U.S. Senators Nudge FDA for Power Morcellator Withdrawal
Two U.S. senators are urging power morcellator manufacturers to take their products off the market as quickly as possible, given their possible association with the spread of uterine sarcoma and other cancers.
A spokesperson for Chuck Schumer and Kirsten Gillibrand said on August 18th, 2014 that the officials sent a letter to the U.S. Food and Drug Administration (FDA) to address the possible issues surrounding uterine morcellation, a type of procedure performed in fibroid removal and laparoscopic hysterectomy procedures.
In a draft of the letter reviewed by the Wall Street Journal, Schumer and Gillibrand ask the federal agency to “request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments, and patient and clinician education can be performed.”
Senators ask FDA to “Seriously Consider” Alleged Power Morcellator Victims
An FDA spokeswoman said the letter was received, and that the agency will respond to the New York Democrats directly. In April 2014, the agency warned the public about possible dangers associated with uterine morcellation, estimating that 1 in every 350 women undergoing fibroid removals may have undetected uterine sarcoma that may not be discovered until after the fibroids are removed and biopsied. Johnson & Johnson suspended sales of power morcellators marketed by its subsidiary, Ethicon Inc. after the alert was issued, a decision the company later followed up with a “worldwide market withdrawal” announced on July 30th.
In Schumer and Gillibrand’s letter, the FDA was urged to “seriously consider and not discount the testimony presented during the FDA’s July hearings by our constituents who devastatingly lost family members to cancer after a power morcellation procedure.”
Morcellator manufacturers including Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical have not commented on the senators’ request, according to the Journal, which also states that Olympus Corp (ADR) (OCPNY) hasn’t either. Over the course of 2013, Olympus reportedly earned $2.7 billion from a unit that includes its morcellators, the last quarter of which resulted in $0.66 billion sales.
As uterine morcellation concerns continue to make waves in the U.S., court records indicate that numerous claims have been filed by women exposed to the surgical tool. These power morcellator lawsuits are currently pending in courts throughout the U.S.
Pursue a Power Morcellator Lawsuit
Contact a power morcellator lawyer to find out more about risks associated with the device, and to find out if you are eligible to file a claim. Call us now at (877) 779-1414.