Advances in medical technology are amazing and can provide great benefits to patients. Unfortunately, sometimes the products created to help people can end up causing more harm than good. In this type of situation, victims can seek compensation not only from the doctors or hospitals involved in the procedure, but also the company that created and marketed the product.
One medical product that is under intense scrutiny right now is a mesh that is implanted in various parts of the abdominal area to treat bulging organs, called pelvic organ prolapse (POP), or incontinence due to weakened tissues around certain organs. In 2011, the FDA updated its report on the use of vaginal mesh implants. The update states that serious complications are more frequent than initially thought and that it is unclear whether surgery that includes the mesh implant is any more effective than the traditional method. Between 2008 and 2010, the FDA received 2,874 reports regarding medical issues associated with the vaginal mesh implants including “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding,…dyspareunia,…organ perforation, urinary problems… recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.” In January, 2012, the FDA told numerous manufacturers of this product to perform a three-year study to confirm it is safe and effective.
Hundreds of victims have filed medical malpractice lawsuits claiming these implants are causing additional medical issues. One case has already gone to trial and been decided by a jury. The victim had claimed that her vaginal mesh implant that had been manufactured by C.R. Bard Inc. caused chronic pain and incontinence and that she had endured nine surgeries to try to fix the problems caused by the implant. The lawsuit, which was filed against both the manufacturer and the doctor who performed the surgery, alleged that the company had not thoroughly tested the product before selling it, despite the fact that the FDA had approved it. The jury determined that the manufacturer was 60 percent responsible and the doctor was 40 percent responsible. The victim and her husband were awarded $5.5 million for pain and suffering, medical expenses, and loss of consortium.
As for the other cases, the majority of them have been consolidated and will be heard by a judge in West Virginia. Companies involved include Bard, Boston Scientific Group, American Medical Systems and Endo Pharmaceutical Holdings, Inc. Also included is Johnson & Johnson, which recently sent out a voluntary product recall on four of its vaginal mesh devices.
What should Kentucky residents do if they think they have been affected by one of these mesh implants? They should contact a Kentucky medical malpractice attorney. Like other types of cases, medical malpractice cases have a filing deadline, called the statute of limitations, so they should call an attorney as soon as possible. The attorneys at Miller & Falkner handle medical malpractice cases as well as many other types of personal injury cases for residents throughout Kentucky and Indiana.
Bard, doctor ordered to pay $5.5 million over implant; Bloomberg Businessweek; Jef Feeley; July 25, 2012