Lawyers Investigating Bard Pelvisoft & Pelvicol Mesh Injuries

Surgical mesh injury lawyers are investigating complaints about Bard's Pelvisoft and Pelvicol and would like to talk with you if you've been injured. Here's a bit more on the products and the injuries being reported by women around the country.

Pelvisoft & Pelvicol : What Are They?

C.R. Bard manufactures several transvaginal mesh products such as Avaulta Plus BioSynthetic Support System, Avaulta Solo Synthetic Support System, Faslata Allograft, Pelvicol Tissue, PelviSoft Biomesh, Pelvitex and Polypropylene Mesh. Two of these, Pelvisoft and Pelvicol, have come under scrutiny as vaginal mesh injury lawyers have identified evidence of negligence and serious medical complications. So, what are these products?

  • Pelvisoft. Pelvisoft, also known as Acellular Collagen BioMesh, is being marketed as a medical device as a natural long-term implant that augments the effectiveness of site-specific defect repair in pelvic reconstruction - which is supposed to deliver all the performance benefits of natural tissue together with the porosity of synthetic mesh in a single implant for use in pelvic floor reconstruction.

  • Pelvicol. Pelvicol, also known as Acellular Collagen Matrix, is being marketed as a permanent natural implant in pelvic floor reconstruction, pubovaginal slings and urological repairs that is supposed to be permanent, natural, strong and safe.

While investigations concerning negligence and what types of clinical trials were conducted prior to the products being released into the marketplace are still ongoing, evidence of serious medical complications surrounding transvaginal mesh products, in general, are well documented.

Pelvisoft & Pelvicol Mesh Injuries

The vagina and its surrounding structures (bladder, rectum, etc.) are attached to the pelvis by connective tissues. These tissues help form walls around the vagina and ensure that normal urination and bowel movements can occur. However, if pelvic muscles become weak, then connective tissues can fail and cause pelvic structures like the bladder or rectum to bulge into the vaginal wall. This can cause the following symptoms:

  • A feeling of vaginal fullness, heaviness, or even pain;

  • Difficulty with bowel movements;

  • Involuntary urination or inconsistent urinary stream - stress urinary incontinence (SUI);

  • Loss of bladder control;

  • Pain or discomfort during intercourse;

  • (pelvic organ prolapse);

  • Recurrent urinary infections;

In order to correct these issues, manufacturers came out with transvaginal mesh products that were supposed to work better than traditional surgical procedures. However, that has not been the case for many women who have contacted the U.S. Food & Drug Administration (FDA) and filed product liability lawsuits against manufacturers such as Bard, Gynecare, Tyco Covidien, Mentor OB, Ethicon, AMS and Boston Scientific. In fact, the FDA had this to say about transvaginal pelvic mesh complaints:

The most frequent complications include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

These are serious side effects and many injured victims have said that they would not have had the procedure done had they known about the risks involved - something for which they allege manufacturers simply haven't been forthcoming.

50% of Mothers May Experience POP

It is estimated that half of all women who have delivered a child will suffer from some form of POP. Vaginal mesh injury lawyers say that problems due to Pelvisoft, Pelvicol and other transvaginal mesh products have been grossly under reported as many women believe that their injury was simply individual and that there is not a common association amongst many users. However, now that more and more victims are coming forward, that does not seem to be the case.

There are some mesh injury attorneys who speculate that transvaginal mesh manufacturers may be experimenting with different forms of synthetic materials and are using patients as "guinea pigs" instead of conducting the types of clinical trials that most of us assume would occur before these products were so commonly used. Whether that's true or not remains to be seen, but one thing is clear - thousands of women are reporting transvaginal mesh side effects and injuries. If you're one of them, it's important to know that you're not alone and that you can take action.