Morcellator Recall Information
Laparoscopic Power Morcellators Subject to Global Recall for Cancer Risk
Laparoscopic power morcellators were recalled from hospitals globally in July of 2014 when new studies suggested the device has the potential to cause severe harm. In particular, power morcellators used for hysterectomy and myomectomy can spread unsuspected cancer cells throughout the patient’s abdomen. This results in cancer “upstaging”, meaning a relatively treatable disease is advanced to a late-stage and often deadly cancer through the process of morcellation. In response to FDA warnings, Johnson & Johnson has issued a comprehensive morcellator cancer recall. J&J dominates sales of power morcellators for hysterectomy and myomectomy in the U.S. and throughout the world.
The J&J morcellator recall represents yet another major product safety recall from one of the largest medical suppliers in the nation. “The company has had a rather abysmal track record on the public health front of ethical breaches in the last few years,” according to Diana Zuckerman, President of the National Center for Health Research. Late in 2013, J&J announced it would pay a total of $2.5 billion to settle 8,000 hip implant recall cases resulting from product defects in its DePuy Orthapaedics line. J&J is currently facing approximately 30,000 lawsuits for defective pelvic mesh implants. Despite these setbacks, J&J increased sales during 2013 by 6.1%, reporting annual sales of $71.3 billion.
Filing a morcellator cancer recall lawsuit against Johnson & Johnson may be the most effective method for consumers to demand corporate accountability for the injustices done to women who have developed late-stage cancer as a result of surgery. This page contains comprehensive information about the morcellator cancer recall and resources for filing a morcellator recall lawsuit.
Morcellator Cancer Recall History
The morcellator cancer risk became public knowledge through a series of events in 2014, but Johnson & Johnson knew of the risk as early as 2006. That year, Dr. Richard Lamparter, a pathologist at Evangelical Community Hospital in Lewisburg, PA, informed Johnson & Johnson of the risk posed by power morcellators for spreading unsuspected uterine cancer. At that time, eight years before the company withdrew power morcellators from the market and issued a global morcellator recall, the company added a minimal warning to the product label. The warning cautioned surgeons that unsuspected ovarian sarcomas (cancer) may be present. However, the label did not outline the risk posed by using morcellation when such cancer cells did exist.
When Dr. Lamparter contacted J&J in 2006, he indicated that traditional open surgery was a safer alternative to morcellator surgery:
“When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
In fact, the FDA confirmed Lamparter’s statement in 2014: “Patients with unsuspected sarcoma who undergo morcellation may have poorer disease-free survival and overall survival compared to patients who do not receive morcellation.”
Dr. Lamparter is not the only physician who has spoken out publicly to warn of the cancer danger. Dr. Hooman Noorchashm of Harvard launched a large-scale effort to ban the device in hysterectomy and myomectomy, resulting in the morcellator recall. Noorchashm asserts that using morcellators for hysterectomy is “a shameful act of professional negligence” because of the potential to spread and intensify existing cancer. Because there is no reliable way to know if cancer cells are present prior to surgery, Dr. Noorchashm called for a widespread ban on the practice.
Dr. Noorchashm asserts that using morcellators for hysterectomy is “a shameful act of professional negligence” because of the potential to spread and intensify existing cancer.
Dr. Noorschashm’s online petition, and the high-profile plight of his anesthesiologist wife who was diagnosed with advanced-stage ovarian cancer following a hysterectomy, brought the attention of federal regulators to the issue. In April of 2014, the FDA issued a Safety Communication warning surgeons against the use of power morcellators for ovarian surgeries due to a higher-than-presumed risk of spreading cancer. Shortly thereafter, J&J’s Ethicon division suspended the sales and marketing of these devices worldwide. This action conceded that morcellator cancer was a real threat, but fell short of a morcellator recall. Johnson & Johnson is the primary manufacturer of power morcellators used for gynecologic surgeries.
Then, in July of 2014, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to more fully investigate the risk of morcellator cancer. Through a review of literature and adverse events reporting, the committee concluded that the spreading of cancerous cells and intensification of the disease is a serious risk for patients undergoing surgery and called for stronger cancer warnings on product labels.
J&J Issues Morcellator Recall for Cancer Risk
On July 30, 2014, in the wake of the FDA medical device committee's findings, Johnson & Johnson issued a global morcellator recall for all laparoscopic power morcellators used in gynecologic surgeries such as hysterectomy and myomectomy. The company sent a letter entitled “Urgent: Medical device market withdrawal” to hospitals around the United States, warning surgeons of the morcellator cancer risk and asking that power morcellator devices be taken out of use and returned to the company promptly. The J&J morcellator recall is for three different products: the Gynecare Morcellex, the Gynecare X-Tract, and the Morcellex Sigma. The J&J morcellator recall for cancer has highlighted the morcellator cancer risk in both the medical community and amongst the public.
Morcellator Recall Lawyers Help Women and their Families
Our attorneys representing families in morcellator recall lawsuits have expertise in the realm of medical device litigation. They will work tirelessly to achieve justice on behalf of women and families of women who have been diagnosed with cancer following surgery with a device subject to the morcellator recall. If you or your mother, spouse, or other loved one developed cancer after having a gynecologic surgery such as hysterectomy or myomectomy, a morcellator recall attorney can help by answering your questions and giving you a sense of your legal options.
Morcellator Recall Lawsuits
Women who were diagnosed with cancer following a hysterectomy or myomectomy may have grounds for a morcellator recall lawsuit. Our attorneys provide legal representation for morecellator recall lawsuits on contingency basis, meaning they never charge a fee unless they win compensation on your behalf.