Millions of Americans have medical devices implanted in their bodies, from pacemakers to artificial hips and surgical mesh. Unfortunately, what most people don’t know is that many of these devices are allowed on the market without advanced safety approval by the U.S. Food and Drug Administration, which regulates medical devices.
Transvaginal Mesh Led to Serious Nerve Damage
In 2007, Janet Holt of Floresville, Texas, went to her gynecologist with swelling in the pelvic area. Her doctor informed her that she had a prolapsed uterus and bladder, where the organs had dropped out of position. Her doctor used transvaginal mesh to build a “bird’s nest” to hold the organs up. Unfortunately, after the surgery, Janet was in constant pain and unable to return to working on her cattle ranch. After 14 surgeries to adjust and remove the transvaginal mesh, which had shrunk and shifted in her body, Janet had permanent nerve damage in one leg. She sued the manufacturer of the transvaginal mesh.
Vagus Nerve Stimulator Stops Man’s Heart
Dennis Fegan, a retired Corpus Christi oil worker, suffered what he thought were multiple seizures beginning at 2 am one night in 2006. When his parents found him late the next morning, he fell unconscious to the floor right in front of them, only to regain consciousness and then pass out again, time after time. When the ambulance got him to the hospital, they discovered that his heart was stopping every three minutes. Fegan had a vagus nerve stimulator (VNS) implanted to stop seizures years before. Instead, the VNS was stopping his heart. The incident propelled Fegan into a decade-long battle with Cyberonics, the manufacturer of the VNS, and federal regulators. The VNS is still on the market.
Artificial Hip Joints Failed at High Rates and Caused Metal Poisoning
Stephen Tower, M.D., an orthopedic surgeon from Anchorage, Alaska, was also the victim of a dangerous medical device. In 2006, he opted to replace his arthritic hip with an artificial hip by DePuy. The ASR XL hip was notable because the ball at the top of the femur and the socket liner inside the pelvis were made from a chrome-cobalt metal instead of traditional plastic. While the artificial hop worked well for Dr. Tower at first, after a year he had constant pain, high levels of chromium and cobalt in his blood, as well as hearing loss and vision problems. After he had the DePuy metal hip replaced with a new ceramic and plastic joint in 2009, his symptoms markedly improved. In August of 2010, after research indicated that the metal hip failed at a significantly higher rate than other artificial hips, DePuy recalled all 93,000 ASR XL hips worldwide.
If you believe you’ve been injured by a medical device, let the skilled litigators and medical malpractice attorneys at Lowenthal & Abrams help. Contact us now for a free consultation at 888-979-7298.