Background Issues: 

Breast implants have been commercially available since the late-fifties. Several different types have been made. Some were semi-solid sponges, some contained silicone oil and gel mixtures and others had water-bearing filling substances. Most had thin enclosing membranes. From the outset, all types of breast implants have been surrounded with problems and morbidity. 

The sponges were abandoned in the early-seventies following endemic failures and complications. In April 1992, following a large number of adverse reactions, the widely used silicone gel filled implants were largely abandoned under pressure from U.S. regulatory agencies. Saline inflatable breast implants evolved in parallel with the sponges and the silicone gel filled breast implants. They nearly disappeared in the early-eighties following litigation by dissatisfied users and surgeons and were considered curiosities by much of the health care community. Saline inflatable implants are now the sole surviving type of breast implant except for a small number of silicone gel-based implants manufactured for specialized applications. 

The use of saline inflatable implants has been rising steadily since 1990. Widespread promotion since 1997 has contributed to a dramatic increase in users. In the U.S., for the year 1998, 132,378 new users were reported, nearly matching about 150,000 liposuction procedures, the most widely performed cosmetic surgery procedure. For the year 2000, it is projected that there will be 1 inflatable saline breast implant user for every 100 women. Considering the brief service life of saline implants and the attendant removals and replacements, it is probable that this number will be an equilibrium population of women who continuously undergo surgery at intervals of about 5-7 years to replace problem-riddled saline inflatable prostheses. 

What is a Saline Inflatable Breast Implant? 

Saline inflatable breast implants are thin bags of elastic material fitted with a filling valve. They are filled with water-containing substances. The fluid may be instilled immediately before surgery while the device is outside the body or inside the body during surgery. Some are sold pre-filled. Most are filled with water and sodium chloride. Others contain additional substances such as emulsified vegetable oils, artificial gums and water soluble resins which reduce the fluidity of the filling charge to simulate the behavior of breast tissue.  

Acknowledging Failure and Morbidity: 

Controversy and morbidity has surrounded breast implants from the outset reaching a crescendo in the late-eighties with widespread criticism of government and professional societies. Saline implants are central to the ongoing controversy. On March 1-3, 2000, in compliance with U.S. Congressional directives, the U.S. Food and Drug Administration (FDA) held Hearings regarding saline inflatable breast implants. The Hearings revealed that, in FDA-supervised clinical trials on products made by the two leading saline implant manufacturers, the Mentor Corporation and the Inamed/McGhan Group, adverse reactions were reported for about 73% of post-mastectomy users within 5 years following surgery. For cosmetic users, the level was 43% with about 20% of users being compelled to undergo secondary surgery within 3 years of the initial insertion. At the Hearings, data from these corporations were made public for the first time. 

Morbidity, Ethics and The Breast Implant Trades - Recent Highlights: 

On March 9, 2000, a securities news publisher (Bloomberg), reported that Donald McGhan, outgoing chairman of Inamed Corp., agreed to a payment of U.S. $50,000 to settle the Securities and Exchange Commission's (SEC) fraud charges surrounding misrepresentation of Inamed earnings and stock irregularities. Inamed Corp. settled similar SEC charges in August 1999 by agreeing to stiffer sanctions if future violations occurred. An April 5, 2000, letter to shareholders, Medical Device Alliance Inc. (MDA) , another firm of the McGhan-Inamed group, alleged that Donald McGhan, while in control of MDA and Inamed, had further diverted about $10,000,000 of MDA money to Inamed through complex personal stock and margin loan transactions. Litigation for recovery of the funds is in progress.  

The embarrassing disclosure at the April 2000 FDA Hearings about previously withheld saline breast implant adverse reaction data from the Mentor and Inamed corporations led to a US Congressional recommendation to investigate the continuing sale of saline inflatable breast implants. The FDA was castigated for its lax regulatory and enforcement practices. An investigation launched by the House Commerce Committee was announced in major U.S. newspapers on March 19, 2000 by the Honorable Thomas Bliley, Congressman for Virginia, currently Republican Chairman of the House Commerce Committee. 

