Marketed as a safe and easy solution to pelvic organ prolapse, Elevate is one of the transvaginal mesh implants developed by American Medical Systems (AMS). According to AMS, the Elevate is a “total transvaginal approach to prolapse repair requiring just a single incision,” but while the surgical procedure may be simpler, the surgical mesh introduces risks unique to the device. Recently the FDA issued an alert, warning consumers of the higher risk of complications linked to all transvaginal mesh implants. Both the FDA alert and the AMS website discloses that transvaginal mesh implants such as the AMS Elevate may cause:
- Perforation of urethra, bladder, or bowel
- Mesh erosion through neighboring tissue
- Recurrent incontinence
- Internal bleeding
Symptoms of Pelvic Organ Prolapse
Pelvic organ prolapse (POP) is a relatively common condition that affects approximately 40 percent of women experience within their lifetime. Characterized by pain and discomfort, common symptoms of POP include:
- Pressure in lower abdomen organs
- Pull in the lower back or groin area
- Fullness in lower belly
Women who suffer from recurrent pelvic organ prolapse often opt for surgical treatment, and until recently, an increasing number of women received transvaginal mesh slings as an alternative to traditional surgery. The simplicity of the procedure and the perceived effectiveness of the device led to its popularity.
Transvaginal Mesh Lawsuits
Hundreds of thousands of women have implanted a transvaginal sling over the years, and in 2011, approximately 75,000 women underwent the procedure, unaware of the serious complications linked to the device. Since the FDA alert has been released, thousands of women have filed lawsuits against medical device manufacturers like AMS. Analysts are predicting over 10,000 lawsuits to be filed by patients seeking compensation for the damages resulting from the use of defective transvaginal devices. Already, over 500 plaintiffs have filed lawsuits against AMS, alleging the defective device is responsible for the severe complications patients suffered from the mesh implant.
Protecting Your Rights
A lawsuit against a large medical device manufacturer must be handled properly, as large damages may be at risk. An attorney skilled in product liability is critical to make certain that you receive the maximum compensation you deserve after the injuries the AMS Elevate has caused. Especially when a device extrudes, it is too often necessary to undergo multiple surgeries in an attempt to fully remove the harmful device. Especially in cases where the patient has suffered permanently debilitating injuries, having the right attorney representing the victim can significantly increase the eventual settlement or verdict.
Defective Medical Device Lawyers
Medical companies are not only providing a product to consumers, they are increasing the quality of life for the patients who use their products. Therefore it is critical for medical device manufacturers to recognize their responsibility and take all efforts to ensure their products are safe and effective. Before you begin speaking with AMS or your physician regarding your potential case, consult an experienced defective medical device attorney. A skilled lawyer can review your situation and help you determine the best course of action for your case.