A surgical device used in hysterectomies, myomectomies and other gynecological procedures is now linked to aggressive and fatal uterine cancer. The device, called a power morcellator, has been banned my top hospitals throughout the country and subject to cancer lawsuits. A group of surgeons, however, continues to defend the power morcellator. Our team of uterine cancer lawyers explores why doctors are standing behind this device.
The link between the morcellator and uterine cancer was publically exposed in 2013, when study after study confirmed the association. One of these studies, conducted by Columbia University, found that at least 1 woman out of every 370that undergo a hysterectomy using a power morcellator will have undetected cancer cells. During the procedure, these cancer cells are spread throughout the uterus, planting in previously healthy tissue and creating massive tumor cell spread.
This confirms the FDA warning, made in April 2014, discouraging the use of power morcellators in hysterectomies and myomectomies, or surgeries to remove uterine fibroids. Power morcellators work by shredding large masses of tissue inside the body, so the tissue can be removed through a minimally-invasive incision. It was recommended to patients who were looking for shorter recovery times and less scar tissue.
The problem with this method is the likelihood that the tissue will contain undetected cancer cells – specifically, the cancer uterine leiomyosarcoma. This is an extremely aggressive form of cancer, and many women have been diagnosed with Stage 4 uterine leiomyosarcoma just weeks after morcellation procedures. There is no test to detect these cancer cells before surgery.
During an FDA hearing on power morcellators in July 2014, however, many gynecologists and surgeons said they still believed the benefits of morcellation surgery outweighed the risks. The American Association of Gynecologic Laparoscopists (AAGL) later released a report saying morcellation remains safe “when performed by experienced, high-volume surgeons.”
Like most other issues in healthcare, there were outside influencing factors at play here. One of the AAGL executive officers, Arnold Advincula, who had considerable say in the report, received “consulting fees” (or more simply, cash) from a morcellator manufacturer. Specifically, Advincula – who is now the AAGL president – has received at least $50,000 in the last year for consulting services with Blue Endo, which sells power morcellators.
The former president of the AAGL, Andrew Brill, has also done considerable “consulting” for morcellator companies. He chose to step down from the FDA morcellator panel in July 2014. More than 7,500 gynecologists read reports from the AAGL closely for guidance on best practices.
Yet another former AAGL president, Ceana Nezhat, recused himself from the morcellator report due to his own financial ties with a morcellator manufacturer. He neither voted on nor discussed the report with the other AAGL members. He also requested that Advincula do the same, to no avail. After the report was published, Nezhat sent an email stating that it was misleading and that the AAGL needed a zero-tolerance conflict of interest policy.
Since its release, the AAGL report has been used to credit the use of power morcellators and even persuade hospital administrators to continue offering morcellation surgeries.
Despite this report, the FDA has repeatedly warned doctors not to use morcellators on women, and most hospitals have stopped using them in gynecologic procedures. Johnson & Johnson, a major maker of power morcellators, pulled its devices from global markets.
Our team of uterine cancer lawyers is currently investigating cases of cancer development or progression from procedures using this device. We understand that women may not know whether or not morcellators were used during their hysterectomy or fibroid removal. We are able to order all medical records for you, investigate the procedural notes, and determine whether or not you have a case, all free of charge. We only get paid if we win you a settlement or verdict.
It is also important to note that these lawsuits are NOT against the doctors or hospital that performed your procedure; rather, these are product liability lawsuits, filed against the companies that designed, manufactured and sold power morcellators, such as Johnson & Johnson or Endo Blue.