It should be noted that the AAGL’s stance on uterine morcellation contradicts that of the U.S. Food & Drug Administration (FDA), which has now recommended that such procedures be avoided in most women who require hysterectomy and fibroid removal surgery.
New York, New York (PRWEB) February 17, 2015
The controversy surrounding power morcellators (http://www.morcellatorlawsuit2015.com) shows no signs of abating, as Bernstein Liebhard LLP notes the publication of a new report questioning the financial ties between an executive officer of the American Association of Gynecologic Laparoscopists (AALG) and a morcellator manufacturer. According to a report from The Wall Street Journal, the group had published an analysis in May 2014 which concluded that uterine morcellation “remains safe when performed by experienced, high-volume surgeons.” However, it was not disclosed that this individual, who had received consulting fees from a morcellator manufacturer, had weighed in on the report prior to its publication. Even the AAGL’s president at the time voiced concern that the group had violated its own conflict-of-interest policies, and expressed shock that the “organization would allow their own policies to be ‘flexible.’ ”*
“It should be noted that the AAGL’s stance on uterine morcellation contradicts that of the U.S. Food & Drug Administration (FDA), which has now recommended that such procedures be avoided in most women who require hysterectomy and fibroid removal surgery. Taken in that light, the revelations from The Wall Street Journal are certainly interesting,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.** The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancers following uterine morcellation.
Power Morcellators and Cancer
Power morcellators are used to shred tissue during minimally invasive hysterectomies and fibroid removal surgeries so that it can be removed from the body via a small abdominal incision. In April 2014 – one month before the AAGL issued its report - the FDA publically discouraged doctors from using the devices in gynecological surgeries because of their potential to spread and upstage undiagnosed uterine cancers present in fibroids at the time of surgery. The FDA noted that there is no reliable way to screen for such malignancies prior to surgery, and warned that dissemination of cancer cells via a power morcellator can greatly reduce a woman’s likelihood for long-term survival.***
The FDA went on to issue a second alert in November 2014 which warned against the use of power morcellators in the majority of women who require hysterectomy and fibroid removals because of their cancer risk. The agency also asked morcellator manufacturers to add a new black box warning – the strongest possible safety notice – regarding this life-threatening complication to their labels. Among other things, the FDA noted that the prevalence of unsuspected cancers in hysterectomy and fibroid patients is higher than the clinical community previously understood.
While the AAGL voiced support for a boxed warning, it expressed concerns about the contraindications set forth by the FDA. In statement, the group continued to assert that "appropriately performed power morcellation outweighs the risk of laparotomy in low-risk patients and is an option to be carefully considered by patients and their gynecologists."****
Victims of uterine sarcoma or other gynecological cancers allegedly spread via power morcellation may be entitled to compensation for their injury-related damages. To learn more about filing a morcellator lawsuit, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.
*foxnews.com/health/2015/02/17/how-suspect-hysterectomy-device-got-surgeon-group-blessing/, The Wall Street Journal, (via Fox News) February 17, 2015
**fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, FDA, November 24, 2014
***fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm, FDA, April 17, 2014
****aagl.org/aaglnews/member-update-5-aagl-response-to-fda-guidance-on-use-of-power-morcellation-during-tissue-extraction-for-uterine-fibroids/, AAGL, November 2014
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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Bernstein Liebhard LLP