Import Alert 89-09

(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).

Import Alert # 89-09

Published Date: 10/12/2011

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Liquid Injectable Silicon (LIS) Labeled Medical Grade Or Intended For Medical Use"

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.

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 liquid injectable silicone (LIS) labeled as medical grade or intended for medical use from any country. Known countries of origin are: Germany (DE), England (GB), Panama (PA), Taiwan (TW), Italy (IT), France (FR). 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 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 301 796-6600.

Product Description:

Liquid injectable silicone (LIS)

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

Countries

FRANCE

(79 K - - GM) Silicone, Liquid, Injectable