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O U T P AT I E N T S U R G E R Y M A G A Z I N E O N L I N E | J U N E 2 0 1 4
G Y N E C O L O G Y
A sampling of the reaction to the FDA advisory recommending that sur-
geons either discontinue or severely restrict the use of morcellators for
hysterectomies:
• Some hospitals have limited morcellation to a narrow range of cases
and only with a bag.
• More and more hospitals now mandate disclosing the cancer risk. The
American College of Obstetricians and Gynecologists last month issued
a statement (
tinyurl.com/me584vu
) defending morcellation for many
patients, while acknowledging the risk that it could spread cancer. The
risk, it said, should always be disclosed, but, it said, the procedure
spares women more invasive surgery.
• Saying that the company had received many inquiries from hospitals
and doctors, a spokesperson for ProAssurance Corp., a liability insurer,
told the Wall Street Journal that it was stressing the need for informed-
consent discussions with patients, including making sure patients knew
about the FDA advisory.
• Johnson & Johnson, the largest morcellator maker, has suspended
global sales, but continues to stand by the product's safety and effec-
tiveness. Intuitive Surgical cited concerns about the advisory when it
cut its growth projections for the da Vinci surgical system. The robot is
often used for the initial incisions in minimally invasive hysterectomies.
• Another company, Boston Scientific, sees opportunity in the controver-
sy. It has bought IoGyn, Inc., a pre-commercial stage company that
makes the Symphion system, which is described an alternative to the
power morcellation techniques targeted by the FDA. The system
resects the growth within the uterus and removes the tissue through its
recirculating and filtering fluid management system.
— Jim Burger
WEIGHING IN
Groups Respond to FDA Advisory
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