W&L Resolves to Get Justice for Women Harmed By Power MorcellatorsJuly 30th, 2014
A devastating new study published in a leading medical journal reaffirms the growing body of literature that suggests power morcellators pose a cancer-spreading threat much worse than previously recognized.
Appearing in the authoritative Journal of the American Medical Association, the study paints use of power morcellators as flatly ill-advised, as the authors found the likelihood of a woman having an occult cancer to be as high as 1 in 368, with increasing risk positively correlated with age.
The authors, all from the Department of Obstetrics and Gynecology at Columbia University’s College of Physicians and Surgeons, recommend that women preparing to undergo minimally invasive hysterectomies and myomectomies for symptomatic uterine fibroids “should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.”
The study also confirms for us here at Weitz & Luxenberg that the makers of power morcellators need to be held accountable under the law for the harm caused to women treated with the devices.
“Our intent is to advocate for the legal rights of women stricken by cancer due to use of power morcellation,” said Paul Pennock, who heads the W&L attorney team that has been investigating injuries attributable to the devices.
Morcellators Scrutinized by Medical Panel
The JAMA study convinces us that our attendance at the U.S. Food and Drug Administration’s special hearing on power morcellators, held July 10-11 in Silver Spring, Maryland, was necessary and vital.
W&L science researcher and analyst, Eliana Epstein, attended the meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Committee on behalf of the firm.
The panel convened to weigh the risks and benefits of laparoscopic power morcellators.
It heard presentations from clinicians, laparoscopic power morcellator manufacturers, patient advocacy and research groups, and medical professional societies.
Exceptionally emotional were those given by affected patients and family members. Ms. Epstein said, “They shared horrifying and heart-wrenching personal stories.
“Many patients and family members who spoke, including the many doctors present, vehemently asserted that they were never warned about the use of a power morcellator during their surgery, or its inherent risks.
“The Panel and FDA were quite obviously moved by this testimony, and by data presented by researchers and clinicians, and recommended swift action on a practice that is, as Panelist Dr. Craig D. Shriver, Colonel and Director of the John P. Murtha Cancer Center at Walter Reed National Military Medical Center put it, ‘anathema to the core of cancer care.’ Indeed, Dr. Shriver called for a ban on power morcellators entirely.”
Problems Caused by Morcellators
A power morcellator is a surgical device with rapidly rotating blades employed to slice the uterus or uterine fibroids into small pieces for extraction via laparoscope suctioning.
Studies show that power morcellators can cause cancerous tissues known as uterine sarcomas hidden within fibroids to be spread throughout the abdominal cavity. Fibroids, a very common uterine growth found in many women, can be benign or malignant —there is no way to definitely tell until they are evaluated in the lab.
Additionally, power morcellators can cause the spread of even benign fibroid or uterine tissue throughout the abdominopelvic cavity, potentially causing growths, pain, infection or bowel obstruction as the tissue adheres to and grows on other organs.
Many clinicians and hospitals recognize that power morcellators endanger women. In fact, several hospitals have suspended use of the devices pending the FDA’s review of the Advisory Committee’s recommendations. The JAMA study reaffirms estimates of occult cancer risk published by the FDA in its Quantitative Assessment of the medical literature, released in a Safety Communication recommending against the use of power morcellators. It found risk of occult sarcoma to be 1 in 352, and risk of occult leiomyosarcoma, a particularly aggressive sarcoma, to be 1 in 498.
In the JAMA study, researchers looked at nearly 36,500 cases involving women having minimally invasive hysterectomies in which a power morcellator was utilized. The authors estimated that out of every 368 women subjected to power morcellation there will be one likely to emerge from surgery with cancerous tissues dispersed throughout her abdomen. This risk is in keeping with the estimates provided by the FDA in its Quantitative Analysis.
Contraindications of Morcellator Use
The Panel’s discussions were productive, and forceful.
The Panel recommended contraindications for power morcellator use. Based on the recommendations, power morcellation should not be used if the patient is:
- A peri- or post-menopausal woman presenting with new or symptomatic fibroids
- Suspected or known to have malignancy
The JAMA study could aid in the addition of one more contraindication: that power morcellators should not be used on women who are 50 years old and older, since advancing age is the biggest risk factor for uterine cancer.
As for indications, the panelists reached a consensus that power morcellation could be appropriate despite its risks in two special cases:
The first is the case of an older woman with vaginal prolapse scheduled to have a supracervical mesh anchored to the cervical stump, thus requiring the cervix to be excised from the uterus and retained in the body.
The second is the case of a young woman with, based on her clinical, personal and familial characteristics, a low risk for cancer, who seeks a myomectomy and wishes to preserve her fertility.
Morcellator Label Warning
The Panel was asked whether adding a “black box” warning to the label of every laparoscopic power morcellator would have merit. A black box is the most serious warning that can be placed on a drug or medical device label in the U.S. The Panel did not hesitate in its assessment: a black box was deemed appropriate and even found to be insufficient by many Panelists.
The Panel also recommended that labels should contain information to alert hospitals and physicians to cancer and other health risks inherent to the use of power morcellators. They also recommended that warnings should list the contraindications for use detailed above and mention available alternatives to morcellation.
Stringent Informed Consent to Morcellation
In addition to the black box warning, members were adamant about the imperative task of directly warning patients, as unlike with pharmaceutical drugs, patients often do not see any medical device packaging prior to its use. This inspired a proposal for the FDA to require “special controls” (a fastidious method of obtaining informed consent) from hospitals and doctors for each patient before any surgery involving — even those with the remotest potential for the involvement — of the use of a power morcellator.
These special controls would include patient education about all of the medical complications that power morcellation can cause, and would require both the patient and doctor to sign the document and to initial it, line by line.
Pro-Morcellation Conflict Protested
The names of temporary panel members, members appointed to fill vacancies on a given Panel or add to the expertise of a panel, are typically announced two days before the commencement of an Advisory Committee. In full knowledge of this fact, W&L quickly researched and prepared a letter to the FDA, detailing and protesting conflicts of interest among four of the 16 members of the Obstetrics and Gynecology Devices Advisory Committee.
This research and letter may have aided in one Panelist, San Francisco gynecologist Andrew I. Brill, to drop out of the meeting.
Brill had an ongoing financial relationship with the largest power morcellator manufacturer Ethicon, a division of Johnson & Johnson. Ethicon has paid Brill a substantial amount for his services as a consultant, speaker and white paper author. The Wall Street Journal reported Dr. Brill’s consultancy income from Ethicon to amount to nearly $213,000 for 2013 alone.
The FDA stated to the Wall Street Journal that Dr. Brill’s financial disclosures were “just above the threshold established for panel members to participate in one of our meetings.”
Update 7/31/2014: Johnson & Johnson’s Ethicon subsidiary is initiating a voluntary market withdrawal of their power morcellator until further medical guidelines are established.