Articles Posted in medical malpractice

The U.S. Food and Drug Administration this week issued an order to immediately halt the sale and distribution of pelvic mesh product for treatment of pelvic organ prolapse.vaginalmesh-300x225

Boston Scientific and Coloplast are the only two companies in the U.S. still selling mesh to treat pelvic prolapse. The FDA order immediately prohibits the sale of Boston Scientific’s Uphold Lite and Xenform mesh products, as well as Coloplast’s Restorelle DirectFix.

Our medical device injury attorneys have been watching the issue closely as tens of thousands of women have been seriously injured by mesh implantation. Still, Boston Scientific and Coloplast have continued to market and sell the product 7 years after the FDA issued an emergency order mandating device makers prove their products are safer and more effective than traditional surgical repair.

In Minnesota, a local news article touted a new robotic surgery for total hip replacements at a nearby hospital. The article noted surgeons were relying less on the imperfect human eye and fallible human hand and instead leaning on the precision of robots. monitor

The latest investment for the local surgical center costs millions of dollars. It’s an arm-assisted system, and promises to “take the guesswork” out of placement of hip replacement implants, allowing patients to receive fits that are customized. It’s one of two surgical centers in that state to use the robotic arm system, which was manufactured by Stryker – the same company at the center of hip replacement and knee replacement litigation for defective products.

Approximately 400 to 550 hip replacements are done at this surgical center alone each year. The hope is to reduce the number of additional surgeries sometimes needed to correct improper placement of hip replacements, which is largely attributed to “eyeballing techniques” used by surgeons to get the parts in the right place.

A 53-year-old chemist and college instructor was diagnosed with fibroids earlier this year. Fibroids are very common among women and, while they can cause bleeding and pressure, fibroids are not generally considered dangerous and are benign growths. However, the patient was scheduled for a minimally-invasive hysterectomy in order to remove her uterus through a small incision as a method of treating the symptomatic fibroids. surgery-117629-m.jpg

Her procedure was to involve the use of a morcellator. At the time, morcellators were widely used as a method of treating fibroids. The morcellators were used to slice up fibroids or tissue growths so the tissue could be removed in pieces through a smaller incision. However, the patient read about a debate among doctors in which some physicians were expressing growing concern about the use of this medical device. She raised her concerns with her doctor, who thought that the risk of complications was rare but who respected her position and performed a procedure removing her uterus vaginally without the use of the power morcellator.
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Uterine fibroids are very common during a woman’s childbearing years, with as many as three out of four women developing fibroids at some point in their lives. Fibroids are often asymptomatic and are benign and almost never develop into cancer. They form from the smooth muscular tissue of the uterus, and they range from tiny seedlings to bulky masses that can cause the uterus to become enlarged. Fibroids are often removed surgically and, for many women, a power morcellator is used to grind down tissue in order to make it possible to remove the fibroids through a very small incision. woman-in-hospital-1051476-m.jpg

Unfortunately, some women who are diagnosed with fibroids actually have an undiagnosed uterine sarcoma within the allegedly-benign growths. When a morcellator is used, it can significantly worsen the patient’s chance of survival if it turns out that she has an undiagnosed uterine sarcoma. Because of these risks, the Food and Drug Administration issued an advisory recently warning against the use of this medical device. Unfortunately, many women already had a procedure using a morcellator and their cancer risk was made much worse as a result. Those who are affected should contact a medical malpractice lawyer for help taking legal action.
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