Of interest to anyone who has had surgery and developed cancer following laparoscopic surgery with a power morcellator is recent news linking its use to newly diagnosed cases of various cancers. Due to the efforts of married physicians Dr. Amy Reed and Dr. Hooman Noorchashm to ban the use of electric morcellators the FDA began studying its link to its cancer risk in December of 2013. The power morcellator is a tissue cutting device that was approved for gynecologic surgeries over twenty years ago. Gynecologists initially hailed the use of the morcellators as a medical advance that would make hysterectomies or removal of fibroids less invasive due to being able to avoid the traditional major surgery of cutting open the abdomen. Morcellated uterine tissue which was cut up could be removed through small incisions lessening the need for long hospital stays, the risk of complications and long recovery times.
In 2013 Dr. Reed's undetected uterine cancer was spread due to the use of a power morcellator. Unfortunately there is the potential danger that the tissue fragments generated by the use of the power morcellator may accelerate the spread of uterine cancer to other areas of the body. Largely, due to her and her husbands efforts in 2014 the FDA did warn that the device could spread and worsen uterine cancer and recommended that the device not be used in the majority of cases since it determined the risk to be 1 in every 350 women who undergo hysterectomy or fibroid surgery. The GAO, which investigates how the government spends tax dollars said its investigation uncovered 30 medical journal articles between 1980 and 2013 which mentioned the risk of spewing tissue fragments while using a power morcellator. Despite these findings the FDA previously assumed the risk was low and "were not aware of any definitive scientific findings regarding the actual risk of cancer in uterine fibroids." Until Reed and Noorchashm brought the situation to light, gynecological surgeons who informed women of the potential risks were under the erroneous impression that the likelihood of spreading cancers were 1 in 10,000. The recent troubling findings have lent further credence to lawsuits stemming from the use of the morcellators. To date, there has been no comment by the American College of Obstetricians and Gynecologists and the Society of Minimally Invasive Gynecological Surgeons on the GAO report.
Dr Noorchashm has recently expressed concern in his recent statement, "there are sure to be other hazardous devices causing unreasonable harm to American patients as a result of the failures defined by the report", calling for "immediate formal attention" by Congress and the Trump administration.
A number of companies have manufactured these devices including Lumenis, Olympus, Smith and Nephew, LINA, Blue Endo, Ethicon/Johnson & Johnson, Cook Urological Inc. and Richard Wolf GmbH. Three of the companies, Ethicon, LiNA, and Blue Endo have been the subject of lawsuits regarding injuries or deaths caused by the alleged development of cancer after power morcellator devices were used in hysterectomy procedures. The type of cancers cancers allegedly caused or spread by power morcellators include carcinoma, endometrial stromal sarcoma, leimyosarcoma and endometrial adenocarcinoma.
If you or someone you know whose health has been harmed due to the the use of a power morcellator or other medical device you may be entitled to compensation. It is important you talk to an attorney so you can be advised of your legal rights. Contact us online or call 1-888-435-7946 (888-HELPWIN) for a free consultation. We serve all of the state of Pennsylvania from our offices in Philadelphia, Reading and Bala Cynwyd. There is never a charge to speak with us about your legal rights.