publication date: Aug. 27, 2014
A German company that makes devices now under FDA scrutiny for their potential to spread sarcoma threatened legal action against the U.S. surgeon whose wife’s cancer cells were disseminated during routine surgery to remove fibroids.
Setting decorum aside, Hooman Noorchashm has been haranguing FDA, Congress, and the gynecology and oncology profession into partial abandonment of the procedure. Though he hasn’t sued anyone, several law firms are looking for women harmed by the procedure who would be willing to take part in litigation.
As an apparent result of this campaign by Noorchashm and his wife Amy Reed, top institutions—including Brigham and Women’s Hospital, where Reed underwent the procedure—are moving away from routine use of morcellation, and some insurers are refusing to pay for the procedure.
One of the largest manufacturers of these devices—Ethicon, a unit of Johnson & Johnson—recently voluntarily withdrew the devices, which cost between $1,500 and $3,000 each.
Power morcellation is performed on an estimated 100,000 women in the U.S. a year with a minimally invasive device that pulverizes a patient’s fibroids into fragments for easy removal through a small incision. The problems occur when power morcellators disseminate cells from undetected cancers.
The Karl Storz Group, the company that Noorchashm says made the device that was used in Reed’s surgery, is taking a different approach.
|The Letter from the Karl Storz Group to Noorchashm Threatening Legal Action|
Dear Dr. Noorchashm,
This refers to several emails which you addressed—amongst others—to Dr. h.c. mult. Sybill Storz, the CEO of the KARL STORZ Group.
In your emails, you requested Dr. Storz to “recall your Rotocut morcellator device from the market”, arguing that it caused harm to patients. You also urged Dr. Storz that she “must do right by all those who have been harmed’’ (21 May 2014) and you sent her (and other recipients) a collage of “30 women, some dead’; calling them “Your victims. Victims of your standard of care and using your robotic a power morcellator devices”. Again, in this email (24 June 2014) you imply that the power morcellator was the cause of some women’s deaths.
|The Cancer Letter’s Past Coverage|
Of the Power Morcellation Controversy