J&J Stops Sale of Laparoscopic Power Morcellators Used in Fibroid Surgery
Amid concerns over the potential to spread undetected cancer beyond the uterus, Johnson & Johnson (J&J) has suspended the sale of its power morcellators until their role in fibroid treatment is better understood. Laparoscopic power morcellation uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen. The withdrawal follows an FDA warning that discouraged the use of laparoscopic power morcellators to remove fibroids because of a risk of spreading hidden cancer (see below) . J&J is not recalling the device because power morcellation may still be the best option for some patients after risk evaluation and informed consent.
 Reuters, "J&J suspends sale of device used in fibroid surgery," April 30, 2014.
FDA Warns That Laparoscopic Power Morcellators Used in Hysterectomy and Fibroid Removal May Spread Cancerous Tissue
The FDA has issued a new warning about laparoscopic power morcellators, the medical devices used during minimally invasive surgeries such as hysterectomy and uterine fibroid removal. Morcellation is the process by which the tissue is divided into smaller pieces or fragments in order to remove it through the small incision sites. The FDA reports that when used for hysterectomy or fibroid removal, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue beyond the uterus.
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids at some point, but most fibroids cause no symptoms. In some cases, however, fibroids can cause symptoms including heavy or prolonged menstrual bleeding, pelvic pain, and/or frequent urination, requiring medical therapy or surgery.
Women often choose laparoscopic surgery over traditional abdominal surgery because of the shorter recovery time and reduced risk of infection. However, if there is an unsuspected uterine cancer, the process of breaking up the tissue to remove from the small incision may spread cancerous tissue. Therefore, the FDA is now discouraging the use of laparoscopic power morcellation during hysterectomy and the removal of uterine fibroids and is encouraging doctors and patients to carefully consider alternative treatment options.
 FDA Safety Communication, "Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication," April 17, 2014.
Recall: da Vinci Cannulae Used with Robotic Surgery Device
Intuitive Surgical is voluntarily recalling certain lots of Single-Site® 5mm Reusable Curved Cannulae because incorrect placement of the cannulae in the Single-Site port could potentially cause damage. If it becomes damaged during surgery, there is the possibility that the cannula or instrument may come in inadvertent contact with tissue. In addition, the surgeon may need to replace the damaged cannula during surgery or convert to a multi-port approach if another cannula is not available.
The da Vinci Surgical System is a medical robotic technology used for minimally invasive surgery. When used according to instructions, the cannulae are unlikely to become damaged. The total reported cannulae damage occurrence rate is approximately 0.52%. In addition to the recall, Intuitive Surgical is revising its Single-Site labeling to instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
Affected lots were manufactured between December 2010 and August 2012. All affected cannulae will be replaced with a new version that can withstand higher force and is less likely to become damaged by incorrect placement. For more information see intuitivesurgical.com.
 Intuitive Surgical "Important Product Information" (March 26, 2014).
Medical Safety News: FDA Surveys Surgeons Using Da Vinci Surgical System
The FDA has issued a final report on the small sample survey of surgeons who use the da Vinci Surgical System. The survey was conducted to better understand the challenges of the system versus conventional surgical procedures. The da Vinci Surgical System is a computer-assisted device designed to facilitate minimally invasive surgery. All surgeons reported that learning to use the system was the biggest challenge. Reported benefits of the system included fewer patient complications and shorter hospital stays. Suggestions for improving the system ranged from changes in the system design and training, to mounting the device on the ceiling to allow more space in smaller rooms.
 FDA, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Medical Product Safety Network, Small Sample Survey - Final Report, Topic: da Vinci Surgical System (November 2013).
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