Documentation Report By Pierre J. J. B. Blais, B. Sc., Ph.D., C. Chem., F.C.I.C.
BREAST IMPLANTS – A GROWING AREA OF CONCERN
Diana Zuckerman, Ph.D., one of the scientists credited with initiating the report to the U.S. Congress on the FDA’s Regulation of Silicone Breast Implants in 1992, said that with the FDA’s approval of saline implants in spring 2000, and I quote, “the FDA has set a new low standard”. In connection with the events of 2005-2006 and the resubmission of silicone-gel-filled implants to the FDA and Health Canada, Dr. Zuckerman again went on record on several occasions advising caution and at one point labeling Health Canada’s advisory panel on breast implants as a “sham, with an Advisory Panel that includes several paid consultants to the companies that make breast implants”. The US and Canada have now returned to basically the same point as they were in the late eighties.
Manufacturers and surgeons will earn nearly a billion a year on breast implants. This is the reason why plastic surgeons and most doctors do not talk negatively about breast implants. The devices are part of a huge taxable cash-generating machine. They are also the cause of enormous health care costs that would otherwise not be incurred.
The safe salt water in saline is not simple or safe for long. Saline has a short shelf life and no hospital will wash a scratch with outdated saline, yet women are constantly being told how safe saline is and that in breast implants it remains good indefinitely. Yet, in reality it begins to turn septic in less than two years time.
On the occasion of FDA Panel Hearings in April 2000, Dr. Pierre Blais, a former Canadian Government researcher and Senior Scientific Advisor, prepared a report to the FDA. He made 14 recommendations on the process for approval and continuing sale of saline inflatable implants. Twelve recommendations were later implemented. However, the quality of fabrication is not significantly better. The new, improved silicone-gel-filled implants of today that Health Canada-approved in 2006, and the US in 2007 are no better than those sold in the eighties. In the meantime, promotion, both direct and indirect, through “reality” television shows is greater than ever while problems are as frequent and as severe as before. Dr. Blais current writings on the matter are summarized below:
Breast implants, some remarkably absurd and dangerous, have been used in increasing numbers since the fifties. Surrounded by dubious advertising, secretive surgical techniques, and widespread adverse effects, breast implants acquired a seedy image and their use was strongly condemned by the health care community until the seventies. Two product classes of breast implants remain, both relying on a thin outer shell filled with a solution of salt water or silicone gel. They are promoted as safe and government-approved. Neither assertion is correct.
In 1992, Canada and the United States imposed a Moratorium on the sale of silicone-gel-filled breast implants, largely in response to pressure from consumer and women’s groups concerned about rising morbidity . Saline-filled breast implants essentially became the sole option.
Saline-filled implants were presented as safe and natural, containing only salt (saline) and water. However, even if this was true at implantation, it did not remain that way for long. Saline has a limited shelf life and even if ’sealed’ within a breast implant, it turns septic. Saline implants are rarely hermetically ’sealed’. They do not have secure filling valves, allowing infiltration of the user’s body fluids and stray bacteria into the implant. Within a short time, the original saline solution incubates and decaying substances build up. When shell leakage occurs, the contaminated saline is discharged into the user. These problems are well known within the cosmetic surgery industry.
By about 1997, and because of problems with saline-filled implants, cosmetic surgeons and special interest groups lobbied for the return of silicone-gel-filled implants. After a bitter public debate, Health Canada relented and the sale of silicone-gel-filled prostheses resumed in Canada on October 20, 2006. The process was termed ‘licensing’. Conditions of sale include a disclosure of risks the products pose and the need for multiple replacements over the life of the user. Regrettably, the ‘license’ is being presented by breast implant interests as government approval and a proof of safety. The U.S. FDA ended its Moratorium on November 18, 2006, creating a similar situation in the US.
