Friday, August 10, 2012

Health Care and Pelvic Organ Prolapse

Many women suffer from a health issue known as pelvic organ prolapse--a medical condition that affects millions of women typically over the age of fifty. Counselling for the surgical treatment of pelvic organ prolapse should consider all benefits, harms, and costs of the surgical procedure, with particular emphasis on the use of mesh, according to the National Institutes for Health (NIH).

According to information submitted for this article by Jasmine McCarthy with the Public Outreach Department at DrugWatch.com, transvaginal mesh has been used to treat symptoms of Pelvic Organ Prolapse (POP) for the past decade. At first, it seemed like the perfect solution to a condition that plagues approximately 50 percent of women between the ages of 50 and 79. Unfortunately, increasing numbers of women have reported complications. For some women, these complications result in severe health problems. To date, the Food and Drug Administration (FDA) has issued two major warnings regarding the risks posed by the use of transvaginal mesh to treat POP.

What is Pelvic Organ Prolapse?

Pelvic Organ Prolapse occurs when the pelvic floor tissues and muscles begin to weaken over time. Minor weakening may not cause any problems at all. However, in moderate to severe cases, the weakened tissues allow pelvic organs to shift and drop. The organs and tissues that are usually affected by POP are the bladder, uterus and bowels. In some cases, these organs can prolapse into the vaginal canal. POP is most common in women who have experienced pregnancy and childbirth. However, menopause is also a common cause, since decreasing estrogen levels cause tissues to become thinner and weaker. Other factors that contribute to POP are smoking, obesity and a history of injury, or trauma, to the pelvis.

What is Transvaginal Mesh?

Transvaginal mesh products appeared on the market a decade ago as a solution to POP. It is used like a hammock to provide support for the pelvic floor muscles and organs, and prevents organs from collapsing into the vagina. The FDA approved most vaginal mesh products without the usual safety protocols required for new medical devices. Unfortunately, there have been thousands of cases of complications associated with vaginal mesh implants.

The FDA has issued multiple warnings to health care providers and the general population, educating people about the health risks related to the use of transvaginal mesh. Major medical companies, such as Johnson & Johnson and Bard, have pulled their mesh products from the market. In the meantime, the number of legal cases related to the damage caused by transvaginal mesh continues to rise. Women who have suffered permanent damage from surgical procedures using vaginal mesh have filed vaginal mesh lawsuits against the manufacturers.

Complications Related to Transvaginal Mesh

Vaginal mesh has a tendency to erode and/or protrude into vaginal tissues and other organs. Women can be plagued by pain, infections and discomfort during sexual intercourse. In worst-case scenarios, the mesh can puncture nearby organs, which can result in permanent incontinence. The complications are difficult to reverse, if they can be reversed at all. Most women with severe complications have to undergo multiple revision surgeries to receive any relief.

It is important that women who have had transvaginal mesh inserted to correct POP maintain regular examinations and alert health care professionals at the first signs of complications. Women who have to undergo surgery should discuss less risky alternatives with their doctor. Much more detailed information about this medical issue can be found at their website: http://www.drugwatch.com/transvaginal-mesh/pelvic-organ-prolapse.php.

According to the Chicago Tribune, mesh products first came on the market in the 1950s for use in hernia repairs. Though the FDA didn't approve the material for use in prolapse surgeries until 2002, physicians began using it "off label" for abdominal procedures in the 1970s and for vaginal procedures in the mid-'90s. The FDA considers surgical mesh to be a "Class II" medical device, posing an intermediate risk of harm to patients. With mesh products already in widespread use, the agency granted approval for their use in prolapse procedures without requiring new studies demonstrating their safety or effectiveness. Under the agency's controversial 510(k) approval process, that's permitted if devices are believed to be "substantially equivalent" to those already on the market. Here is a link to this July, 2011 article: http://articles.chicagotribune.com/2011-07-25/health/ct-nw-pelvic-prolapse-20110725_1_vaginal-wall-mesh-products-bladder .

According to the NIH, two Federal and Drug Administration warnings and an ever-increasing amount of data in medical journals reveal a paucity of support regarding routine transvaginal mesh kits for the treatment of pelvic organ prolapse. There have been no studies showing improved quality of life when compared to nonmesh repairs. There have been no studies showing superiority of mesh kits over traditional procedures for posterior or apical prolapses, and minimal data suggesting anatomic benefit of synthetic mesh for anterior compartment repairs. In contrast, transvaginal mesh use significantly increases the complication rate over nonmesh repairs. Some of these complications cause lifelong, irreversible pelvic pain, vaginal shortening, vaginal narrowing, severe vaginal pain, and dyspareunia.

Transvaginal synthetic mesh kits have minimal to no improved clinical success over nonmesh repairs, according to the NIH. Compounding this, mesh kits are clearly associated with multiple relatively common and unique complications without any significant proven benefit for symptomatic relief of pelvic organ prolapse and improvement of quality of life. Continued routine use will needlessly and potentially harm patients permanently without providing any significant benefit.

Surgery of any type involves a certain degree of risk, and this type of procedure has potentially dangerous side effects. One of the most litigous types of medical malpractice suits brought against health care professionals is attributed to issues regarding complications from POP and transvaginal mesh. Be sure to explore all options to correct problems associated with Pelvic Organ Prolapse, and if you are currently suffering from post-surgery issues, consult your doctor. If you need to seek financial relief from complications, make sure you hire reputable counsel to represent you with your case.

Until next time.

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