(October 6, 2011) Vaginal mesh repair is a popular procedure done after the pelvic muscles become weak, often as a result of childbirth, menopause or hysterectomy. The pelvic muscles and supporting tissues can no longer support the bladder, urethra, uterus, or bowel. This causes these organs to drop and bulge into the vagina also known as pelvicorgan prolapse (POP), causing leakage of urine during physical exercise, sneezing or laughing.
Many physicians use this vaginal mesh as a cradle or sling to hold the organs up and keep them in place. This repair is a surgical technique using a synthetic mesh (polypropylene) to anchor or reinforce the weak tissues that support the pelvic organs or to provide bladder support to reduce or eliminate urinary leakage. Thousands of women have experienced serious complications from the vaginal mesh. Complications reported from the vaginal mesh procedure are: erosion of the mesh, infection, very painful intercourse, urinary problems, bleeding, severe discomfort, vaginal scarring, bowel perforation, hardening of the mesh, risk of organ perforation during surgery, recurrence of POP, recurrence of urinary stress incontinence and need for additional surgeries. This mesh has not been tested or approved prior to its implementation and has caused many serious life-changing complications to thousands of women. Many are unable to sit and report that they can no longer have sexual intercourse or use tampons. Some say that they were better off before the mesh was implanted and would prefer to go back to the way they were before the surgery.
Hundreds of lawsuits havebeen filed against the manufacturers (Johnson & Johnson and CR Bard Inc.). Last year more than 100,000 vaginal mesh procedures have been performed (about 75% done trans-vaginally). Most medical devices are not required by the FDA to prove their safety and effectiveness before being approved. There were 2,874 complications received by the FDA between January 2008 and December 2010.
On August 25, 2011 PDF (consumer advocacy group) filed a petition with the FDA to issue a recall and ban marketing to protect consumers. The FDA is discussing whether the vaginal mesh products should be re-classified as a Class III medical device. Although the device may not be recalled, manufacturers will be required to test their safety before obtaining approval to continue using these products.
It is horrendous that these manufacturers do not spend the money to test these devices before ruining the lives of so many women. Their negligence entitles these suffering women to compensation, as many of their lives will never be the same. If you or a loved one have experienced adverse reactions following the placement of vaginal mesh, you may be entitled to compensation for medical bills, lost wages, pain andsuffering and other damages. Please feel free to comment on our Facebook page or Retweet this article.