Updated Status on 4/01/99;  

Summary/Abstract: 

LipoMatrix of Neuchatel Switzerland, maker of the Trilucent™ breast implant with a lipid-detergent filler preparation based on soybean oil, may be bankrupt or nearly so. The corporation was was a venture firm associated with Collagen Corporation of Palo Alto, California and other California-based investor groups. The firm was capitalized in 1992 at about 8.6 $M. Its chief executive officer and main shareholder was Dr. Terry Knapp, a former San Francisco plastic surgeon. 

Approximately 11000 users, world wide, are believed to have received such devices since 1995. Unconfirmed reports of problems from Maryland and California had been circulating in US plastic surgery circles since about June 1997. Formal public acknowledgement of the U.K. ban came from a Press Release of the British Medical Device Agency (MDA) reporting adverse reactions. The advisory note is dated March 8, 1999, International Women's Day  

About 250-300 Trilucent™ implant sets are believed to have been inserted in the US and Canada as part of government sanctioned clinical trials before the trials were stopped prior completion in July 1997 . More may have been inserted in US and Canadian residents who enrolled in cosmetic surgery vacation plans promoted by Surgical Advisory Services Inc. of Aventura, Florida and where surgical implantations were to have been conducted in UK or in the Bahamas as part of the $8000 USD tour package.  

The UK Advisory follows public disclosure of seventy four adverse reaction reports by the United Kingdom health authorities. Approximately 6000 users are believed to have received such devices in UK since 1995. Principal concern include early ruptures, swelling and necrotic effects on breast tissue. Calcification of breast tissue mimicking malignant tumors following release of the filler is a current subject of interest.

Rapid shell material deterioration had been predicted following uptake of oils by the shell, leakage of the filling substances with infiltration into fatty tissue, microbiological activity within the extravasated oil/water/tissue mixtures, breast swelling as well as inflammatory response to additives and degradation by-products. 

In the US and Canada, government sanctioned clinical trials of the Trilucent™ had been interrupted in July 1997 before completion following unconfirmed reports of problems in US users. Formal public disclosure of the ban in UK came in a Press Release from the British Medical Device Agency (MDA) dated March 8, 1999, International Women's Day. The ban was extended to Denmark by the Danish Ministry of Health on March 9, 1999, the US FDA issued a Press Release on March 15, 1999 advising follow up of individuals who participated in US-based clinical trials. The Canadian health authorities released a Dear Doctor Letter with a similar recommendation on March 25, 1999. Australia and several other European countries are expected to issue similar directives. 

Product Highlights 

General Claims:

Promotional material on the Trilucent™ emphasize that X-ray tumor detection is feasible with the implants in situ and that the product presents no health risk from the filling material. The soya bean oil-based filler is described as a harmless substance with a long history of usage in food and and pharmaceutical preparations. The substance is claimed to be stable and unable to support growth of microorganisms. Each implant is stated to contain an ‘identity chip’ similar to electronic anti-theft tags which can be decoded by a remote instrument to confirm fabrication characteristics, serial and lot numbers. The shell is reported to consists of a special silicone-based material and incorporates a filling valve which is accessible to the surgeon for volume adjustment.  

Actual Structure: 

The device is basically a conventional ‘saline-inflatable’ mammary implant similar to products sold since the mid-sixties. The shell is cast from commercial silicone elastomer material using a process which has been in use since the late sixties. The filling substance is a proprietary emulsion of soya-bean derived oils (mixed triglycerides), non-ionic detergents, electrolytes and water. The viscosity characteristics approximate those of a thick oil. Significant changes in emulsion properties are noted after about a year at room temperature. Such mixtures support bacterial and fungal growth. 

The valve configuration is based on patents from the mid seventies and seal security is not demonstrated. Similar valves used on other styles of implant have been noted to leak and allow ingress of body fluid into the filling charge.  

Identification "Chip": 

This accessory depends on proprietary technology and is of minimal value for product identification. It is primarily a promotional novelty. The presence of such a chip within the item enhances the risk shell rupture and of adverse reaction to the materials used for the chip and its enclosure. The functionality of the chip in the biological environment is not demonstrated. 

Intraoperative Volume Adjustment: 

The safe filling range for an elastomer implant shell is comparatively narrow and is closely related to the mold characteristics. For practical purposes, its is nearly fixed. Underfilling leads to involution and pleating of the shell wall followed by early crease-fold failure from material fatigue. Accessing the valve intraoperatively increases to risk of bacterial contamination of the charge. This feature is therefore unnecessary and of marginal diagnostic utility.  

Lubricity of the filling Medium:  

Product claims suggest that the elevated lipid content of the filling medium will act as an internal lubricant for the shell folds thus delaying rupture. Shell failure is not caused by friction of the shell surfaces against themselves. Instead, it is caused by loss of mechanical properties of the shell over time. This problem cannot be resolved with lubricants. Thus the claim is partly false.  