Also on March 19th, the FDA confirmed an ongoing criminal investigation of the Mentor Corporation by its Office of Criminal Investigation. Allegations of negligence, misrepresentation and research irregularities were cited. This was published in USA Today.  

On March 23, 2000, Mentor, in USA Today, publicly denied the investigation. However, on June 28, 2000, they conceded that the FDA was indeed conducting an investigation surrounding problems with Mentor's manufacturing facility in Irving, Texas. These announcements led to drastic fluctuation of Mentor stock, triggering a secondary investigation on April 4, 2000 by the SEC at the request of the House Commerce Committee. Incidental to investigations regarding the relationship between the Mentor Corporation and Inamed, it was noted that both firms use the same implant sub-components manufactured by an Inamed subsidiary for their saline implants and that the production facilities originally owned by Mentor in Santa Barbara, California were currently occupied by Inamed. MDA leases its facilities from Inamed. 

Over the years, various manufacturers of saline inflatable breast implants, including Mentor and Inamed, have sold such implants in North America under the premise that substantially similar devices were in commerce prior to 1976 when regulations pertinent to breast implants were formally introduced. Thus, saline inflatable breast implants were deemed to have been 'grandfathered' and eligible for continuing sale without specific FDA review or approval. Several smaller manufacturers, including the PIP Corporation, NovaMed, LipoMatrix, Silimed, and Sebbin, have also distributed saline inflatable breast implants. 

During the March FDA Hearings, the PIP Corporation, a North American subsidiary of a French manufacturer, presented performance data on its product. It was the only secondary manufacturer to present at the Hearings. The FDA panel judged PIP's products and the clinical data to be without credibility and thus unapprovable.  

Problems were not limited to the U.S. On May 8, 2000, the FDA issued a Warning Letter to Biosil Limited of Glasgow, Scotland with reference to Biosil's production facility. Numerous infractions were cited including major process documentation anomalies, production defects which compromised shell security, sterility controls and inconsistencies in record keeping. This inspection followed an earlier FDA inspection resulting in a similar Warning Letter issued on December 4, 1996. The problems uncovered in 1996 had remained unresolved. Biosil is a manufacturer of cosmetic surgery products including saline implants. Its production is primarily marketed through Nagor Ltd, registered in the Isle of Man, the principal supplier of breast implants for the British Isles. Nagor is a successor to Cox Uphoff Europe. Nagor-distributed products are encountered in North America and concerns by the FDA regarding the entry of Nagor/Biosil's products into U.S. commerce motivated the inspections. This was the latest of a series of inspections of breast implant production facilities which exposed major safety and reliability problems of the product. 

On May 10, 2000, the FDA announced that saline inflatable implants were "approvable". FDA press releases emphasized the risks of saline implants but conceded that it was up to the user to made the decision as to whether or not to undergo implantation of saline breast implants in the light of short and long term complications. The FDA guidelines nevertheless forbade implantation of women under 18 and reiterated a long list of severe complications adding "that breast implants do not last a lifetime". The new FDA policy elicited strong response from many women's groups including the National Women's Health Network and the National Center for Policy Research for Women and Families who contended that salines were "not a safe product" and that "This decision really sets the FDA standard of safety at a new low".  

In June 2000, the FDA website was updated and began to post special material on breast implants emphasizing spectacular adverse effects. This included photographs of disfigured saline implant users graphically showing deformity, scarring and ulceration. The website attracted immediate censure from the breast implant trades. 

In September 2000, the FDA issued a new brochure on breast implants, emphasizing risks of disfigurement and serious infection, as well as the inevitability of continued medical treatments and repeat surgery. The brochure highlighted that implants permanently and irreversibly alter the breast, even if the implants are subsequently removed, and drastically diminish the reliability of cancer detection procedures. Finally, it interjected that women with implants may find that their "health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied". Such a brochure is unprecedented in the history of any regulatory agency worldwide. 

