The California product liability attorneys at Cutter Law P.C. are investigating claims involving power morcellators (LPM), a medical device used during certain laparoscopic surgeries, including myomectomies and hysterectomies.
The device aggressively cuts uterine tissue into small pieces so it can be removed from a small incision site, avoiding long surgical scars that occur with traditional, more invasive surgery. The alleged benefits of using a power morcellator include shorter recovery periods, less pain and fewer complications.
In April 2014, the U.S. Food and Drug Administration (FDA) issued a safety alert after a rise in adverse reports. The alert discouraged the use of these devices for uterine and fibroid removal surgeries because of the possibility that they may spread undetected or unsuspected uterine cancer known as sarcoma.
From the FDA safety alert (April 14, 2014): “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” The FDA suspects that an estimated one in 350 women who undergo one of these procedures may have undiagnosed uterine cancer.
On July 30, 2014, Ethicon, a subsidiary of Johnson & Johnson, voluntarily withdrew its devices and suspended worldwide sales of power morcellator models including Gynecare Morcellez, Gynecare X-Tract and Morcellex Sigma. Hospitals around the country have suspended use of the morcellator, and many insurance carriers will no longer cover procedures involving the device.
On Nov. 24, 2014, the FDA revised its safety communication and recommended that the product receive a new box warning to more accurately inform health care providers and patients of the potentially serious side effects.
Allegations Against Johnson & Johnson
In June 2014, the Pittsburgh Times published an article alleging that Johnson & Johnson may have been aware of the serious risks associated with power morcellators since 2006, eight years before the manufacturer suspended sales of the device.
Dr. Robert Lamparter, who worked as a pathologist at Evangelical Hospital for 28 years, began noticing a higher incidence of post-surgical malignancies after procedures in which a morcellator was used to remove the uterus or uterine fibroids.
In 2006, Dr. Lamparter sent an email to Johnson & Johnson in which he suggested that the presurgical screening methods for cancer could potentially miss a number of malignancies, which could subsequently spread if a morcellator was used in the procedure.
In the article from the Pittsburgh Times, Dr. Lamparter was quoted as saying, “I believe there’s more risk to this procedure than J&J realizes because of the way Community Hospital gynecologists are screening patients.
Our pathology group agrees that at least once in a year’s time, we find an unexpected malignancy in a uterus that takes a gynecologist by surprise. Virtually all uteruses have some sort of pre-op screening, whether it’s an endometrial biopsy or an ultrasound, so whatever screening is being done misses a certain number of malignancies.
When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
Dr. Lamparter said that he received a response back from Dr. David Robinson, then medical director of Ethicon Women’s Health and Urology. Dr. Robinson suggested they could add a warning to its instructions for use of the device and that Dr. Lamparter’s concerns would be addressed by Ethicon’s customer quality department.
In early April 2006, Dr. Robinson followed up with Dr. Lamparter, informing him that a warning would be added to the device’s instructions saying “Using a morcellator when a uterine tumor was present may lead to the dissemination of the malignant tissue.”
In May 2006, Ethicon officially closed the file on Dr. Lamparter’s complaint. Unsatisfied with the company’s response, Dr. Lamparter followed up with another email requesting that it reconsider, saying the morcellator is “probably a good product and innovation, but the surgical users need some education with regard to its potential to inadvertently do harm.”
Dr. Lamparter never received a response.
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Cutter Law P.C. represents clients throughout California and nationwide.
If you or a loved one has undergone surgery for a hysterectomy or myomectomy in which a power morcellator was used, you may be eligible to file a morcellator lawsuit.
Call toll free at 888-285-3333 or schedule a free case evaluation.