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power morcellators 16 articles

Ultrasonic aspiration discouraged for uterine fibroid removal

Ultrasonic surgical aspirators should not be used to remove uterine fibroids because there is a risk that the devices could cause the unintended spread of uterine cancer, worsening the patient’s odds for survival, the Food and Drug Administration (FDA) said. The agency issued a nonbinding guidance recommending that companies that make a devices label them with a contraindication for uterine fibroid removal due to this risk. Ultrasonic aspirators are devices fitted with an oscillating tip that break up and emulsify both hard and soft tissues into fragments with ultrasound energy and then remove them from the body through a small ... Read More

Representative introduces bills to protect women from dangerous medical devices

A bill known as Ariel Grace’s Law, designed to help women who claim they were injured by the permanent birth control device Essure fight back against the manufacturer of the device, was introduced on the House floor this week. This happened just as a second bill, called the Medical Device Guardians Act, was filed, giving physicians a more effective way of reporting problems with medical devices to the Food and Drug Administration (FDA). Both bills were introduced by Rep. Mike Fitzpatrick, who is helping raise awareness of the need for closer scrutiny of medical devices. He has taken up the fight for ... Read More

Rep. Fitzpatrick to announce medical device reform bills

This week, Rep. Mike Fitzpatrick (R-PA) along with Rep. Louise Slaughter (D-NY) will announce a package of bills aimed at strengthening the Food and Drug Administration’s (FDA) medical device review process and increasing the accountability for dangerous products. They will be joined by women and families affected by medical devices including the permanent birth control method Essure and the laparoscopic hysterectomy device power morcellator. Speakers will share the emotional effects they say they experienced as a result of these allegedly failed medical devices, and their fight for justice. Fitzpatrick has been the leading voice in Congress calling for medical device approval ... Read More

Will other power morcellator makers move to settle lawsuits?

Johnson & Johnson’s Ethicon, maker of about three quarters of the power morcellators on the market, has made efforts to settle almost all of the lawsuits alleging its device caused the spread of undetected uterine cancer. The company hasn’t said why it’s taken such swift measures to resolve the lawsuits, but manufacturers of other power morcellators are sure to take note. Power morcellators are surgical tools used for laparoscopic hysterectomies and myomectomies (uterine fibroid removals). The tools are fitted with a long, tube-like blade that shreds entire uteruses or uterine growths within the body and removes them through a small ... Read More

Johnson and Johnson, plaintiffs close to settling power morcellator lawsuits

Johnson & Johnson and its subsidiary Ethicon are making a move to settle dozens of lawsuits involving its hysterectomy tool that’s been blamed for spreading undetected uterine cancer. The lawsuits involve power morcellators, which have tube-like blades that shred uterine fibroids or entire uteruses within the body and remove the tissue through a small incision in the abdomen. Johnson & Johnson was a top seller of power morcellators, but stopped selling the devices in 2014 after the Food and Drug Administration (FDA) warned that about 1 in 350 women had undiagnosed uterine cancer that could be spread by power morcellation. One ... Read More

Rep. Fitzpatrick calls for probe into deaths linked to power morcellators

Rep. Mike Fitzpatrick is urging the U.S. Food and Drug Administration (FDA) to launch a criminal probe into the deaths of women who have undergone gynecological surgeries using power morcellator devices. Power morcellators are surgical tools fitted with a long, tube-like blade that shreds uterine fibroids or entire uteruses inside the uterine cavity and removes them through a small incision in the abdomen. In April, the FDA issued a warning that power morcellation for hysterectomies and myomectomies can spread undetected uterine cancer, worsening the odds of survival. In November, the FDA ordered black box warnings be placed on the devices ... Read More

Cancer spread with power morcellators among 2015 top medical news

A medical device used to perform laparoscopic hysterectomies and myomectomies (uterine fibroid removals) was among Medscape’s top news-making events this year in the Ezine’s annual “The Year in Medicine.” Medscape’s recap of “News That Made a Difference” identifies which medical news and events affected health care professionals the most during the year. The topics are identified by readers, the majority of whom represent the medical community. The list includes a gynecological tool called a power morcellator. In September, federal investigators launched a probe into the risk of cancer spread with power morcellators, surgical tools used to perform laparoscopic hysterectomies and ... Read More

Four medical devices that can maim women

Medical devices are designed to help improve quality of life, but these four products have been linked to serious injuries and even death in women, resulting in personal injury and wrongful death lawsuits. Transvaginal mesh – This surgical mesh is implanted through the vagina to hold up organs that have fallen due to age, childbirth or obesity, resulting in conditions known as stress urinary incontinence and pelvic organ prolapse. Transvaginal mesh, also known as bladder slings, are designed to curtail symptoms such as pain, discomfort and incontinence. According to the Food and Drug Administration (FDA), the mesh has been associated with ... Read More

Top 3 dangerous devices made by Johnson & Johnson

Johnson & Johnson is a multinational medical devices, pharmaceutical and consumer health care manufacturer with more than 250 subsidiary companies that sell products in more than 175 countries. The company generates tens of billions of dollars in sales each year. Despite its success, Johnson & Johnson is riddled with lawsuits involving safety concerns with many of its products. Here is a list of some of the company’s medical devices and surgical tools that have raised safety concerns in recent years. DePuy Hip Replacement Systems Johnson & Johnson subsidiary DePuy Orthopaedics’ metal-on-metal hip implant was intended to be more durable than traditional ... Read More

Judicial panel discusses consolidation of power morcellator lawsuits

The U.S. Judicial Panel on Multidistrict Litigation is meeting this week to determine whether it would be beneficial to consolidate lawsuits involving similar allegations against the manufactures of power morcellators, medical devices used to perform some gynecological procedures including hysterectomies and uterine fibroid removal. The lawsuits allege that the devices can spread undiagnosed uterine cancer, worsening a woman’s odds of survival. The consolidation of lawsuits under one single judge, known as a multidistrict litigation, or MDL, was requested by plaintiffs who have already filed lawsuits against power morcellator manufacturers. MDLs are generally sought to streamline early trial proceedings when several ... Read More