The Trilucent™ Soya-Filled 'Saline' Inflatable - The Most Recent Failure Amongst Many: 

The Trilucent™ is an important historical development in the breast implant trades. It was a conventional saline inflatable breast implant incorporating a valve and filled with a mixture of soya bean oil, detergent and water, as opposed to simple physiologic saline. The concept is old with roots in the late-seventies but was only formalized in the nineties in a patent credited to Dr. Leroy Young of St. Louis, Missouri. Its commercialization was largely due to Dr. Terry Knapp, a San Francisco, California plastic surgeon associated with the development of injectable collagen compounds for cosmetic facial surgery, specifically Zyderm™.  

The Trilucent™ was manufactured by LipoMatrix, a division of Collagen Aesthetics of Palo Alto, California, now owned by the Inamed Corporation. In 1996, the FDA authorized LipoMatrix to conduct clinical trials. The Trilucent™ followed the silicone breast implant crisis of the early-nineties. Its introduction coincided with the FDA Moratorium on silicone gel breast implants. The Trilucent™ was presented as a 'safe' implant based on 'natural' products. It captured the public's attention and was widely promoted in professional journals and attractive brochures targeting prospective users and surgeons. Presented as a high technology innovation of great scientific merit, it became a media darling. Sales crested on media attention and aggressive promotion by surgeons. 

It is estimated that over 350 North American women received Trilucent™ implants under the FDA-sanctioned clinical trials. Outside the U.S., the product was promoted as an "approved" and well established technology. Most European countries deemed the implant suitable for unrestricted clinical use. As a result, approximately 11000 women were implanted worldwide, mostly in Europe, many receiving breast implants for the first time, others undergoing replacement of failed silicone gel implants. 

Abuses in promotion and misrepresentation of the product became widespread. Advertisements, some sponsored by U.S. and Canadian promoters, went so far as to offer 'implant vacation packages' to prospective North American users for travel to the British West Indies, Britain and Europe on the premise of lower implantation costs and fewer formalities than in North America. Many European surgeons advertised the implantation of the Trilucent™ as a 'lifetime, safe, natural' breast implant. By 1998, such advertisements could be found in nearly every European newspaper and fashion magazine. 

Undisclosed to the public, were the unfavorable past history and the rising number of adverse reaction reports surrounding the use of the Trilucent™. Much of this was predictable. The concept underlying the design of the product was controversial from the start in view of known effects from injected oils. Necrosis of tissue and secondary calcification are documented as sequelae of such oil injections, including soy bean and other vegetable oils. Basic toxicological considerations about oxidation products from soya oil were other concerns. Epoxidized soya oils had been used as industrial plasticizers in certain classes of plastics which later emerged as toxic when left in prolonged contact with tissue. This information was either disregarded or not known to developers of the Trilucent™. Problems with the product emerged early and took the form of disaggregation and debonding of the shell because of the damaging effects of soya oil on shell materials. More serious toxicological problems followed. 

On March 9, 1999, the Medical Devices Agency (MDA) of the United Kingdom announced the withdrawal of the Trilucent™ implant as a precautionary measure following a large number of reported ruptures and adverse reactions.  

In July 1997, the FDA withdrew authorization for U.S. clinical trials of the Trilucent™. On November 9, 1998, Collagen Aesthetics announced the divestiture of LipoMatrix. Collagen Aesthetics remains a large manufacturer of cosmetic surgery products, the most widely known being Zyderm™ and Zyplast™ injections for cosmetic facial procedures. The Inamed Corporation later 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 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 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. Mentor had a similar inspection with the same outcome. In 1998, Mentor was compelled to sign a Consent Decree agreeing to bring its manufacturing practices into compliance with FDA's directives following a Texas court ruling. One class of its saline implants was subsequently withdrawn from commerce following a recall of approximately 10,000 prostheses. No information was made public about the product withdrawals or the recall. There is yet no information on compensation for users of any of the withdrawn products.  

