A Netflix documentary titled The Bleeding Edge focuses on how medical device innovation can lead to devastating consequences for patients. “It’s not just the devices we actually show in our film, it’s actually devices across the board. The system is flawed and it puts patients unnecessarily at risk and that’s why we made this film,” said … Read More
According to a Johns Hopkins study, in the last 25 years diagnostic errors – not surgical mistakes or medication overdoses – accounted for the largest number of medical malpractice claims in the U.S. A misdiagnosis can be scary and costly with patients receiving health care, surgery, and/or medications that are not medically necessary. How does … Read More
A patient may bring a medical malpractice lawsuit against a doctor, healthcare provider or a hospital if they can prove the parties failed to perform their duties competently and with a reasonable standard of care. Medical mistakes can cause new or aggravated injuries that result in permanent damage, and sometimes in death. According to an … Read More
In, April 2014, The FDA issued a safety communication discouraging doctors from using power morcellator devices to remove uterine fibroids because of risk of spreading undiagnosed cancer throughout the abdominal cavity. A recent from The Cancer Letter, an online source on development of cancer therapies, cancer research funding and health care finance, legislation and policy published … Read More
The American Urological Association (AUA) held a special press conference at their May Annual Scientific Meeting in Orlando, FL to announce the results of four studies conducted by medical research centers throughout the U.S. The studies centered around patient knowledge and perception of transvaginal mesh products prior to surgery as well as after mesh removal. … Read More
Another transvaginal mesh manufacturer has agreed to settle transvaginal mesh injury lawsuits. According to a Reuters article titled: “Endo agrees to $830 million settlement of vaginal-mesh cases,” Endo International Plc said Wednesday it has agreed to pay $830 million for lawsuits brought by women claiming they were injured by transvaginal mesh devices. The company said … Read More
It appears after six years and thousands of lawsuits for transvaginal mesh injuries, the U.S. Food and Drug Administration (FDA) is proposing to reclassify the surgical mesh for pelvic organ prolapse (POP) repair to a “high-risk device.” Med Page Today, a news service for physicians, published an article titled: “FDA Wants High-Risk Label for Transvaginal … Read More
It’s a common assumption that all new medical devices go through the same rigorous safety tests before being introduced into the marketplace. However, the agency in charge of overseeing the release of medical devices, the U.S. Food and Drug Administration or FDA, has determined that some devices require pre-market approval and that others do not. … Read More
Those seeking hip or knee replacement surgery are almost always focused on one thing: increased mobility or pain alleviation. A recent Consumer Reports’ Safe Patient Project shared on WMC-TV article titled: “Consumer Reports: Hip and knee replacement caution” reminds people considering hip or knee replacements that there can be serious complications associated with the surgery that they … Read More
People who elect to have hip or knee replacement surgery expect a reasonable amount of pain relief and increased range of motion as a result of these invasive procedures. Given the advances in medical device technology, there is no reason to think otherwise. However, some defective medical devices are not living up to their promise … Read More
