Transvaginal Mesh Now Considered a High-Risk Device
New medications and medical devices are constantly being introduced into the market. Laboratory tests and clinical trials often last for months, years, and even decades before the new products are deemed to be safe for human use. No matter how ‘safe’ a solution is said to be, however, there are always side effects that are possible. Every individual reacts to treatment differently, and it is the responsibility of the drug manufacturers to determine potential risks and disclose them to the public before use. Occasionally, problems will arise that were not foreseen during initial testing, and, unfortunately, the public is left with more suffering than positive results. Such seems to be the case for a product known as transvaginal mesh, leading the U.S. Food and Drug Administration (FDA) to label the product as a high-risk device.
What Is Transvaginal Mesh?
Transvaginal mesh was created to treat women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two side effects common with hysterectomies, menopause, and childbirth. Pelvic Organ Prolapse occurs when the pelvic floor is weakened and the organs (bladder, rectum, and uterus) drop down into the vagina. The device is typically made of a special plastic known as polypropylene. It is a surgical mesh that implanted either abdominally or transvaginally, the latter of which is often easier to implant. For prolapse, the mesh is implanted in order to reinforce the pelvic floor. For incontinence, the mesh is used as a bladder sling that cradles the bladder for added support.
The Dangers
On October 20, 2008, the FDA first released a notification that there were a high number of adverse effects reported. At that point, there were simply over 1,000 patients with adverse effects. That number grew exponentially as soon as the information was released. Now the number of people actively seeking compensation from the adverse effects through litigation totals more than 75,000 women. Some of the side effects mentioned include:
- Erosion. This is the most common and the most device specific as if it is not implanted correctly, the device can move and puncture the vaginal wall and even other organs. This results in further complications as often requires other surgeries to have it removed;
- Severe pelvic, genital, or groin pain;
- Recurrence of prolapse or incontinence;
- Nerve damage;
- Fistulas;
- Vaginal scarring;
- Infection, including urinary tract infections (UTIs);
- Neuro-muscular problems;
- Autoimmune problems;
- Vaginal shrinkage or shortening;
- Vaginal bleeding; and
- Blood in the stool or urine.
Who Is Responsible?
If you are experiencing any of the above complications, you may be wondering who is at fault. Each case depends on who knew what and when they knew it. If the doctor or physician was given the information about the potential side effects but did not pass it on to you and assured you that you had nothing to worry about, then your doctor may be the one liable. Of course, many of these devices were implanted prior to the knowledge of how frequently and severely the side effects were occurring. In these cases, liability fault may rest squarely on the drug manufacturers for not disclosing all of the potential risks.
If you have been treated with transvaginal mesh and have experienced any of the listed side effects or any other complications, do not hesitate to seek help. This especially important if you have lost wages or have had a decline in your standard of living in any way for a prolonged period of time. If you live in the greater Chicago area and would like to discuss your legal options, contact an experienced Kane County personal injury attorney. Call 630-907-0909 for a free consultation today.
Sources:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
https://www.drugwatch.com/transvaginal-mesh/
http://www.medscape.com/viewarticle/856714
