Boston, MA 05/02/2014 (wallstreetpr) – Johnson & Johnson (NYSE:JNJ), engaged in R&D, production and sale of a wide range of products in the health care field has decided to halt the sales of devices that are used to remove the growth in the uterus.
FDA issues advisory to doctors
Food and Drug Administration has recently issued an advisory to doctors to avoid the use of laparoscopic power morcellators. The device is used by surgeons for the treatment of painful fibroids by removal of the growth or the whole uterus. The device helps to cut and remove the tissue using a blade. It helps to remove by making a small cut in the abdomen rather than a big opening made in the traditional surgery. The decision has been taken after the government issued a warning about the electronic surgical tools spreading cancer to other parts of the body.
Laparoscopic power morcellators can cause cancer
According to the FDA, there is a great risk that the device can crush undetected uterine tumors and spread the cancer to the pelvis, abdomen and other regions. Hysterectomy is the leading treatment because it is the only way to ensure that fibroids do not return. Out of 600K women in the US undergoing hysterectomy, 50K use the power morcellation technique. The analysis shows that 1 out of every 350 women undergoing the fibroid procedure has been detected with the cancer called uterine sarcoma. Fibroids are non-cancerous growths that can cause severe pain, heavy bleeding, and bladder and bowel dysfunction in the uterus. Johnson & Johnson has always cautioned the doctors about this risk.
A waiting game for Johnson & Johnson
Johnson & Johnson (NYSE:JNJ) is waiting for clarification from regulators and the medical community regarding morcellation and fibroid treatment as it is considered to be the best option for the patients. The FDA has called a meeting of its advisory committee to discuss the role of gynecological medical devices like laparoscopic power morcellation for the treatment of uterine fibroids. The sale, distribution and promotion of Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract devices will be temporarily suspended.
