypropylene mesh. Polypropylene Mesh has been known to cause severe groin injuries and long-term pain Essentially, the mesh attaches to the spermatic cord and becomes very difficult to remove. To make matters worse, the testicle is sometimes also removed in order to completely alleviate the pain. Some male patients have reported this serious issue which requires additional surgery to remove. Numerous reports of serious injuries from this product are continuing to accumulate. The most alarming of which is migration into the spermatic cord. Patients have reported severe pain which is a result of internal tissue pressing against these hard plastic edges. Adverse event reports have detailed cases in which the stitched rim detaches itself leaving frayed ends.
Unfortunately, this unique design has also been considered a flaw in the product.
#BARD 3D MAX MESH PATCH#
This new outer stitched rim supposedly allows for a smooth contact surface between the patch and internal tissues and organs. Bard considered this an innovation since previous designs left an unfinished rough edge on the patch. This shrinkage is what causes the patch to fold over and sometimes break inside the body.Īnother concern is with the outer sealed edge of the product. Many reports have shown that the mesh can actually shrink and fold over on itself resulting in eventual removal through additional operations.Īs 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.
Unfortunately, the product does not hold its shape over long periods of time. Creating a patch with curvature for the groin area seems like a great idea. The 3d Max has a number of fundamental issues that make it dangerous and non-suitable for long-term implantation.
Here is an example in which the patient reported severe pain and burning in the pelvis area. Individuals are reporting these to the FDA through adverse event reports.Ī quick google search using the phrase “bard 3d max adverse event” will turn up many results. While Davol has not officially issued a recall, there is an alarming and rising trend in the number of patients experiencing severe complications. Bard 3d Max Adverse Events and Possible Recall This can lead to a number of serious injuries such as infection, fistulas, and bowel obstruction to name a few. Polypropylene will shrink and harden over time causing the fibers to stiffen and break loose.Īnother concern is this material’s unique ability to bind with human tissue, which unfortunately also allows it to bind with internal organs. This material is essentially plastic and when implanted in the human body is known to cause significant issues.
#BARD 3D MAX MESH FULL#
When first released, the Bard 3DMax was constructed with full weight polypropylene fibers.
The Bard 3dMax mesh is made with Polypropylene, a plastic-like material
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