After First Morcellator Lawsuit Settles, Tracey & Fox Revisits FDA Advisory Panel’s Expert Testimony

July 27, 2015 – – On April 17, 2014, the US Food & Drug Administration released its first power morcellator warning, “discourag[ing]” the medical device’s use in women undergoing fibroid removal procedures over concerns that the morcellator’s spinning blade could spread undetected uterine cancers. Eight months later, the agency would update a strengthened announcement with news that morcellator manufacturers would be required to place prominent “Black Box” warnings on their products.

Between those two warnings, the FDA convened a meeting of the Obstetrics and Gynecological Medical Device Advisory Panel. In July, 2014, fifteen public health officials and medical experts met for two days of what the Wall Street Journal called “often-emotional testimony,” as patients whose cancers had been inadvertently spread by morcellation spoke on the device’s devastating implications.

According to Sean Tracey, Esq., managing partner at Tracey & Fox, the panel’s suggestions “ran the gamut – from stronger warnings and physician education to a complete ban. We now know that a total recall wasn’t implemented, but there were several notable points of agreement.”

For one, Tracey says, the panel agreed that the likelihood of a woman with fibroids harboring an unsuspected uterine cancer was likely higher than previously thought. “The FDA has found that as many as 1 out of every 350 women is at risk,” Tracey continued, “far higher than the 1 out of 10,000 many morcellator lawsuit Plaintiffs say they were quoted by their surgeons. In fact, many of the women testifying before the panel said that they were never warned of the morcellator’s cancer risks at all.”

Following the meeting, Ben Fisher, director of the FDA’s division for reproductive, gastro-renal and urological devices, told WSJ: “there is an increased awareness and an acknowledgement that there’s a real public health issue here.”

The panel’s fifteen members also agreed that no evidence suggested the use of tissue containment bags could reduce the morcellator’s risks. The tissue bag, patented in 1991, was designed by Vance Products Incorporated to “capture” fragments of tissue sent flying by the morcellator’s blade. In their patent application, Vance’s designers noted a “major problem” associated with morcellation: the danger that supposedly benign growths may in fact be harboring “malignant or pathogenic tissue.” With the panel’s rejection of tissue bags, the potential of improving the morcellator’s risk profile “went out the window,” says Tracey.

Perhaps the meeting’s most notable conclusion came when panel members agreed that no factors, including age and race, or diagnostic techniques, even MRIs or a full biopsy, can definitively rule out the possibility that a patient is harboring an undiagnosed uterine cancer. “In essence,” Tracey says, “every woman is at risk, since physicians can’t conclusively tell which fibroids are benign and which are in fact cancer.”

One year after the FDA’s advisory panel, numerous power morcellators remain on the market – and in surgeons’ hands. And with more than 20 morcellator lawsuits already filed in Federal Courts, Tracey & Fox’s power morcellator lawyers continues to provide free consultations to women who believe that a morcellator procedure spread or exacerbated a previously-undiagnosed case of uterine cancer. For a case eligibility evaluation at no cost, call 713.495.2333.

###

Contact Tracey & Fox:

Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002

ReleaseID: 60003071