Concerns over cancer risk have divided the medical community. If you have been following healthcare media and popular press over the past 6 months, you have no doubt seen the headlines:
- Boston surgeon, physician wife campaign against procedure (Boston Globe 12/18/13)
- When a hysterectomy can be a death sentence (USA Today 02/18/14)
- Two hospitals adjust hysterectomy surgery (Boston Globe 03/28/14)
- Johnson & Johnson Suspends Sale of Device Used in Fibroid Surgery (WSJ 04/29/14)
- Doctors Group Defends Hysterectomy Technique: AAGL Discourages Morcellation on Older Women, Citing Cancer Risk, but Says Procedure Has Its Place (WSJ 05/08/14)
While we have not yet seen a mid-day commercial about morcellator litigation, there is quite a bit of online advertising by law firms for restitution from complications.
Although morcellation devices aren’t new in the medical field and their use has become commonplace, the power morcellator was only introduced about 10 years ago, so the full scope of long and short-term ancillary effects are still under investigation. Recent reports link the use of power morcellators in gynecologic surgery with the potential dissemination of malignant tissue, which may result in worsening of previously undetected cancer. Estimates for this complication are between 1 in 350 and 1 in 500 for women undergoing fibroid surgery with morcellation. While morcellation is contraindicated in women with strongly suspected or known malignancy, preoperative diagnosis of some uterine cancers can be difficult.
While this risk was previously known, it gained traction following the cancer diagnosis in Dr. Amy Reed, a Boston anesthesiologist, and another patient who had undergone surgery at Brigham & Women’s Hospital. Dr. Reed recently underwent cancer treatment; the other patient has since died.
Highlighting the gravity of this issue, last month, the FDA released a Safety Communication discouraging the use of laparoscopic power morcellation in some women during hysterectomy or myomectomy for the treatment of uterine fibroids. Johnson & Johnson, the major supplier, has also suspended sales worldwide and many providers and hospitals have discontinued or modified the use of power morcellators. Conversely, however, professional medical organizations such as the American Congress for Obstetricians and Gynecologists (ACOG), the American Association of Gynecologic Laparoscopists (AAGL), and the Society of Gynecologic Oncology (SGO) have responded with caution. While acknowledging the risk that “morcellation of an undiagnosed cancer may adversely affect a patient’s prognosis,” (ACOG, May 9), these organizations point out that minimally invasive surgery to remove uterine fibroids carries much less morbidity and mortality than major abdominal surgery.
Due to the potential for patient harm (as well as professional, financial and reputational risk to the provider and the organization), development of a sound process for power morcellator use based on scientific evidence, regulatory body directives, and guidance from professional medical organizations is essential. If morcellator use will continue, the following should be considered:
- Appropriate patient selection
- Thorough pre-operative evaluation
- Use of intraperitoneal bags and related risks
- Training and credentialing of the provider, including use of intraperitoneal bags
- Informed consent discussions (ACOG, May 9), including:
- Potential risk of undiagnosed gynecological cancers
- Increased likelihood of dissemination if an occult malignancy is present
- Possibility of seeding viable ectopic tissue if fragments of benign tissue are disseminated through morcellation
- Concerns regarding use of an intraperitoneal bag
- Alternative surgical options
- Documentation of the informed consent process
- How practices and processes will be defended if unintended consequences result (i.e., worsening of disease) occur, and a claim is made.
There is no doubt that the FDA, key medical organizations, and affected female patients all have the same common goal when it comes to gynecologic surgery involving the use of power morcellation: safe, appropriate and high-quality care. Going forward, these parties will work together to develop a safe process. On July 10th and 11th,the FDA’s Obstetrics and Gynecological Devices Panel will hold a public meeting, where members will seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures. They will make recommendations regarding the appropriate use, pre-market testing, labeling, and other risk mitigations (including the use of containment bags), and assist the FDA in determining the appropriate level of regulatory control necessary for this device type.
Until further guidance is available, it is up to medical staff leadership and hospital administration executives, along with risk management professionals, to determine each organization’s position, and whether morcellation procedures will be modified, or discontinued.
RCM&D’s risk management consultants are available to assist you in analyzing your risks and supporting your efforts in ensuring the highest level of patient safety for your organization.