Port Washington, New York (PRWEB) July 10, 2014
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that a couple has brought a lawsuit over allegations that the woman’s hidden, aggressive leiomyosarcoma was spread through her body by a power morcellator used during a routine laparoscopic supracervical hysterectomy procedure. The lawsuit has been filed against Richard Wolf Medical Instruments Corporation over its Wolf Power Morcellator and was brought on behalf of Sarah Salem-Robinson and her husband, Alan A. Robinson, in the Northern District of California on May 13, 2014 (Case5:14-cv-02209-PSG).
Two weeks following the procedure, the woman was advised that one of her fibroids was a uterine leiomyosarcoma, which is a rare and aggressive form of hidden, or so-called “occult” cancer, according to a report dated July 9, 2014 by The Washington Post. To date, she has been diagnosed with four lesions on one lung that, according to her lawsuit, likely are metastatic leiomyosarcoma resulting from the morcellator.
Parker Waichman comments that it is aware of at least one other lawsuit brought over potential injuries suffered following the use of morcellator tools during routine medical procedures. The firm indicates that it also understands that minimally invasive gynecologic procedures in which power morcellators are used present potential, often fatal, patient danger and reduced longevity. Parker Waichman is available to assist women who have suffered injury, or the loved ones of women who have suffered injury, following these procedures. Burkhart v. LiNA Medical US et al., filed on March 14, 2014, Case No. 5:14-cv-1557, in the U.S. District Court for the Eastern District of Pennsylvania, Allentown.
The U.S. Food and Drug Administration (FDA) issued a warning on April 17, 2014 concerning the use of power morcellators during minimally invasive hysterectomies (uterine removal) or myomectomies (uterine fibroid removal), as these surgical tools may spread a hidden cancer, significantly worsening a patient's prognosis and survival. The agency explained that laparoscopic power morcellators break up pieces of tissue during surgical procedures, making the tissue more easily removable through tiny incisions made in the body. The agency communication indicated that power morcellators, when used in women who have an undetected uterine sarcoma (cancer), may spread the cancer to other parts of the body. This adversely impacts a woman’s likelihood of long-term survival. According to the FDA, at least one in 350 women who undergo a hysterectomy or a myomectomy has an unsuspected sarcoma.
“Thousands of women undergo minimally invasive surgeries for hysterectomy or uterine fibroid removal annually. These women are often unaware that use of power morcellators during their procedures may spread a hidden, aggressive tumor,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Our firm continues to investigate cases in which power morcellators may have spread these deadly cancers.”
Following the FDA’s warning over power morcellators potentially spreading hidden cancers, Johnson & Johnson, the largest maker of these devices, announced its discontinuation of its power morcellator lines worldwide, including the “Gynecare Morcellex,” “Morcellex Sigma,” and “Gynecare X-Tract,” according to an April 29, 2014 The Wall Street Journal report. The device maker has not issued a recall of the devices. Several hospitals, including the Cleveland Clinic, have ceased using power morcellators since the FDA recommendation was issued, according to The Washington Post.
The FDA is now looking into taking additional measures, including adding a “black box” warning, the agency’s most serious safety warning, to power morcellator product labeling. An external advisory panel is scheduled to conduct a hearing on the issue this week, which is also expected to focus on the FDA’s 510(k) process, a fast-tracked route in which medical devices are released to market with little or no clinical testing and follow-up if they are found to be significantly similar to a previously approved device.; power morcellators received FDA clearance through the 510(k) route. David R. Challoner, vice president emeritus for health affairs at the University of Florida and lead author of a 2011 Institute of Medicine study criticizes the process as being flawed, saying in an interview that “the morcellation disaster is yet another tragic anecdote of the failure of 510(k),” according to The Washington Post report. “Until we have a means of pre-operatively identifying the few women with leiomyosarcoma instead of fibroids, this technology should be banned,” he added.
Parker Waichman LLP offers free legal consultations to victims of injuries allegedly caused by medical devices, including morcellator devices, and injuries allegedly suffered during fibroid removal. If you or a loved one experienced injuries during a fibroid surgery that might be associated with a morcellator device, please contact the Firm at its Power Morcellator page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).