Congressional Letter to GAO
The GAO’s action came after a dozen members of Congress wrote a letter requesting that the agency investigate. The legislators wrote the GAO a letter dated August 2, 2015:
“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator. (This) device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”
The representatives’ letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).
FDA Limits Morcellator Use
FDA severely limited power morcellator use in November 2014, a year after doctors and patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign against the device.
Morcellator National Security Threat
Dr. Amy Reed became a power morcellator victim after one was used on her for a hysterectomy. Her husband, Dr. Hooman Noorchashm then became something of a whistleblower. He announced that morcellators were a national security threat, given that 1 in 350 women have undetected uterine cancer prior to hysterectomy or fibroid removal. When that woman with undetected cancer undergoes surgery with a morcellator, her cancer can be morcellated – sliced and diced – into millions of pieces which are then spread everywhere throughout the uterus. The result can be aggressive uterine cancer or other type of cancer that can be fatal.
Doctors push Back
Some doctors, meanwhile, have pushed back against the proposed morcellator ban. The morcellator offers the convenience of a less invasive procedure. Fewer sutures are needed in using the morcellator, compared with the old methods used for hysterectomy and myomectomy or fibroid removal. The problem remains, however, that the ovarian cancer testing which doctors have used prior to surgery in order to diagnose possible cancer has not proven reliable.
Against this backdrop, morcellator lawsuits have been filed across the country for women with undetected cancer who then underwent surgery with a power morcellator, only to find that the machine spread and worsened their undetected cancer.
Power Morcellator Investigation by Government
Meanwhile, the power morcellator investigation by the U.S. government continues. Stay tuned for further developments. . .