Though major manufacturers have discontinued sales of their mesh based products during the past decade or so, an industry-wide transvaginal mesh recall has yet to come about.
FDA Warns Against Vaginal Mesh Procedures
Mounting evidence and complaints made by patients that had transvaginal procedures performed on them has prompted the Food and Drug Administration (FDA) to issue a series of warnings since 2008. These have strongly highlighted the high risk of complications and injuries arising due to the surgical mesh implantation.
Structure and Purpose of a Vaginal Mesh
As the name implies, a vaginal mesh is made out of either absorbent natural materials or porous absorbent or non-absorbent synthetic fibers. These artificial fibers can be derived from polypropylene/plastic, polyester or even stainless steel and are woven together to create the final product.
The vaginal mesh was initially developed during the 1950s to treat abdominal hernias. The mesh was used to cover a hole in the abdominal wall so as to prevent the intestines and other organs from protruding out through the opening. However, as the use of the surgical mesh became widespread, doctors soon realized that they could also use it for the treatment of stress urinary incontinence (SUI) n and pelvic organ prolapse (POP). Here it is interesting to note that surgeons started using these mesh products almost three decades before the FDA officially approved of their usage for POP procedures in 2002. The manufacturers ramped up production and started rolling out mesh products that were particularly marketed for POP and SUI treatment.
Disorders Associated with Vaginal Mesh
SUI involves the uncontrollable release of urine caused by physical stress during activities such as sneezing, exercise, coughing and even laughing. POP on the other hand is the bulging or lowering of the internal organs above the vagina, which in some cases extends beyond the vagina’s opening.
A Need for Vaginal Mesh Recall
Typically, the surgical mesh is implanted so as to give additional support to a weakened vaginal wall to hold back the organs in POP and give more control over the urethra in preventing involuntary urine release in SUI. The problem however arises when these mesh products give rise to dire complications of their own rather than being the cure they were intended to be.
According to the FDA, they received hundreds of reports from women who had undergone vaginal mesh implantation procedures stating they experienced a range of side effects. These frequently included crumbling of the mesh implant in the surrounding vaginal tissue, pain during sexual intercourse, more urinary problems that included a return of urinary incontinence and an increased risk of organ prolapse.
By 2011, the number of cases reporting severe problems and injurious complications from mesh implants climbed to almost 4,000. This prompted the chief scientist and deputy director of the Center for Devices and Radiological Health at the FDA, William Maisel to say that there were clear risks associated with the transvaginal placement of mesh to treat POP. Manufacturer Ethicon, a subsidiary of Johnson & Johnson, was sued by over 600 women that received their implant. However, to date, there has not been an official announcement by the FDA for any sort of a surgical mesh recall.
FDA Warns Against Vaginal Mesh Procedures
Mounting evidence and complaints made by patients that had transvaginal procedures performed on them has prompted the Food and Drug Administration (FDA) to issue a series of warnings since 2008. These have strongly highlighted the high risk of complications and injuries arising due to the surgical mesh implantation.
Structure and Purpose of a Vaginal Mesh
As the name implies, a vaginal mesh is made out of either absorbent natural materials or porous absorbent or non-absorbent synthetic fibers. These artificial fibers can be derived from polypropylene/plastic, polyester or even stainless steel and are woven together to create the final product.
The vaginal mesh was initially developed during the 1950s to treat abdominal hernias. The mesh was used to cover a hole in the abdominal wall so as to prevent the intestines and other organs from protruding out through the opening. However, as the use of the surgical mesh became widespread, doctors soon realized that they could also use it for the treatment of stress urinary incontinence (SUI) n and pelvic organ prolapse (POP). Here it is interesting to note that surgeons started using these mesh products almost three decades before the FDA officially approved of their usage for POP procedures in 2002. The manufacturers ramped up production and started rolling out mesh products that were particularly marketed for POP and SUI treatment.
Disorders Associated with Vaginal Mesh
SUI involves the uncontrollable release of urine caused by physical stress during activities such as sneezing, exercise, coughing and even laughing. POP on the other hand is the bulging or lowering of the internal organs above the vagina, which in some cases extends beyond the vagina’s opening.
A Need for Vaginal Mesh Recall
Typically, the surgical mesh is implanted so as to give additional support to a weakened vaginal wall to hold back the organs in POP and give more control over the urethra in preventing involuntary urine release in SUI. The problem however arises when these mesh products give rise to dire complications of their own rather than being the cure they were intended to be.
According to the FDA, they received hundreds of reports from women who had undergone vaginal mesh implantation procedures stating they experienced a range of side effects. These frequently included crumbling of the mesh implant in the surrounding vaginal tissue, pain during sexual intercourse, more urinary problems that included a return of urinary incontinence and an increased risk of organ prolapse.
By 2011, the number of cases reporting severe problems and injurious complications from mesh implants climbed to almost 4,000. This prompted the chief scientist and deputy director of the Center for Devices and Radiological Health at the FDA, William Maisel to say that there were clear risks associated with the transvaginal placement of mesh to treat POP. Manufacturer Ethicon, a subsidiary of Johnson & Johnson, was sued by over 600 women that received their implant. However, to date, there has not been an official announcement by the FDA for any sort of a surgical mesh recall.