The first federal lawsuit involving laparoscopic power morcellators was filed in the Eastern District of Pennsylvania against LiNA Medical on March 14, 2014 by the family of Donna Burkhart. The lawsuit alleges that the morcellator manufacturer failed to adequately warn surgeons of the risk of disseminating cancer following the use of the device, failed to design a safer "closed" system that would prevent the spread of cancer cells, and failed to act when studies revealed that disseminating cancer was occurring. In 2012 Mrs. Burkhart had a hysterectomy in which a power morcellator was used and she died of uterine cancer less than a year later.
In April, the FDA issued a strong warning against using power morcellators during laparoscopic uterine surgery because of the risk of inadvertently spreading uterine cancer cells throughout the abdominal cavity (MedWarn, 4/17/2014). Morcellators are used in about 10% of the 600,000, hysterectomies performed in the U.S. each year.
A state lawsuit filed in New York on May 1, 2014, accuses Johnson & Johnson subsidiary Ethicon of substandard testing of its Morcelex morcellation device. The plaintiff in that case was diagnosed with cancer after a hysterectomy assisted by the laparoscopic power morcellator in 2012. According to the plaintiff, Ethicon knew about the risk of dissemination of cancer but failed to provide hospitals with potential safety precautions such as a reinforced intra-peritoneal bag to avoid spillage of unsuspected cancer cells.
Johnson & Johnson suspended sales of its laparoscopic power morcellators, but did not recall the devices because it maintains the devices may be the best option for some patients after risk evaluation and informed consent (MedWarn, 5/02/2014).
While the trouble with power morcellators continues, another company is poised to market what could be a better option for uterine surgeries. On May 8, Boston Scientific announced a $65 million acquisition of loGyn, a company that makes Symphion, an FDA-approved system for hysteroscopic intrauterine tissue removal. The recirculating Symphion system evacuates the tissue under suction, which may prove to be a safer alternative to power morcellators.
[1] J&J Stops Sale of Laparoscopic Power Morcellators Used in Fibroid Surgery, MedWarn Alerts, 05/02/2014.
[2] FDA Safety Communication, "Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication," April 17, 2014
[3] FDA Warns That Laparoscopic Power Morcellators Used in Hysterectomy and Fibroid Removal May Spread Cancerous Tissue, MedWarn Alerts, 04/17/2014.[4] Burkhart v. LiNA Medical US et al., No. 5:14-cv-1557, complaint filed (E.D. Pa., Allentown Mar. 14, 2014).
[5] Baker, R., "Woman died of cancer spread by surgical tool, husband says," Thomson Reuters, March 26, 2014.
[6] Leuzzi et al. v. Ethicon Endo Surgery, Inc., d/b/a Ethicon Womens Health and Urology et al., No. 6:14-cv-06218 (N.Y. Western, May 1, 2014).
[7] Sarvestani, A., "FDA morcelator warning spurs lawsuit against J&J," MassDevice, May 7, 2014.
[8] Boston Scientific Press Release, "Boston Scientific to Acquire Iogyn, Inc.," May 6, 2014.
In April, the FDA issued a strong warning against using power morcellators during laparoscopic uterine surgery because of the risk of inadvertently spreading uterine cancer cells throughout the abdominal cavity (MedWarn, 4/17/2014). Morcellators are used in about 10% of the 600,000, hysterectomies performed in the U.S. each year.
A state lawsuit filed in New York on May 1, 2014, accuses Johnson & Johnson subsidiary Ethicon of substandard testing of its Morcelex morcellation device. The plaintiff in that case was diagnosed with cancer after a hysterectomy assisted by the laparoscopic power morcellator in 2012. According to the plaintiff, Ethicon knew about the risk of dissemination of cancer but failed to provide hospitals with potential safety precautions such as a reinforced intra-peritoneal bag to avoid spillage of unsuspected cancer cells.
Johnson & Johnson suspended sales of its laparoscopic power morcellators, but did not recall the devices because it maintains the devices may be the best option for some patients after risk evaluation and informed consent (MedWarn, 5/02/2014).
While the trouble with power morcellators continues, another company is poised to market what could be a better option for uterine surgeries. On May 8, Boston Scientific announced a $65 million acquisition of loGyn, a company that makes Symphion, an FDA-approved system for hysteroscopic intrauterine tissue removal. The recirculating Symphion system evacuates the tissue under suction, which may prove to be a safer alternative to power morcellators.
[1] J&J Stops Sale of Laparoscopic Power Morcellators Used in Fibroid Surgery, MedWarn Alerts, 05/02/2014.
[2] FDA Safety Communication, "Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication," April 17, 2014
[3] FDA Warns That Laparoscopic Power Morcellators Used in Hysterectomy and Fibroid Removal May Spread Cancerous Tissue, MedWarn Alerts, 04/17/2014.[4] Burkhart v. LiNA Medical US et al., No. 5:14-cv-1557, complaint filed (E.D. Pa., Allentown Mar. 14, 2014).
[5] Baker, R., "Woman died of cancer spread by surgical tool, husband says," Thomson Reuters, March 26, 2014.
[6] Leuzzi et al. v. Ethicon Endo Surgery, Inc., d/b/a Ethicon Womens Health and Urology et al., No. 6:14-cv-06218 (N.Y. Western, May 1, 2014).
[7] Sarvestani, A., "FDA morcelator warning spurs lawsuit against J&J," MassDevice, May 7, 2014.
[8] Boston Scientific Press Release, "Boston Scientific to Acquire Iogyn, Inc.," May 6, 2014.
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