August 1st, 2014|
On July 30, 2014, The Wall Street Journal reported Johnson & Johnson (J&J) will be withdrawing their morcellator devices. This means J&J and their Ethicon unit will now be asking doctors and hospitals to return all of their unused morcellators. The morcellator works by grinding up tissue into smaller pieces during laparoscopic and robotic gynecological surgery for removal through small incisions. If the tissue being removed contains undiagnosed cancer, like uterine sarcoma, the process of morcellation can spread cancer cells to normal tissues. The FDA previously estimated the risk of undiagnosed uterine sarcoma could be as high as one in 350. The spreading of cancer cells can understandably worsen a woman’s chance of survival. The FDA’s concerns were strengthened when a Research Letter was published by JAMA on July 22, 2014, showing 27 in 10,000 women undergoing morcellation.
In April, J&J stopped selling their morcellators after the FDA advised doctors to stop using this device. On July 10th & 11th, 2014, the FDA held a two-day meeting to discuss the risks and benefits of this device. The meeting included presentations from affected patients and family members, doctors who were for and against the device, experts in the field of cancer diagnosis as well as morcellator manufacturers. The FDA has not yet published their conclusions and recommendations.
According to an article in Tech Times on July 31, 2014, Matthew Johnson, a J&J/Ethicon spokesman is quoted: “Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon Morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
Link to The Wall Street Journal article of July 30, 2014: http://www.wsj.com/news/article_email/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350-lMyQjAxMTA0MDMwMTEzNDEyWj
Link to the JAMA Research Letter dated July 22, 2014: http://jama.jamanetwork.com/article.aspx?articleid=1890400&resultClick=3
Link to the FDA website with meeting materials from the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting:http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm404143.htm
Link to the FDA’s Safety Communication of April 17, 2014:
Link to the Tech Times article of July 31, 2014: http://www.techtimes.com/articles/11735/20140731/johnson-johnson-recalls-hysterectomy-power-morcellator-that-may-spread-cancer.htm