It is unacceptable when a medical procedure intended to make a patient feel much better goes bad and causes additional pain and discomfort. It's even worse if the medical procedure causes serious, permanent debilitating injury or loss of life.
A good example is recent problems experienced with vaginal mesh, a good medical tool intended to restore a normal life to women who have been suffering but sometimes results in their quality of life worsening.
Vaginal mesh has been commonly used by doctors for women suffering from pelvic organ prolapse where a woman's uterus, bladder or rectum slips out of place. A common treatment has been to implant vaginal mesh to strengthen vaginal or other tissue that has weakened, usually after childbirth.
Surgical mesh, generally used to repair weakened or damaged tissue, is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse and stress urinary incontinence. It is permanently implanted to reinforce the weakened vaginal wall for Pelvic Organ Prolapse (POP) repair or support the urethra or bladder neck for the repair of Stress Urinary Incontinence (SUI).
About 100,000 women were treated or pelvic organ prolapse with surgical mesh in 2010, with 75,000 of those implanted vaginally. The FDA for the first time began sending warnings to doctors, citing more than 1,000 manufacturer reports of complaints from 2005-2007. Since then the number of complaints regarding vaginal mesh has increased five times. Most of the complications involve erosion where the skin breaks and the device protrudes or contraction of the mesh that results in vaginal shrinkage.
There are new treatments for pelvic organ prolapse that can be corrected in one day minimally invasive with minimal recovery times. Dr. Adeeti Gupta, MD and OBGN of Flushing, NY, uses this treatment because women suffering from prolapse face enough problems without having risking mesh implants that can worsen their lives.
"Urine incontinence and pelvic organ prolapse is a very prevalent and distressing condition in women," says Dr. Gupta. "But because of the fear of guilt and shame, women are afraid to come out in the open with these problems. I can help these women, and it is very gratifying to be able to improve their quality of life."
Events regarding use of vaginal mesh have escalated rapidly since 2010. In 2012 the FDA ordered transvaginal manufacturers to study the risks involved after receiving more than 3,800 reports in 2011 of complications related to vaginal mesh. As a result manufacturers are required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for pelvic organ prolapse and single-incision mini-sling devices for incontinence issues. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.
Some of the dangerous side effects of vaginal mesh include
• Erosion of the vaginal epithelium • Bladder of bowel perforation • Serious infection • Return of Pelvic Organ Prolapse • Urinary Incontinence • Additional Surgery
Because of the growing reports of complications, there has been a marked increase in lawsuits filed against manufacturers - as of May 2012, 335 against AMS, 268 against Johnson & Johnson's Ethicon division, 205 against Boston Scientific and 645 lawsuits filed against C.R. Bard.
In March 2012 Bloomberg News reported that Johnson & Johnson sold vaginal mesh implants for three years before was approved for use by the FDA.
Because of these developments, any woman who has had a vaginal mesh implant should make an appointment with the physician who performed the implant for an examination and to learn from the doctor which manufacturer made the device. After having all their medical questions answered, afflicted women should then talk with a knowledgeable attorney about what actions, if any, should be taken.
To succeed in a medical malpractice lawsuit the patient's well-being has to be made worse because of a treatment or procedure, the worsened condition has to be the result of negligence, and it certainly helps when there has been a willful decision to continue after warnings have been issued.
Manufacturers will and have ignored warnings and cautions from the FDA but they do listen closely to their attorneys when advised of the filing of medical malpractice lawsuits. Any woman who has been harmed by a vaginal implant should consider legal action as a means to stop manufacturers continuing business practices that will harm other women. Victims of vaginal implants should also consider legal action as a means of getting the justice they so much deserve.
So my best advice to vaginal mesh implant victims is to first consult your physician and then consult an attorney who specializes in medical equipment malfunctioning. This is the very best way to make a painful situation better and find a remedy for women who become victims because of the greed and carelessness of people and companies they should be able to trust.
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