Medical devices have helped improve the quality of our lives, but it is up to individual patients to research the risks and benefits of these devices before undergoing any procedure. In particular, several medical devices in recent years have had a negative impact on women’s health. Here is a list of four medical devices that have been associated with serious and sometimes fatal complications.
- Laparoscopic Power Morcellators – These devices hit the market in 1991 offering less invasive removal of uteruses and fibroid growths than traditional open surgeries for hysterectomies and myomectomies. Power morcellators shred the uteruses or fibroid tumors inside the body and remove them through small incisions in the abdomen. Every year, about 50,000 procedures using power morcellators were performed until a handful of patients and their family members began sounding an alarm. Power morcellators can spread previously undiagnosed uterine cancer and worsen one’s odds of survival. In November 2014, the Food and Drug Administration (FDA), following a safety review, alerted doctors that the devices should not be used to perform hysterectomies or myomectomies in most women because there is no reliable way to diagnose uterine sarcoma before fibroids or the uterus is removed. If cancer found to be present, power morcellation can spread the disease, making it more difficult to treat.
- Transvaginal Mesh – Many women suffer from pelvic organ prolapse or stress urinary incontinence, conditions in which the pelvic organs fall within the pelvic cavity causing discomfort, painful sexual intercourse, and urinary incontinence. One common procedure to treat these conditions was with a device called transvaginal mesh or bladder sling, which is designed to hold up organs that have fallen. However, complaints began rolling into the FDA at a surprising rate. The transvaginal mesh could erode inside the body, cause a buildup of scar tissue and entrapping nerves, resulting in chronic pain, infections, hemorrhaging, disability and urinary and fecal incontinence. Hundreds of lawsuits have been filed against the makers of transvaginal mesh, with several resulting in tens of millions of dollars in compensation to victims.
- Mirena IUD – Bayer Healthcare offered women contraception without the inconvenience of taking a daily pill when it introduced the Mirena IUD. The device is inserted into the cervix and releases a hormone that works to prevent pregnancy for up to five years. However the company failed to warn women that the device could migrate from its intended location, wander throughout the abdominal cavity and puncture organs causing pain and hemorrhaging. These runaway IUDs almost always require surgery to be removed and in some cases require the removal of the uterus, rendering women sterile.
- Metal-on-Metal Hip Implants – Diminishing estrogen levels as women ages put them at greater risk of hip fracture and other problems that reduce quality of life. Hip replacement systems can bring mobility back. Traditional hip implants are made with ceramic or plastic parts; however, newer versions have been made with all-metal parts. The assumption was that these metal-on-metal devices would be more durable, but the devices began failing at a higher than expected rate. The problem was caused by the corroding of metal inside the body, inflaming surrounding tissue and sending bits of metal ions into the blood stream, causing a type of blood poisoning known as metallosis. While all-metal hip implants are being used less these days, many people who received the devices required revision surgery to remove and replace their failing devices. Others have had to undergo regular monitoring to check for signs of the implant deteriorating.
Lawyers at Beasley Allen are handling claims related to all the medical devices mentioned above. If you or a loved one suffered serious injury, or if a loved one died after receiving one of these devices, an attorney is available to speak with you. You may fill out a consultation form on this website for a free, no-obligation evaluation of your claim.
Source: Righting Injustice