Cancer Detection Feasibility: 

The claim of "radiolucency" is not supportable and illogical in the context of cancer detection. The Trilucent™ implant shell has valves parts and contains dense structures with about the same radiodensity as bone and calcific material. These parts interfere with viewing tumor-vulnerable portions of the breast. Other shell components such as patch laps also create artifacts of their own that complicate the interpretation of mammographic plates.  

Further, the implants cause degeneration of surrounding tissue with formation of mineralized material that takes the form of plate-like and spicular crystals. When dispersed in tissue surrounding the implants, these crystals of about 0.5-2.0 mm can imitate the radiographic appearance of certain classes of calcified breast malignancies. Thus the devices induce degenerative long term tissue changes that can cause false positive tumor diagnoses. In such situations, biopsies of the suspect areas are indicated and are habitually performed to rule out malignant tumors. The procedures consequently expose the users to additional concern and health risks.

TABLE 1

Status of Trilucent™ Prostheses :

Australia withdrawn yes

Austria withdrawn

Belgium withdrawn

Brazil ?

Canada clinical trial interrupted*

Denmark regulatory ban

France: withdrawn

Germany withdrawn yes

Holland withdrawn yes

Italy withdrawn

New Zealand ?

South Africa withdrawn

Sweden withdrawn

Switzerland ?

United Kingdom regulatory ban yes

United States clinical trial interrupted* yes 

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*About 250-300 Trilucent™ implant sets are believed to have been inserted in the US and Canada as part of government sanctioned clinical trials before the trials were stopped before completion in July 1997. More may have been placed in US and Canadian residents who enrolled in cosmetic surgery vacation plans promoted by Surgical Advisory Services Inc. of Aventura, Florida and where surgery would have been conducted in UK or in the Bahamas as part of a $8000 USD tour package.  

LipoMatrix' CEO and main shareholder is Dr. Terry Knapp, a former San Francisco plastic surgeon. He had been with Lipomatrix since 1992. The firm was a business venture capitalized in 1992 by the Collagen Corporation of Palo Alto California. Other shareholders included Alafi Capital of Berkeley, California, Sierra Venture Inc., Alta-Berkeley Associates, D. J. Cassin Assoc. of Menlo Park, California and A&W Co. of St. Louis, Missouri, a firm associated with Washington University. It lists Dr. Leroy Young as its principal shareholder (head of Plastic and Reconstructive Surgery at Barnes Hospital , St Louis, Missouri. Dr. Young owns the patent owner for the soybean oil implant.  

Dr. Knapp returned to the US late in the summer of 1998 and is believed to have founded Conception Technologies Inc. of Fort Collins, Colorado.  

Late Developments: 

In late 1999, Collagen Aesthetics was sold to Inamed. The Inamed Corporation, a continuation of McGhan Medical. Inamed thus acquired responsibility for the Trilucent™ and other Collagen Corporation products. 

On June 7, 2000, the British MDA recommended that all users of the Trilucent™ soya bean prosthesis be explanted. The advisory affected approximately 5000 U.K. residents and was motivated by studies which demonstrated significant cancer risks to users and infants from degradation of the soya bean filling material. 

On June 7, 2000, the New York Wall Street Journal reported that breast implant manufacturer Inamed Corp. would pay surgical removal costs of the Trilucent™ soya bean oil implant for British and U.S. users. Earlier articles in Bloomberg confirmed that Inamed borrowed $95 million U.S. to acquire Collagen Aesthetics. In November 1999, Inamed used the proceeds of an $80 million U.S. stock sale to further finance the Collagen acquisition. Inamed stock fluctuated widely during the acquisition, varying from $29 to $40 U.S. per share.

According to a June 2000 article in the Wall Street Journal, Inamed claimed it had been compelled to set aside $100 million U.S. to cover the cost of new litigation and compensation surrounding its Trilucent™ soya bean implant, the object of emerging litigation.  

Of special note, Inamed was already a major co-defendant in a U.S.-based class action for breast implants it made between 1984-1992. The class action involved more than 350,000 claimants. On February 1, 1999, the Administration Office for the U.S. Class Action (Global Settlement MDL 926), issued Order 47A announcing a "limited fund" Settlement of approximately $32 million U.S. on behalf of a sub-class of about 45,000 users, termed "INAMED" plaintiffs. Distribution of Settlement funds resulted in only a few hundred dollars per claimant. Following the Settlement, Inamed's reported sales for 1999 amounted to about $150 million U.S. with a net projected income for 1999 of about $32 million U.S.  

Since 1992, Inamed has been involved in clinical studies on its cosmetic surgery products. Its production facilities have been inspected by the FDA and citations for infractions to Good Manufacturing Practices have been issued. In the late-nineties, it withdrew several lines of saline inflatable breast implants following valve failures.