Bard 3DMax Lawsuit
The 3Dmax hernia mesh lawsuit is against Bard and its subsidiary Davol Inc. The 3DMax inguinal hernia repairs. Inguinal hernia’s are located in the groin and occur most frequently in men. The 3DMax hernia mesh has caused thousands to suffer chronic, debilitating pain. The 3DMax also frequently erodes into the spermatic cord in men, which attaches to the testes. Men are frequently reporting sexual dysfunction associated with the 3DMax hernia mesh. Removing the 3DMAx can cause additional problems, such as necessitating the removal of a testicle. Bard came out with the 3DMax light in 2009, which uses light-weight polypropylene. Because polypropylene causes so many complications, many manufacturers tried to use less polypropylene (lighter weight) in hopes of reducing complications. Unfortunately, both heavy-weight and light-weight polypropylene hernia mesh are problematic. We are currently building the 3DMax page, bookmark this page and check back in soon for even more information.
3DMax: A Defectively Designed Hernia Mesh
Outer Sealed Edge and Polypropylene Prone to Tearing
Bard touts its 3DMax hernia mesh as having a sealed outer edge. The purpose of the 3DMax’s sealed outer edge is to prevent the rough edges of the polypropylene from cutting into a patients tissue. The 3DMax’s sealed outer edge also helps hold the entire hernia mesh together, without the sealed edge the 3DMax beings to fray and tear. Many surgeons have reported the outer sealed edge of the 3DMax to already be torn when they opened the package. Other surgeons have reported the outer sealed edge of the 3DMax tearing while implanting the hernia mesh. Both the heavy-weight 3DMax and the 3DMax light are prone to tearing.
Is the FDA Aware that the Bard 3DMax’s Outer Sealed Edge is Prone to Tearing?
- Apr 2017: 3DMax Light FDA Adverse Event Report MDR 6483016 “The surgeon noted torn mesh on the bottom edge of the device in two locations.”
- Sept 2016: 3DMax FDA Adverse Event Report MDR 5936616 “Mesh was found to be damaged out of the package.” “The evaluation find for tears/ frays along the edge seal of the device. Also noted are two areas of torn mesh both close to the edge of the device.”
- Aug 2016: 3DMax Light FDA Adverse Event Report MDR 5893826 “When the 3dmax light mesh was being rolled the surgeon noted that there was a tear along the edge of the mesh.”
- Jul 2016: 3DMax FDA Adverse Event Report MDR 5789742 “It was noted that the normally smooth edge of the mesh was ripping and becoming a jagged edge.”
- Dec 2015:3DMax Light FDA Adverse Event Report 5274515 “The edge of the mesh was torn.”
- Oct 2015: 3DMax FDA Adverse Event Report MDR 5116230 “the right sided 3dmax mesh tore while attempting to introduce into the body.”
- Jul 2015: 3DMax Light FDA Adverse Event Report MDR 4950253 “The mesh was rolled using a grasper and inserted through a 10mm port. When the mesh was unrolled inside the body cavity the surgeon noted the mesh was torn and damaged in placement.”
- Jun 2015: 3DMax Light FDA Adverse Event Report MDR 4828248 “There was a tear noted in the corner perimeter of the mesh after removal from the package.”
- Sept 2011: 3DMax FDA Adverse Event Report MDR 2991778 “Operating room staff opened product to use on a surgical case and alleged mesh to have several tears.”
Prone to Folding Over on Itself and Migrating
Most hernia mesh products are flat meshes. The 3DMax is a curved cup that claims to be fitted for the inguinal canal. Like many other hernia meshes, the 3DMax is made of polypropylene. Over time the polypropylene degrades and shrinks. When the 3DMax shrinks, it commonly folds on top of itself due to its curved design. The Hollis Law Firm’s hernia mesh lawyers have identified a unique type of mesh failure in the 3DMax.
Is the FDA Aware that the Bard 3DMax is Prone to Folding Over on Itself and Migrating?
- Aug 2016: 3DMax FDA Adverse Event Report MDR 5878217 “Mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom”
- Nov 2015: 3DMax FDA Adverse Event Report MDR 5254204 “When removed, no hernia was found and the mesh was folded in half. He seemed to have had some type of body reaction to the mesh or the mesh was defective and may have had some toxic chemical that did not belong on or in it because he got so ill.”
- Jun 2015: 3DMax FDA Adverse Event Report MDR 4827970 “Mesh was not secured in place and had migrated from the groin area to the abdomen and would need to be removed.”
- Aug 2014: 3DMax FDA Adverse Event Report MDR 3998860 “her surgeon states her chronic abdominal pain is due to shrinkage of the mesh.”
- Jan 2014: 3DMax FDA Adverse Event Report MDR 3610860 “there was suspicion that mesh migration and shrinkage was the cause of recurrence.”
- Oct 2013: 3DMax FDA Adverse Event Report MDR 3471951 “The mesh repair was not flat and should be flat.”
- Aug 2012: 3DMax FDA Adverse Event Report MDR 2727506 During a revision surgery the surgeon had to remove “some tacks to relieve tension” and he had to re-flatten the mesh.
- Mar 2012: 3DMax FDA Adverse Event Report MDR 2508452 The mesh migrated to “the midline, right on top of the bladder.”
- Feb 2012: 3DMax FDA Adverse Event Report MDR 2471948 “MD noted the mesh had buckled, the mesh was explanted. Currently, the patient reports she is still in a lot of pain and has nerve damage in the left inguinal area.”
- Oct 2009: 3DMax FDA Adverse Event Report MDR 1519799 The hernia mesh “shifted.”
- Mar 2009: 3DMax FDA Adverse Event Report MDR 1342998 Five months after implantation the surgeon noted “it appeared as if the right hernia mesh had folded in its midsection and no longer covered the hernia defect.
- Nov 2007: 3DMax FDA Adverse Event Report MDR 955537 “The mesh folded over and has been causing severe pain where the mesh is located.”
3DMax: Dangerous Materials
In addition the the defective design of the 3DMax, it utilizes a cheap plastic called polypropylene. Once implanted polypropylene begins to degrade. As polypropylene degrades it cracks, pieces break off, and it starts to shrink. Polypropylene can also erode through soft tissue and damage nearby nerves. If the polypropylene erodes through enough tissue, it will eventually attach to the spermatic cord in men. A highly skilled surgeon can carefully dissect the 3DMax from the spermatic cord if it is treated early. Eventually, the 3DMax max will erode into and through the spermatic cord. If the damage to the spermatic cord is too great, the testicle will also have to be removed. The pain caused by the 3DMax is so severe and debilitating that thousands of men have opted to have their testicle removed to alleviate the pain.
Contact our hernia mesh lawyers for a free 3DMax case evaluation. An attorney and a medical professional will look over your case and let you know what they believe the best course of action is for you. The Hollis Law Firm does not handle class actions. Each claim is an individual lawsuit. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. The Hollis Law Firm represents clients and files lawsuits nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call 1-800-701-3672 for a 3DMax hernia mesh lawsuit evaluation.
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