However, the U.S. Food & Drug Administration has recently placed an advisory on one of the company's products, the Ethicon morcellation device, used to remove uterine fibroids. The FDA notice was issued to all manufacturers of the device.
What Are Uterine Fibroids?
Uterine fibroid growths are a common problem in women. These fibroids are non-cancerous growths that develop in the smooth muscle tissue that lines the uterus. Their growth can cause a variety of troubling symptoms for women that can impact quality of life. Treatment includes removal of the growths by a number of procedures.
What Are Ethicon Morcellation Devices?
Laparoscopic power morcellation uses a small device to divide uterine tissue into smaller fragments so it can be easily removed through the small abdominal incision. The Ethicon device offered a more efficient way to break up fibroid growths for more complete removal. However, studies began to indicate that the product also had the effect of spreading undiagnosed cancer more widely into the body.
The U.S. Food & Drug Administration reviewed studies that indicate approximately 1 in 350 women who undergo myomectomy procedures for fibroids or hysterectomies have a type of undetected uterine cancer known as uterine sarcoma. The risk of spreading this type of cancer by use of laparoscopic power morcellation prompted the agency to begin discouraging use of the device.
Because neither the patient nor the physician may be aware of the presence of cancerous cells at the time of the procedure, the risks of dislodging cells and facilitating metastatic growth in other parts of the body caused the agency to recommend the use of other treatments before resorting to use of the device. A thorough discussion of the risks and benefits of the morcellation device is also indicated. Those who have undergone the procedure should stay in contact with their physicians and be alert to any changes in symptoms.
J & J Stops Sales
In April of 2014, Johnson & Johnson suspended sales of the Ethicon morcellation device worldwide. They re-stated the device has always included warnings about the possible spread of malignant tissue during use of the device. They previously chose not to remove the device from use, because the FDA maintains that power morcellation can still be the best method for some patients after careful evaluation.
Company Outlook For 2014
J&J has taken assertive measures to manage the medical device problem, which should help minimize fallout from questions about its use.
Though the FDA clearly feels more caution should be used by medical professionals using the device, the agency fell short of issuing a Class I recall.
JNJ is engaged in the research and development od a broad range of products in the health care field. The business of JNJ is conducted by more than 275 operating companies in 60 countries which sell products in virtually all countries in the world. While impossible to quantify, the FDA advisory on this one product should have minimal impact of the JNJ results for 2014.
JNJ's additional products, including leaders Olysia, Imbruvica, and Invokana, will likely continue to drive growth. It is estimated these eventually earn JNJ a combined $7 billion or more.
JNJ continues to pay increasing, healthy dividends to its shareholders.
We reiterate out positive outlook on JNJ in 2014, despite the current suspension for Ethicon morcellation devices.
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