Faslata Allograft is a procedure that is no longer available and was previously offered by C.R. Bard, Inc. The product has been discontinued following a slew of reports of severe complications resulting from the process and from similar products. Thousands of women have reported scarring, erosion, bleeding and other serious issues as a result of this and similar products and the company has already been ordered to pay millions in compensation to those victims.
What is Faslata Allograft?
The bulk of the controversy surrounding companies like C.R. Brad is focused on their production of transvaginal mesh implants. These implants are devices that can be permanently inserted into the vagina, in a bid to provide structural support to the pelvic organs. This can then be used to combat POP (pelvic organ prolapse) as well as urinary stress incontinence.
According to the FDA, 100,000 women elected to have surgery for these conditions – and 75% of those surgeries involved vaginal mesh implants of some sort.
Faslata Allograft however is a slightly different procedure. Transvaginal mesh implants are largely made of synthetic materials such as polypropylene, an Allograft actually involves human tissue from a donor. Here, the tissue is removed from a donor’s fascia lata (hence the name, Faslata) which is a strong fibrous tissue around the thigh muscle. This is then inserted into a recipient to help support their internal tissues, reconstructing the genitourinary system or pelvic floor. The tissue used is sold in a range of sizes from 2x4cm patches, to 2x18cm slings.
Complications and Side Effects
Unfortunately, both vaginal meshes and allografts have come under significant fire due to thousands of reports of negative health effects.
Transvaginal mesh implants have been known to shrink over time with use, leading to the erosion of the vaginal walls and the internal organs. This can then lead to bleeding, perforation, scarring, pain during intercourse and serious infection.
The Faslata Allograft meanwhile has been known to completely fail, often within a year of implant. There is a 38% rate of stress urinary incontinence reoccurrence when using these products, likely due to rapid tissue degeneration. This is despite the fact that the tissue used has twice the tensile strength of the intestinal fascia removed from pigs for similar purposes. Recurrent organ prolapse is also common and often more surgery is needed.
Do You Have a Lawsuit?
With this all in mind, do you have a possible case against C.R. Bard?
If you have had a Falsata Allograft fitted and it has resulted in any discomfort or damage, or if it simply failed to work as advertising and required further surgery, then you certainly might have a case. Give us a call any time and we’ll discuss the matter with you, with no obligation.