On May 20, 1999, "Business Wire" announced an agreement between Inamed and NovaMed, a previously-independent breast implant manufacturer, granting exclusive marketing rights for NovaMed saline inflatables. This included the product NovaGold™, a variation on the saline inflatable filled with an aqueous solution of polyvinylpyrrolidinone (PVP). Inamed was to pay $8 million U.S. to NovaMed for the purchase and provide regulatory expertise and funding to obtain FDA approval for the NovaGold™ line. NovaMed is well known in biomedical circles. It was originally a corporation which manufactured products on behalf of the Vitek Corporation.  

Vitek reached global prominence in the mid-eighties when adverse reactions from its Proplast™ temporomandibular joint implants (TMJ) became the object of worldwide litigation. Injured users of Vitek products filed actions against Vitek and its subsidiaries, one of which was NovaMed. Large class actions followed, including one filed in Canada in the Ontario Superior Court of Justice (99 CV 181819). Subsequent to the bankruptcy of Vitek, residual stock of TMJ implants reappeared in Europe and Canada. The present NovaMed corporation is an offspring of Vitek. It acquired technology and supplies from and an earlier manufacturer of saline breast implants, Bioplasty Incorporated. From about 1987-1991, Bioplasty distributed breast implants in the U.S. and abroad. It was cited for infraction of FDA regulations resulting in seizure of its breast implants, known as Bioplasty Misti Gold™. The present NovaGold™ breast implant is substantially the old Bioplasty Misti Gold™ breast implant. 

Incidental to a study of breast implant adverse reactions from the LipoMatrix soya bean implant (Trilucent™), performed on behalf of a European user, it was discovered that shells for the Trilucent™ were actually surplus shells from the old Bioplasty product lines. The primary difference is that whereas the original shells were manufactured for filling with either saline aqueous solutions or PVP solutions, the one sold by LipoMatrix was filled with an emulsion of soya oil. It was discovered that the shell material was subject to partial dissolution by components of the filling material leading to failure from separation of its components.  

On December 18, 2000, the Dow Jones Newswires reported the formal recall of NovaMed's NovaGold™ PVP-filled breast implants following a protracted dispute with the U.K. Medical Device Agency (MDA). The recall was ordered on or about December 11, 2000 with the release of an Alert Letter by the MDA followed by suspension of shipments of NovaMed products from Germany to the U.K. The recall was evidently initiated following NovaMed's inability to document safety and efficacy of its products to the satisfaction of the MDA in spite of about 200 patients having been implanted in the U.K. and several thousand implanted in North America prior to 1992. NovaMed's U.S. office said they would submit clinical trial applications to the FDA. 

On December 22, 2000, the Dow Jones Newswires announced the resignation of NovaMed's directors with the exception of the president. The information was formally announced in a Securities and Exchange Commission filing. 

These revelations raise doubts about the competence of the manufacturers of the Trilucent™ and the NovaGold™. They also raise many issues regarding the forthrightness of financial transactions surrounding these corporations. The events are not surprising and support the view that most organizations who made, promoted and distributed breast implants, were staffed primarily by individuals with marginal technical skills, minimal scientific knowledge and who were guided by questionable ethical principles. 

Epilogue: 

The events of the last 15 years give credence to views widely held by many in the biomedical field that the current corporations engaged in the breast implant trades are the same entities who, from the early-seventies, have released countless untested, high risk products into commerce. Their actions and omissions have culminated in much morbidity with enormous health care costs that overshadow any potential commercial benefit that could ever accrue. These events further demonstrate that the breast implant trades have used unethical processes and deception to maintain their products in commerce and have suppressed knowledge of adverse effects from their products. These corporations have been implicated in endless adverse events and have enticed a large number of women, including many of fertile age, along a path which places their well being, their careers and their offspring at risk.  

In summary, users can expect saline inflatable breast implants to have a short service life, to impart severe discomfort, to induce repeated disfiguring surgery and eventually elicit serious adverse consequences that will demand extensive health care disbursements, in particular from third party health insurers. Of special concern, is the widespread promotion of saline inflatable breast prostheses on the basis that they constitute only a small probability of adverse effects as opposed to a certainty of failure and the continuing misrepresentation that such products present a minimal risk as they contain only "water" and 'natural' products.