Tracey & Fox first reported on May 28th, 2015 that the Federal Bureau of Investigation was looking into allegations against Johnson & Johnson regarding one of the surgical tools it manufactured, the power morcellator. The FBI is concerned that Johnson & Johnson were aware of the heightened risks of spreading uterine cancer when the tool was used in laparoscopic surgeries, prior to 2014. That investigation continues today.
The power morcellator is a tool often used by doctors in hysterectomies or myomectomies. A hysterectomy is performed to remove the uterus, and a myomectomy is performed to remove fibroids from the uterus. The morcellator became popular very quickly after its initial release, due to its ability to provide doctors with a minimally invasive way to remove unwanted tissue from the uterus. During laparoscopic procedures the morcellator is inserted in the abdominal cavity where it cuts the unwanted tissue into smaller pieces that then can be removed. However, the public was unaware that there were risk factors associated with the use of the morcellator.
The FDA initially released a Safety Communication regarding the use of morcellators in April 2014, which it later updated on November 24th, 2014. That communication states that “Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.” This is dangerous to women in whom the cancer remains undetected, because as the morcellator cuts the unwanted tissue in the uterus, it also can move cells to previously untouched areas of the abdomen - a similar effect to sawdust coating the area around where wood is sawed. If a women has undiagnosed sarcoma, it is possible that the use of a morcellator can spread that cancer to other areas of the body.
Johnson & Johnson withdrew all sales of the morcellator and began to advise doctors against the use of the tool in April 2014. However the FBI is investigating disturbing allegations that Johnson & Johnson had been aware of the increased risks as early as 2006, prior to the FDA report.
Despite the FDA placing a “black box warning” on the power morcellator, manufacturers other than Johnson & Johnson continue to sell their products in the United States. There have been an increasing number of lawsuits against the manufacturers of morcellators by women who are alleging the tool caused their undiagnosed uterine cancer to be spread to other parts of the body. Women who are scheduled to undergo either a hysterectomy or myomectomy should consult with their doctor regarding how the procedure will be performed.
For questions regarding this press release, contact Tracey & Fox at (713) 322-5412.
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Contact Tracey & Fox:
Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901 Houston, TX 77002
