IA #89-09, 8/13/01, DWPE OF LIQUID INJECTABLE SILICON (LIS) LABELED MEDICAL
GRADE OR INTENDED FOR MEDICAL USE"
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT : *** Detention Without Physical Examination (DWPE) ***
NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(s)
at issue. It does not create or confer any rights for or on any
person, and does not operate to bind FDA or the public.
PRODUCT: Liquid injectable silicone (LIS)
PRODUCT
CODE: 79K[][]GM
PROBLEM: Lacks premarket approval (PMA) for distribution.
PAF: AAP (Approvals)
PAC: 82008
COUNTRIES: All countries
*** Known countries of origin are: Germany (DE), England (GB),
Panama (PA), Taiwan (TW), Italy (IT), France (FR). ***
MANUFACTURER/
SHIPPER: All manufacturers
(Known shipper: Terple Enterprises S.A. which has known mail drop
off sites in the Republic of Panama and Florida)
IMPORTER'S
I.D.#: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the device appears to be a Class III
device without an approved application for premarket approval
pursuant to Section 515 of the Act, or an exemption pursuant to
Section 520(g)(1) [Adulteration, Section 501(f)(1)(C)]."
OASIS CHARGE
CODE: No PMA
RECOMMENDING
OFFICE: CDRH, Office of Compliance (HFZ-300)
REASON FOR
ALERT: To prevent further importation of a medical device that does not
have a PMA clearance for marketing.
Liquid Injectable Silicone (LIS) was first used in the 1940's to
augment soft tissues. LIS is presently used in breast
augmentation; "microinjections" of LIS are used to correct minor
facial deformities (pockmarks, wrinkles) and facial "contouring"
such as lip enlargement, and intraocular to prevent retinal
detachment, none of which have been approved by FDA. (See ***
GUIDANCE *** for LIS with IDE's for use in retinal attachment).
LIS is a Class III "transitional device" under Section 520 (1) of
the Federal Food, Drug, and Cosmetic Act (the Act). Since
designated as a medical device by FDA , LIS has only been
considered as an investigational device by FDA and is not approved
for distribution in this country for plastic surgery or other
medical uses, except within the parameters of active
Investigational Device Exemptions (IDEs). FDA has not approved a
PMA to LIS for any use. Therefore, the use of LIS in plastic
surgery, or any dermatological use, is a violation of the Act.
***
GUIDANCE: Districts may detain without physical examination all shipments of
LIS labeled as medical grade or intended for medical use. CDRH
has information to demonstrate that LIS labeled for industrial use
in some instances has been filtered and used for injection into
humans for dermatological and cosmetic purposes.
Districts may detain without physical examination all shipments of
LIS from Terple Enterprises whether it is labeled for industrial
or medical use.
Districts should evaluate all shipments of LIS labeled for
industrial use. Determine the shipper and importer for the
shipment. If either the shipper or importer is not an industrial
account but an individual, physician, or hospital, detain the
shipment. Contact CDRH/Office of Compliance/Division of
Enforcement (301) 594-4613 for further information and
verification if LIS has a current IDE for use in retinal
attachment.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology ,
contact the Division of Field Science at (301) 827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEYWORDS: Silicone, oils, gels, LIS
PREPARED
BY: Ted Poplawski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS:
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