Les Laboratoire Sebbin S.A. or Sebbin Labs are a French producer of silicone implants and have marketed products since about 1987. The chief executive and pricipal promoter is believed to be Gino Chitarrini. Sebbin appears to have administrative connections with other firms producing similar products in France and elsewhere. Sales and distribution centers for Sebbin products were created in North America circa 1988 and appear to be under the jurisdiction of local freelance contractors in California and Quebec Canada. 

Sebbin catalogs list items which overlap on other plastic surgery product lines from established U.S. firms. Mammary implants make up the principal Sebbin product lines. Saline inflatable, multi-lumen, gel-filled and foam-covered prostheses are comprised and sold in various styles under the tradename of LS™. Some of the items incorporate raw materials marketed through Omega Silicone. Some Sebbin products may originate from sub-contractor facilities.  

LS™ products have also been imported ad hoc into North America since about 1987. The Sebbin Corporation came to the attention of U.S. authorities in late-1989 during an investigation by the Food and Drug Administration (FDA). During the investigation, UNImed™, a Santa Barbara-based distributor, was uncovered. This organization had marketed Sebbin products for some time but had not filed a 510(k) with the FDA. The infraction led to inspection of UNImed™. The production center in Pontoise, France was later visited by U.S. Officials as part of an FDA investigation on the Corporation’s implants.  

Numerous deviations from Good Manufacturing Practices or Guidelines were noted including failure to provide raw material specifications, inadequate quality assurance, improper packing and storage, labelling as well as sterility control deficiencies. Product inserts and promotional aspects were also deemed non-compliant with FDA guidelines. It was further noted that many of their products were subject to pre-market approval and required PMA submissions prior to sale. The FDA advised recall of Sebbin products circa 1991. Subsequent correspondence advised continuing follow-up of implanted patients for possible adverse reactions. 

Several specimens of breast implants made by Sebbin have been obtained. Some had been implanted for several years. Others were new; quality has been found consistently poor. Major production defects sometime visible to the eye unaided, were frequently noted. Abnormalities such as gross production debris, uncertain sterility, incomplete curing of the shell material and major assembly defects are commonplace. Devices recovered from users following explantation for complications or device failures have been comparatively rare to date and have originated mostly from Southern California. This is surprising in view of the large number of implants imported through mail order and brought in extemporaneously by plastic surgeons attending foreign conferences. There is thus a basis for concern, in particular with regard to saline inflatable implants because of possible sterility inadequacies and inappropriate material selection leading to early device failure. 

It appears that most of the early Sebbin devices used in North America were obtained individually and directly by implanting physicians. Later users obtained implants in larger quantities through UNImed™ of Santa Barbara.

When the FDA issued the moratorium on silicone gel implant usage, the supply of implants was severely curtailed and domestic prices rose dramatically. Many clinicians sought lower priced alternatives. The attractive pricing policies of Sebbin/UNImed thus gave it a strong promotional advantage. Conference exhibition booths sometimes gave promotional implants to influential surgeons. As a result, many surgeons who attended conferences abroad rediscovered the Sebbin products and are privately importing some of these items. 

The Laboratoire Sebbin products are of marginal quality and may entail different risks from their U.S. counterparts. The use of unsanctioned medical devices subject to Class III regulations is a violation of the U.S. Medical Device Amendment. It appears surprising that a physician would implant or advise favorably about the implantation of an uncharacterized product at variance with FDA regulations. It is even more surprising that surgeons and medical product suppliers would knowingly import and distribute non-complying implants for the purpose of resale or unrestricted clinical use. 

Le Laboratoire Sebbin has had multiple addresses. Some are shown below: 

- LS. Lab _ SEBBIN, 62, rue Saint Martin - 96300, Pontoise, France (circa 1986-89) 

- LS. SEBBIN LABS, 9-11, rue Benoit Malon - 92150, Suresnes, France (circa 1987-89) 

- LS. SEBBIN LABS, 111 Oceano, Suite G, Santa Barbara, CA 93109 (circa 1988-89) 

- POLYTECH, 44 - rue Saint Isidore - 69003, Lyon, France (circa 1990-present) 

- UNIMED, P.O. Box 40626, Santa Barbara, California 93140 (circa 1989-92) 

- Omega Silicone, 725 Yanonali St., E., Santa Barbara, CA 93103 (circa 1991-94) 

- Sebbin Laboratories, 38, rue de Latour Billy, Argenteuil, France