Pelvic Organ Prolapse/Stress Urinary Incontinence
Pelvic organ prolapse and stress urinary incontinence are two medical conditions that women can develop as they age. Both conditions are more likely to occur in women who have given birth to children. Both were routinely treated by the use of transvaginal mesh products in recent years, and unfortunately many women who underwent this type of treatment have now begun to develop serious complications.
If you or a loved one has been diagnosed with pelvic organ prolapse (POP) or stress urinary incontinence (SUI), it is very important that you carefully evaluate your treatment options. If you have already had a procedure and are using transvaginal mesh, then you need to understand your legal rights. A Boston transvaginal mesh attorney at the Law Office of Jeffrey S. Glassman can provide you with more information on taking legal action.Understanding POP/SUI
Pelvic organ prolapse and stress urinary incontinence are related medical conditions because both involve weakening of muscles caused by age and exacerbated by childbirth.
Pelvic organ prolapse is a condition that occurs when the pelvic muscles weaken and no longer provide sufficient support to keep the organs in the pelvis in place. The organs in the pelvic area, including the bladder, urethra, uterus and small bowel, can start to drop and press on the vagina. This can cause significant discomfort.
Stress urinary incontinence occurs when the muscles that support the bladder or urethra weaken. As a result of the loss of muscle control, women begin to have problems regulating their flow of urine. As a result, women who sneeze, cough, laugh or do physical activity may urinate involuntarily. This can be annoying and embarrassing.Transvaginal Mesh as a Treatment Method
There are a variety of treatment options for POP and SUI, but in the mid-2000’s, the use of transvaginal mesh products came into favor. Many manufacturers began to release transvaginal mesh products, including a subsidiary of Johnson & Johnson called Ethicon. These manufacturers were able to fast-track the approval of transvaginal mesh products under the FDA’s 501(K) rules.
The FDA will approve medical devices more quickly and without rigorous testing if the devices are substantially similar to past medical products that have already been approved. This is true even if there have been known problems with the past medical product that is providing the basis for the approval, as long as no involuntary FDA recall occurred. Because surgical mesh products substantially similar to transvaginal mesh already existed, the FDA allowed these products to come into widespread use even without rigorous safety testing in place to ensure the products worked and weren’t dangerous.
Unfortunately, complications began to arise almost immediately and thousands of women made complaints to the FDA about dangerous side effects they were experiencing from Transvaginal mesh. This led to a various actions on the part of the FDA including warnings issued in October 2008 and in 2011. Business Week also reported on an FDA order in January of 2012 mandating that 31 different manufacturers of transvaginal mesh products conduct rigorous scientific studies.
While the FDA rule may have contributed to the problem, however, it is ultimately the responsibility of the manufacturer to test their medical devices and to not release dangerous products on the market. It is the manufacturer who has to pay when something goes wrong.Taking Legal Action
The FDA has made clear that there is no substantial benefit to using transvaginal mesh products to treat POP or SUI over other treatment methods, and unfortunately there is a substantial risk. As such, if you are suffering from pelvic organ prolapse or stress urinary incontinence, you should explore other treatment alternatives and study carefully the side effects of mesh products if they are suggested as a treatment method. Although Ethicon has stopped selling most mesh products in the face of numerous lawsuits, there are still some mesh products available and in use today, so be very careful in making a treatment choice.
If you have already used transvaginal mesh products as a method of treatment for pelvic organ prolapse or stress urinary incontinence, then you may have a claim against the device manufacturer. To learn more about your legal rights or for help obtaining fair and reasonable compensation from the manufacturer of the dangerous medical device that hurt you, contact the Law Office of Jeffrey S. Glassman today at (617) 367-2900 or using our online form.Transvaginal Mesh Attorney – (617) 367-2900 – Free Consultation