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Category Archives: Unsafe Medical Devices

FDA WARNS AGAINST VAGINAL REJUVENATION PROCEDURES

Posted By Anapol Weiss on this August 8, 2018 at 9:37 pm
On July 30, 2018, the FDA issued a warning against the use of energy-based (most commonly radiofrequency or laser) devices utilized to perform vaginal rejuvenation procedures. These devices have been approved by the FDA for gynecological purposes such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue and genital warts. However, several manufacturers of these devices have been...
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Surgical Instruments Left Inside Patients

Posted By Anapol Weiss on this May 2, 2016 at 11:30 am
The scenario seems like one from a horror movie: a patient does not feel right after surgery; months or years later, a medical emergency leads doctors to find a foreign item – now infected and surrounded by scar tissue – had been left inside the patient’s body. The situation becomes life-threatening. Tragically, these surgical “never events” have happened to at...
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Preventing Surgical Instruments from Being Forgotten Inside Patients

Posted By Anapol Weiss on this March 4, 2016 at 3:30 pm
A surgical object mistakenly left inside a patient is a medical emergency that can lead to death or permanent health problems. Shockingly, surgical instruments are left inside patients thousands of times every year in the United States. Surgical sponges account for nearly 70 percent of items left inside patients. Other items commonly found on post-op X-rays include: retractors, sharp objects...
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FDA: No Reported Adverse Events Involving Morcellation Cancer Upstaging for 8 Years

Posted By Anapol Weiss on this February 15, 2016 at 11:00 am
Federal law requires the reporting of adverse events, but for eight years the U.S. Food and Drug Administration (FDA) did not receive reports of cases involving power morcellation and the spread of cancer. Between December 2013 and November 2014, however, the FDA received about two dozen reports discussing cancer and upstaging or dissemination – but all of them pertained to...
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Responses to Use of Power Morcellators by the FDA, FBI, GOA and Market

Posted By Anapol Weiss on this February 3, 2016 at 11:30 am
The first reference to power morcellators spurring the ongoing controversy was in December 2013 when the Wall Street Journal profiled Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Reed underwent a routine morcellation laparoscopic hysterectomy at Brigham & Women’s Hospital to remove uterine fibroids and discovered – after the surgery – that the mass...
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Medical Journal Highlights Current Power Morcellator Debate

Posted By Anapol Weiss on this January 27, 2016 at 11:30 am
This January issue of Obstetrics & Gynecology features two articles diametrically opposed in their messages as to the true risk of power morcellation. In this month's issue, a group of 48 top gynecological surgeons, headed by William Parker of UCLA, and a few women’s health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (NUFF.org), published a letter directed...
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What Is a Power Morcellator?

Posted By Anapol Weiss on this January 20, 2016 at 3:35 pm
  Power morcellators are made by multiple manufacturers, and provide a less-invasive option in gynecological surgeries. They are shaped much like a drill, and can be inserted into a woman’s lower abdomen through a tiny incision. Once inside, during hysterectomies or myomectomies, they work by rapidly spinning blades which shred, grab and/or and chop up organs and tissue for removal...
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Larry Cohan Appointed To Ethicon Power Morcellator PSC

Posted By Anapol Weiss on this November 24, 2015 at 3:02 pm
A hearing was held in the Ethicon Power Morcellator multidistrict litigation (MDL) in front of U.S. District Judge Kathryn H. Vratil and U.S. Magistrate Judge James P. O’Hara on November 18, 2015. Attorneys for plaintiffs and defendants were present. The Court entered an order memorializing its rulings and setting forth additional procedures. The Court appointed Anapol Weiss partner Larry Cohan...
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Power Morcellator Surgery Victims Have Their First Day in Court as Consolidated Cases

Posted By Anapol Weiss on this November 18, 2015 at 2:37 pm
At 1:00 p.m. CST today, women and their families who suffered injuries as a result of a power morcellator will have their first day in federal court as a consolidated litigation in front of the Honorable Kathryn H. Vratil in the United States District Court for the District of Kansas. On October 15, 2015, the United States Judicial Panel on...
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Power Morcellators – the Risk of Spreading Uterine Cancer and Fibroids Exposed

Posted By Anapol Weiss on this November 13, 2015 at 4:07 pm
One in 352 Women Women undergoing a routine laparoscopic hysterectomy or myomectomy (fibroid removal surgery) with a power morcellator are at risk of spreading cancerous and infected uterine tissue throughout their bodies, reported the U.S. Food and Drug Administration (FDA) in April 2014. According to the analysis of scientific literature, the prevalence of unsuspected uterine sarcoma – a type of...
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