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(Medical-NewsWire.com, May 24, 2014 ) New York, NY -- Johnson & Johnson announced that it was suspending the promotion, sales and distribution of laparoscopic power morcellators due to concerns that the medical device spreads uterine cancer in women. The company’s move came nearly two weeks after the U.S. Food & Drug Administration (FDA) warned that power morcellators can potentially spread cancer during gynecological surgeries on women. The federal agency estimates that one in 350 women undergoing a hysterectomy or myomectomy to remove uterine fibroids has undetected uterine cancer, and using power morcellation could shorten their chances of survival.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm]
Reuters reported that Johnson & Johnson will not completely take laparoscopic power morcellators off the worldwide market since the FDA maintained that morcellation may be the best option for some patients who consent to having the medical device used in a procedure after they have been notified of the risk involved. However, the company will halt the sale of the medical devices until the power morcellators role in treating fibroid tumors is better understood and redefined by the medical community. A Johnson & Johnson spokeswoman told the news agency the company is also notifying regulatory agencies around the globe of its plans.
Reuters also reported that Johnson and Johnson wrote its intentions in a letter to its customers regarding the suspension of its laparoscopic power morcellation devices, which is used in fibroid surgery to divide uterine tissue into fragments that can be removed through a small incision in the abdomen.
[ reuters.com/article/2014/04/30/us-johnson-johnson-device-idUSKBN0DG06G20140430, April 30, 2014 ]
According to court documents, a Berks County, Pennsylvania man filed a federal lawsuit on behalf of his wife died of an undiagnosed sarcoma after she underwent a hysterectomy in March 2012 in which a laparoscopic power morcellation device was used. The complaint indicates that the 53-year-old woman died in February 2013, of metastatic leiomyosarcoma, a rare form of soft tissue cancer. The morcellation lawsuit, filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania, names as defendants Ethicon Inc., a subsidiary of Johnson & Johnson, Blue Endo and Lina Medical, all of which manufacturers morcellators.
(Case No. 5:14-cv-1557)
Prior to the FDA’s warning concerning laparoscopic power morcellators, a Boston couple launched a campaign in 2013 in an effort to get medical professionals to stop using morcellation. The 41year-old involved in the campaign, who is an anesthesiologist, underwent a hysterectomy and morcellation was used in the procedure, according to an ABCNews.com report. The woman was diagnosed with stage IV leiomyosarcoma cancer after her surgical procedure and the hospital where she had the surgery acknowledged that the morcellator made the disease worse.
ABCNews.com further reported that the woman and her husband, who is a surgeon, contacted politicians and members of the health care community, and collected nearly 8,000 signatures for a petition to get medical professionals to stop using laparoscopic power morcellation.
[abcnews.go.com/Health/couple-campaign-stop-surgical-procedure-applauds-fda-decision/story?id=23369823, April 17, 2014]
About Alonso Krangle LLP
Andres Alonso And David Krangle, Attorneys With Almost 40 Years Of Collective Legal Experience, Have Focused Their Law Practice On The Handling Of Significant Personal Injury Cases, Defective Drug And Medical Device Litigation, Construction Site Accidents,Nursing Home Abuse, Medical Negligence, Qui Tam/Whistleblower Actions And Consumer Fraud Cases. A Nationwide Law Firm Representing Injured Victims Throughout The U.S., Alonso Krangle Llp Is Headquartered In Long Island, New York, With Offices In New York City, And New Jersey. To Discuss Filing A Morcellator Lawsuit, Please Contact Alonso Krangle Llp At 1-800-403-6191 Or Visit Our Website, Http://Www.Fightforvictims.Com
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