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Summer 2020ANDA Approvals
Power Morcellators
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By accepting these terms, you are confirming that you have read and understood this important notice.
On April 17, 2014 the FDA cautioned that power morcellators, a type of surgical tool used in laparoscopic and robotic hysterectomies and fibroid removal procedures, may promote the spread of unsuspected uterine cancer. In response, Johnson & Johnson, the largest manufacturer of the devices, suspended worldwide sales of its laparoscopic power morcellators.
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that 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 FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. The FDA is now urging doctors to avoid using power morcellators during uterine fibroid treatments.
Robins Kaplan LLP is interested in speaking with individuals who have undergone a power morcellation hysterectomy or fibroid removal procedure and were then diagnosed with uterine cancer, endometrial cancer, leiomyosarcoma, uterine sarcoma, or another cancer that has spread throughout the body.
Robins Kaplan LLP is experienced with medical device suits and is dedicated to giving our clients a voice against large companies. We welcome calls from referring attorneys or potential clients. Contact us at 1.612.349.8500 or 1.800.553.9910
[2] Wall Street Journal, Johnson & Johnson Suspends Sale of Device Used in Fibroid Surgery, April 29, 2014, http://online.wsj.com/news/articles/SB10001424052702304893404579531961812995326
[3] http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm
[4] Id.
[5] Id.
[6] Id.
[6] Id.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.