Several members of Congress simply had enough when it came to hearing about reports of laparoscopic power morcellators actually spreading unsuspected uterine cancers in the process of performing hysterectomies and myomectomies. They told the U.S. General Accounting Office in writing Aug. 7 to get to the bottom of how the relationship between the use of the morcellator and cancer was discovered in 2014, more than 20 years after the minimally invasive surgical devices were on the market. GAO took Congress seriously and announced Sept. 1 that indeed it would investigate.
The letter to the GAO was signed by U.S. Reps. Mike Fitzpatrick, Louise Slaughter, Ralph Abraham, Rosa DeLauro, Bill Pascrell Jr., Lou Barletta, Doug LaMalfa, Anna G. Eshoo, Jan Schakowsky, Chris Smith, Stephen Lynch, and Rick Larsen.
A part of their letter to the GAO reads as follows: “Despite the long history of this device, only recently has the [U.S. Food and Drug Administration] put out guidance that the use of laparoscopic power morcellators increases the risk of spreading unsuspected cancers in women to as high as 1 in 352 cases. As of the date of this letter, the morcellator remains on the market. It is unclear exactly how many women may be dead as a result of an unsuspected cancer having been spread by this device.”
The delegation also brought to GAO’s attention some pretty damning early science and contradictory conclusions about power morcellator safety.
The Congress members wrote: “FDA’s warning came decades after some studies were already pointing to a serious problem. Despite these studies, as late as last year, the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000. How did they get it wrong for so long? In light of these concerns, we respectfully request you investigate the root cause failure that ultimately led to the FDA’s black box warning on the use of laparoscopic power morcellators in Nov. 2014 – over two decades after it was first approved.”
Alarmed by recent evidence of the cancer link, the FDA wrote in a November 2014 statement, “In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.”
These electronic morcellators divide tissue into fragments for removal through small incision sites.
The agency further explained, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.”
One of those telltale morcellator adverse event reports was submitted to the FDA in June 2015, two months after the FDA issued its first safety communication. The maker of the device, Karl Storz GMBH and Company, told the FDA that a company attorney learned of a power morcellator patient whose family had filed suit. “Allegedly, the patient underwent a supra-cervical hysterectomy procedure [in 2012] in which a rotocut morcellator was used, and 5 days later pathology result came back with myxoid leiomyosarcoma. The patient died [in] 2013.”
A woman may want to consult an attorney to determine whether she is entitled to compensation for medical expenses and for other losses if she underwent power morcellation for hysterectomy or myomectomy and since was diagnosed with:
- Uterine cancer
- Uterine sarcoma
- Endometrial stromal sarcoma
- Metastatic leiomyosarcoma
The experienced product liability attorneys at Reich & Binstock, who operate in every state, are representing power morcellation patients and are offering free consultations.