One of the products marketed as a safe and easy fix for pelvic organ prolapse is called Elevate which was developed by American Medical Systems (AMS). Elevate is one of the transvaginal mesh implants. According to the manufacturer AMS, the Elevate is a “total transvaginal approach to prolapse repair requiring just a single incision.”
Some might say that the surgical procedure is in fact simpler, but the surgical mesh introduces risks unique to this device.
The U.S. Federal Food and Drug Administration (FDA) recently issued an alert that warned consumers of a higher risk of complications that are associated with this particular transvaginal mesh implant. In fact, the warning is to consumers for all of those who use transvaginal mesh implants. The FDA alert and AMS website sets out in disclosure form that transvaginal mesh implants, including the AMS Elevate, may cause:
Pelvic Organ Prolapse (POP) is a common condition that affects about 40% of women. The symptoms of pelvic organ prolapse are pain and discomfort generally and also:
Many women who have recurrent pelvic organ prolapse have undergone surgical treatment. Until recent reports of the dangers, the number of women who have been receiving transvaginal mesh slings are on the rise. This was an alternative to the more traditional basic surgery. Because the procedure was easier, less risky and less evasive, it became quite popular.
However, there are hundreds of thousands of women who have been implanted with a transvaginal sling that have resulted in serious medical problems. As of 2011, approximately 75,000 women have had the transvaginal sling procedure. Many lawsuits have been filed against the makers of the device, including AMS.
Many women have suffered irreparable injury because of the failures of the transvaginal devices. As many as 10,000 lawsuits may yet be filed seeking compensation for the damages, medical expenses, lost income and other damages associated with defective transvaginal devices. More than 500 plaintiffs have filed lawsuits against AMS alleging that the defective device caused serious medical complications.
Because of the problems associated with the defective transvaginal products, women have unfortunately undergone multiple surgeries in an attempt to remove the harmful device and to repair the damage.
If you or someone you know has been injured as a result of a failed transvaginal mesh implant or sling, please call us for an immediate free consultation.
Robert Kreisman of Kreisman Law Offices has been handling medical product defect injury cases. Kreisman Law Offices has prevailed in trials and settlements in Chicago, Illinois and surrounding communities and has successfully resolved cases for those injured in transvaginal mesh implant and sling defect devices.
With our 40 years of experience in trying and settling medical product defect cases, Kreisman Law Offices provides the best possible services to our clients and have achieved unsurpassed results. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online. There is no charge for a consultation that will include an evaluation of your case, assessment of your damages such as lost income, lost wages, medical and hospital bills, past and future pain and suffering, loss of normal life and wrongful death.