By Mark T. Sadaka, MSPH, Esq.
In October 2008 the FDA warned consumers and health care providers about the dangers of surgically implanted plastic mesh used to support a weak vaginal wall. This type of mesh is called vaginal mesh. Many women have yet to come forward and probably never will because of the severe and embarrassing nature of the injuries associated with these products. This makes injuries caused by vaginal mesh truly a private problem.
Plastic: Not Just for Storing Leftovers
Using implanting plastic devices during surgery is a common practice. Plastic used to close holes or provide support for weak spots in the body is commonly referred to as surgical mesh. Surgical mesh is used in a many areas throughout the body including the vaginal wall.
Taking a cue from eastern philosophy, surgical mesh’s ultimate goal is to become one with the body. In medical terms, surgical mesh needs to integrate into the tissue which surrounds it to be truly effective. Vaginal mesh is no different. Research has shown that mesh integration is best when the plastic has large pore size and is lightweight.
Like a fishnet, surgical mesh is full of holes. These “holes”, known as pores, allow tissue to hook on. All surgical meshes have pores; some are large and some are small. It is widely thought that material with large pores increases tissue integration.1 Not only does the selection of material effect pore size, but it also effects the “weight”. Surgical mesh material comes in both heavyweight and lightweight. Heavyweight material is thought to be stronger than lightweight material but it is associated with a larger inflammatory response.2
Whenever a foreign substance is placed in the body, the body’s immune system will react to it by triggering an inflammatory immune response. A larger inflammatory response is thought to be associated with decreased healing and integration, and increased incidence of complications.3 It is thought that heavyweight material is most appropriate for use in hernia repairs and not for the vaginal wall.
The actual relationship between pore size, weight of material and the incidence of complications is beyond the scope of this paper. However, in brief summary, the ideal surgical mesh would have a large enough pore size to encourage integration with tissue while causing a low inflammatory response.4
Vaginal mesh is used to support weakened areas of the pelvic region. As women grow older or have children the walls of their pelvic region can become weak. When the walls are weak, organs like the bladder may drop and push against the wall of the vagina. This condition is called pelvic organ prolapse. Vaginal mesh is also used to treat leakage of urine during moments of stress otherwise known as stress urinary incontinence (SUI).
The Treatment of Pelvic Organ Prolapse
The front and the back walls of the vagina can become weak. When the front wall of the vagina is weak the bladder may sink into the vagina. This condition is called cystocele.5 Also the urethra may sink into the vagina. This condition is called urethrocele.6 When either of these conditions occur a woman may not be able to empty her bladder completely, leak urine, and increase the risk of bladder infections.7
When the back walls of the vagina become weak the area of the lower intestine that stores feces may bulge into the vagina.8 This condition is called rectocele.9
The Treatment of Stress Urinary Incontinence
Most women that undergo surgery with vaginal mesh first present to the doctor with some sort of urinary incontinence. Vaginal mesh is indicated only for the treatment of stress urinary incontinence.10 The hallmark sign of stress urinary incontinence is a leakage of urine while coughing, laughing or sneezing.11 This condition can occur as a result of pelvic organ prolapse.12 However, women suffer from a many different types of incontinence that may be confused with SUI.
Urge incontinence occurs when the person looses urine for no apparent reason after suddenly feeling the need to urinate.13 Overactive bladder occurs when the nerves tell the bladder to squeeze at the wrong time.14 Overflow incontinence happens when the bladder doesn’t empty all the way.15 It suffices to say that a lot of women undergo the implantation with vaginal mesh to treat the wrong type of incontinence.
The Problem: Its Plastic After-all
In October 2008 the FDA’s warning about vaginal mesh included reports of erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.16
Lack of integration and a large inflammatory response can cause breakdown of the surrounding tissue. This breakdown is called erosion. As you may imagine, the breakdown of tissue in a delicate area causes tremendous discomfort, pain and scarring, including the presence of the mesh outside of the vagina.17 This process can lead to severe infections, damage to the organs like the bladder and the intestine, and the inability of some women to engage in sexual activity due to the pain.18 The only treatment for erosion is additional surgery to remove the mesh. However, in most cases, not all of the mesh can be removed because it has integrated into the tissue.19 Therefore, further removal of the mesh would inflict more damage.
Insult to Injury: It Doesn’t Work
The FDA’s October 2008 announcement included a recurrence of the prolapse and/or incontinence as a complication of the procedure. So not only to women incur a risk of erosion and organ damage when undergoing vaginal mesh placement, it appears that the mesh doesn’t work. The FDA stated that recurrence of the prolapse and/or incontinence was a complication of the surgery.20
The Usual Suspects: The Biggest Players in the Vaginal Mesh Market
C.R. Bard, Ethicon (a subsidiary of Johnson & Johnson), and American Medical Systems.