Pelvisoft Biomesh is one of many products designed by Bard Medical with the intention of treating pelvic organ prolapse and stress urinary incontinence. Specifically, Pelvisoft Biomesh is the name of a particular material, that is used across a wide number of mesh implants.
Unfortunately however, it is also one of many such products to have come under fire and to have become the subject of many lawsuits, following reports that its use can lead to injury, infection and other difficulties.
If you have suffered any side effects from a Bard Medical mesh implant, then you should consider getting a transvaginal mesh attorney to represent you. Women are now winning lawsuits against Bard and other vaginal mesh manufacturers, with some payouts being in the millions.
To find out more about Pelvisoft Biomesh and the dangers that it poses to women’s health, read on.
What is a Vaginal Mesh Implant?
Transvaginal mesh implants are designed to treat pelvic organ prolapse (POP) as well as stress urinary incontinence. These are highly common issues that affect hundreds of thousands of women around the world; and transvaginal meshes are one of the main forms of treatment/management.
Essentially, the role of a transvaginal mesh implant is to provide structural support for the prolapsing organs, acting like a net or a ‘sling’ to hold them in place. These meshes can be made from a host of materials, including Pelvisoft Biomesh.
The FDA notes that in 2010, over 100,000 US citizens underwent surgery for the condition, with transvaginal meshes being used in the procedure 75% of the time.
Complaints and Effects
Between 2008 and 2010, the FDA stated that they received over 1,500 complaints of adverse effects resulting from the use of transvaginal mesh implants. These reports included extensive bleeding, infection, erosion, vaginal mesh protruding into the vagina, permanent scarring, organ perforation, pain during intercourse and more. Many high profile lawsuits followed as companies hurried to cease production of the units – too late for many women. Among these lawsuits were several levelled at devices created with Pelvisoft Biomesh.
Many of these products appear to shrink over time, which causes them to become damaging and to start eroding the walls of the vagina and the organs they are designed to protect. The prevalence of these problems suggest that the devices were not adequately tested prior to release – in fact the FDA did not require transvaginal mesh manufacturers to perform studies on humans at all. As long as the manufacturer of a product can point to similar products on the market, they also don’t need careful scrutiny to gain approval. In this case, the ‘similar product’ happened to be the ProtoGen Sling, which was also recalled from market in 1999 due to ‘higher than expected rate[s] of vaginal erosion’.
If you have suffered any ill effects from these products, you should consider hiring a transvaginal mesh attorney. We are highly familiar with the complex and troubling issues surrounding vaginal mesh implants and have helped many women to obtain the compensation they deserve. If you are among the thousands who has suffered as a result of Bard Medical, get in touch and we may be able to help you as well.