FDA Post-marketing Surveillance Of Power Morcellators And Other Medical Devices Lacks Guidance


Power Morcellator Cancer Lawsuits Have Long Alleged The Morcellation Deviced Used In Some Hysterectomies Can Spread Undetected Uterine Cancer

morcellator-lawsuit-Leiomyosarcoma-uterine-cancerMedical researchers say the U.S. Food and Drug Administration’s (FDA) post-marketing surveillance system for medical devices, such as power morcellators, needs improvement so safety issues can be identified sooner. In a “Viewpoint” published June 29 in the Journal of the American Medical Association (JAMA), researchers pointed to power morcellators that spread uterine cancer as an example of the FDA’s system lacking important post-market data that could have shown problems with the medical device.

Southern Med Law raised awareness of the cancer risks power morcellators posed to women before the FDA all but banned the device nearly three years ago. In 2014, the law firm filed the first federal morcellator cancer lawsuit against LiNA Medical APS, Kebomed AG and LiNA Medical. The firm represented a Pennsylvania widower whose wife underwent a robot-assisted hysterectomy in March 6, 2012, and was diagnosed with an aggressive uterine cancer nine days after surgery. Unfortunately, the woman died of disseminated leiomyosarcoma in February 2013. She was 53. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)

“As the debate over power morcellators continue, women are still suffering from the cancer they developed after having morcellation surgery,” says Dr. François Blaudeau, founder of Southern Med Law.

Southern Med Law continues to represent numerous women in morcellator cancer lawsuits against medical device manufacturers that include Ethicon Inc., Karl Storz, and LiNA Medical. The firm is dedicated to achieving justice for women who were harmed by power morcellators and other high-risk medical devices. If you suffered injuries from a power morcellator or other medical device and want to speak with one of the firm’s experienced attorneys, call 1-205-547-5525 or fill out a contact form on the firm’s website at www.southernmedlaw.com.

According to the June 29 JAMA editorial, what’s also missing when it comes to power morcellators is a “comprehensive system of data collection based on the experience of many thousands of women who have undergone” morcellation procedures. The FDA is not solely responsible for the lack of sufficient data regarding high-risk devices, according to researchers. The responsibility also lies with the “clinical community, which often resists requirements to report data; with manufacturers, which often oppose strong pre-marketing and post-marketing requirements; and with payers, which often do little with the major data assets that they control.” The “Viewpoint” was written by Dr. Joshua Sharfstin, of the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health, and Drs. Alison Jacoby and Rita Redberg, the University of California, San Francisco’s Department of Obstetrics and Gynecology. Dr. Redberg is also editor of JAMA Internal Medicine.

Laparoscopic power morcellators remove fibroids (myomectomy) and the uterus (hysterectomy) by shredding uterine tissue for removal through a small incision in the abdomen. Studies have shown the device spreads undetected cancer cells from the uterine tissues throughout the abdomen. A Government Accountability Office’s report issued earlier this year indicated the FDA’s “passive system” of reporting problems with power morcellators delayed the FDA from acting on reports of the device spreading uterine cancer in women.

Women who developed uterine cancer after having a hysterectomy or fibroid removal have been filing morcellator cancer lawsuits against medical device manufacturers, including Ethicon, Inc, Karl Storz, Richard Wolf, and Gyrus ACMI. After the FDA issued a warning about the device in 2014, Johnson & Johnson suspended global sales of power morcellators made by its subsidiary, Ethicon Inc.

About Southern Med Law And Filing A Morcellator Cancer Lawsuit

Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possess a deep understanding of the complex medical and legal questions at issue in all aspects of laparoscopic power morcellators. Southern Med Law is a full service law firm representing men, women and their families across the country who have been victims of negligence, personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526

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