The Transvaginal Mesh (TVM) is an implant inserted either along the vaginal or abdomen region to restrict the displacement of a female’s uterus, bladder or rectum. Physically, this surgical mesh is similar to woven fabric and is used to create a sling-like mechanism in the pelvic of bladder region to treat prolapsed issues. The TVM was also designed to reinforce the patient’s vaginal wall and is made from either polyester or polypropylene not unlike the nylon strap of a laptop bag.
The TVM is also used to treat stress urinary incontinence which often occurs in older women. In America alone, it is estimated that over 11 million women suffer from incontinence. Despite warnings published by the Food and Drugs Administration (FDA), it is also estimated that over 70,000 women had TVM surgery in the year 2011 alone.
Statistically, 40% of all adult women in America are believed to suffer from stress urinary incontinence, which is the involuntary release of urine. This phenomenon can occur for a myriad of reasons, from a cough or a sneeze to serious pelvic muscle strain caused by vaginal childbirth. Elderly women are most susceptible to this problem due to hormonal imbalance caused by menopause as well.
While most medical experts believe that stress urinary incontinence can be treated externally regardless of the quantity of urine leaked, treatments such as dietary changes, Kegel exercises, bladder retraining, biofeedback, drug therapy, pessaries and electro-stimulation is believed to only delay the final and permanent option of surgical implantation. In other words, TVM manufacturers are practically guaranteed a steady stream of patients seeking TVM surgery to permanently treat this problem.
Complications arising from the insertion of the TVM include painful intercourse, infection in the vaginal area, mesh erosion and chronic pain. Even more disturbing is the fact that a whopping 10% of patients who have had TVM insertion are the same patients who later request for the removal of the offending object within a year of having the surgery. Of this group of patients, over half of them will require further surgery to completely remove the mesh due to further complications.
To prove the hazards the TVM, a separate trial was conducted in 2009. That clinical trial resulted in 15% of the test subjects suffering from mesh erosion after only 90 days of the implant. Prior to the clinical trial, the FDA has steadily received over one thousand complains on the TVM implants. Post clinical trial, the FDA has received an additional 2,874 reports of the complications associated with the TVM surgery from 2008 until the end of 2010.
According to the FDA, the most common problem with the insertion of the TVM is that it can cause the patient’s skin to split. Besides that, problems such as infection, urinary incontinence and pelvic organ prolapsing is the second most common complain, which ironically is the reason for undergoing TVM surgery in the first place.
Other side effects of installing the TVM include:
The FDA also advises all prospective TVM patients to be both mentally and financially prepared for recurring surgical operations and frequent hospitalizations post-insertion. According to Scott Chudnoff, director of gynecology at Montefiore Medical Center in New York City, the reason why the TVM creates such drastic problems in the human body is simply because the process of inserting the mesh into one’s vagina or abdomen area is done blindly. As said surgeon cannot visualize what he or she is suturing, there is a higher likelihood of the implants damaging other organs, such as the bladder.
In the third quarter of 2011, the FDA issued a serious warning of serious complications linked to the insertion of the transvaginal mesh from nine different manufacturers. If you have had TVM surgery and are happy with your results, we advise you to continuously attend regular check-ups and follow-up visits with your healthcare provider to ensure your quality of life.
On the other hand, if you are suffering from complications or symptoms post surgery, you are advised to immediately alert your health care provider. What most people are not aware of is that they are still entitled to their rights for safe medical treatment, regardless of FDA warnings. If you are unsure of your rights, we advise you to contact Bruce Hagen, an attorney who is proficient in transvaginal mesh cases.
If your symptoms post-TVM surgery includes mesh erosion, rectum infection, pain, poor defecatory function and recurring urinary incontinence, feel free to call us today for legal advice on how you can seek medical and emotional damages. While the issue may seem trivially embarrassing, the fact that there have been 10 reported deaths between 2008 to 2010 due to transvaginal mesh follow-up surgeries highlights the seriousness of this issue. Contact Bruce Hagen to find out how you can better protect your well being today.