Johnson
& Johnson's subsidiary and pelvic mesh manufacturer, Ethicon, Inc., informed the FDA yesterday that it is recalling four of its Pelvic Floor
Repair Systems and is asking for 120 days to “cease commercialization”
of its products, notify customers and allow physicians and hospitals
time to choose different treatments for patients. Ethicon
plans to discontinue or change its marketing materials as needed and
revise product labeling limiting the use of certain products to
abdominal procedures.
Here is the letter from the company's reps:
Ethicon has advised FDA that it will stop commercializing the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™ Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and
GYNECARE PROLIFT+M™ Pelvic Floor Repair System in the United States.
Ethicon has no present intention to commercialize these products in the future, but it has
requested that FDA allow it 120 days to cease commercialization. This time period would
permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient
time to select alternative treatment options for their patients. Ethicon will also discontinue or
revise, as appropriate, all marketing materials during this time.
Ethicon will continue to report
adverse events and provide medical communications for these products, consistent with
applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and
Biometrics place the existing 522 orders requiring additional studies for these products on hold.
Ethicon is awaiting written confirmation of that plan.
Ethicon also plans to update the product labeling for GYNECARE GYNEMESH® PS,
including the Indication for Use, to restrict the indication for use to the abdominal
sacrocolpopexy procedure for the treatment of pelvic organ prolapse. In order to allow
customers continued access to this product for patient treatment, Ethicon has requested that it be
allowed to continue the sale of GYNECARE GYNEMESH® PS using the current Instructions
for Use until FDA responds to this proposed plan.
See also:
http://www.reuters.com/article/2012/06/05/us-jj-mesh-idUSBRE85410Q20120605
