Cancer Risk: FDA call for strict warning or ban
The power morcellator is a product of Ethicon, a medical device division of the pharmaceutical company Johnson & Johnson. The morcellator instrument cuts and minces fibroid tumors and other tissue in the uterus into small pieces that can be removed through the smaller incisions used in minimally invasive surgery.
May 28, 2015: The FBI is investigating J&J and its subsidiary Ethicon that makes morcellators to see what and when they knew about the serious cancer risk. The Wall Street Journal story The FBI is Investigating Hysterectomy Device Found to Spread Uterine Cancer is a serious review of a medical device industry practice – allegations of withholding safety information – that may have have caused women to develop life-threatening uterine cancer.
WHAT ARE THE FDA WARNINGS?
Although the device has been in use more than twenty years, there has been mounting concern in the last year based on increasing reports of women developing cancer after its use, which has prompted FDA advisers to call for “Black Box” warnings on, or to a ban of, the device.
A recent study from Columbia University estimates that one out of every 368 women has undetected cancer at the time of their hysterectomy. The FDA says the risk is even greater, that one in 350 women may have unsuspected uterine sarcoma.
According to an article about the panel’s recommendation in the Journal of the American Medical Association, there is no certain way for doctors to know if a fibroid tumor is malignant before a hysterectomy. If the tumor is cancerous, then use of the morcellator puts women at risk.
The risk is considered significant enough that hospitals are no longer using the device and insurers are no longer covering procedures that use the morcellator.
WHAT ARE THE SYMPTOMS THAT MAY INDICATE YOU ARE AT RISK?
If a woman has a surgical procedure including the use of a power morcellator, cancerous cells could be spread throughout her abdomen, putting her at risk of developing an aggressive form of cancer, uterine sarcoma. Women who have developed cancer following hysterectomies are encouraged to contact the defective medical device attorneys at Sheller, P.C., a national law firm. If you are uncertain if the device was used in the surgery, our firm will work with your doctor to determine if the device was used in the procedure.
VIDEO – A Life Shattered by Surgery
Use of the morcellator has, in a number of patients, turned undetected cancer into advanced stage 4 cancer.
J&J alerted to risks in 2006 according to doctor
In spring 2014 amid reports of the potential risk, the manufacturer suspended distribution worldwide and at the end of July recalled all the devices. But concerns were voiced in the medical community as early as 2006.
Western Pennsylvania Dr. Robert Lamparter contacted the manufacturer to report patients developing cancer after use of the device. He was told, according to an article in the Pittsburgh Business Times, that a warning would be added to the device. It was never added, and the doctor’s concerns were later discounted by the manufacturer according to the article.
“It’s criminal what they’re doing to people”: Doctor mounts national campaign
“It spreads everywhere,” says 41-year-old Dr. Amy Reed in a Pittsburgh Business Times article, an anesthesiologist and surgical intensivist at Brigham and Women’s Hospital in Boston, who had a biopsy, ultrasound and MRI to check for cancer before a hysterectomy with a morcellator last October.
“They spilled it inside. You can’t keep track of all the pieces. It’s criminal what they’re doing to people.” Reed, the mother of six young children, has advanced cancer she says resulted from power morcellation. She and husband Dr. Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, have mounted a national campaign to stop use of the device.
Six days after her morcellation in 2012, Bonnie Davis got a call from her doctor. “He said it was cancer. He said it was rare,” Davis says. “I was devastated.”
Davis and Jim O’Neill didn’t make the connection between the morcellation and late-stage cancer until two years later when a tumor appeared on her thyroid. It was the same rare kind identified after her hysterectomy. The tumor was removed and so was another one found in recent months on her bladder.
O’Neill later confronted the surgeon, angry about not being fully informed of the surgery’s risks. “‘I don’t have time to sit down and tell you every single risk,’” he remembers the doctor saying.
“It gets me so mad. You put your trust in doctors, what they tell you. I didn’t go to medical school. I have to believe this guy.”
LINKS & RESOURCES:
U.S. insurer to stop coverage of gynecological procedure, Reuters, August 2, 2014
FDA Advisers Call for Black-Box Warning or All-Out Ban on Morcellators in Fibroid Removal, The Journal of the American Medical Association, July 14, 2014
A Life Shattered by Surgery (Video), Pittsburg Business Times, June 20, 2014
J&J alerted in 2006 to device’s surgical risks, doctor says, Pittsburgh Business Times, May 30, 2014
IF YOU BELIEVE YOU OR ANYONE YOU KNOW HAS SUFFERED THE CANCER-SPREADING EFFECT OF MORCELLATOR SURGERY, CONTACT OUR OFFICE TO PROTECT YOUR HEALTH NOW AND IN THE FUTURE. CALL 800-883-2299 OR FILL OUT A CONFIDENTIAL FORM BELOW.