The lifting of the Moratoria in Canada and the U.S. led to a return to a pre-Moratorium situation when breast implants of all kinds could be sold for any application. In 2007, incidental to litigation involving breast implants and consumer products, the Court of Appeal of Ontario and the Supreme Court of Canada made it clear that Health Canada, the agency responsible for lifting the Canadian Moratorium, was under no duty to warn Canadians of dangerous medical devices, demonstrating that any claim of safety based on Health Canada’s ‘approval’ or ‘licensing’ is without substance. In the U.S., a legal peculiarity termed FDA ‘preemption’ placed similar limitations on legal recourse available to injured users of breast implants.
Post-Moratorium silicon- gel-filled implants are fundamentally the same as pre-Moratorium versions. They are still devoid of credible science, use the same constituents and technologies, and are no better made. They are manufactured by successors of firms who repeatedly went into receivership and continue to change hands at intervals of about two years. In 2006, when the Moratorium ended in Canada and the U.S., there were three significant breast implant makers (Mentor, MediCor, and Allergan). MediCor went into receivership in 2008. Its Chief Executive Officer was indicted for embezzlement of more than $94 million relating to the acquisition of breast implant manufacturing facilities. These manufacturers made both silicone-gel-filled and saline-filled implants.
Saline implants have a curious history. Commercialized in the mid-sixties, they were problem-plagued from the outset, laborious to insert, and easily contaminated during intraoperative filling. Shells failed early, valves leaked, and users complained of poor esthetics. Frequent deflations, infections, and deformity were problems which remained unresolved. By the early eighties, salines were rarely used and manufacturers nearly discontinued the products in favour of the less costly and more easily inserted silicone-gel-filled implants. The Moratorium of 1992 was a setback for the industry. Conversely, the saline implants became its salvation. More than 500,000 such implants were sold in North America during the Moratorium. Not surprisingly, all negative aspects of these devices received minimal public exposure. Now the situation is reversed with silicone gel implants receiving praise and promotion.
Breast-implant promoters are not reliable sources of information. The breast-implant industry earns close to 1 billion dollars a year from breast implants and relies on low-cost, easily inserted implants. The silicone-gel-filled implants fulfill this requirement admirably. To much of that community, quality and safety issues are secondary.
Most new breast-implant users are young women unfamiliar or unconcerned about events of the past. Like their predecessors, they will swell the ranks of chronically-injured breast-implant users whose health and appearance will continue to deteriorate. Many will be compelled to undergo repetitive breast surgery approximately every 5-7 years to replace or remove problem-riddled prostheses. Health-care costs engendered by the churning of implant users will rise and will greatly impact on Canada’s publicly-funded health-care system, already strained to the limit for essentials. The system was not designed to encompass cosmetic surgery complications and cannot cope with the treatment of its sequelae without diverting resources urgently needed elsewhere.
Less than 5% of new users are breast-cancer patients, nearly unchanged over the last two decades. About 10% of new implants go into existing users for ‘replacement’ of earlier implants that failed and left them disfigured. This number is rising, reflecting failures and ‘wearing out’ of devices inserted during the Moratorium.
Adverse effects from breast implants are as numerous and as severe as before and continue unabated. It appears that the lessons of the past have not been learned and augmentation procedures still converge to permanent, irrecoverable chest damage.
In many ways, the plight of breast-implant users appears to have worsened. The number of implant users is increasing too fast, the number of surgeons willing and capable of repairing damaged chests from breast implant misuse is decreasing, and few general practitioners are prepared to treat the long-term health problems of implant victims. Provincial health insurance programs and private third-party health insurers are reluctant to approve surgical costs for any form of breast surgery. It is morally wrong for any government to allow breast implants on the market and then to recoup lost revenue, as is being done in the U.S.A., and at the same time agreeing with the manufacturers and plastic surgeons that they are “safe and effective”.
Breast implants “are the least effective and most problematic devices” that have “ever been approved”, says Cindy Pearsons, executive director of the consumer advocacy group of the National Woman’s Health Network of Washington D.C. “The complications continue to rise with each successive year after surgery, and implants usually have a negative impact on a woman’s health”.
Enquiries are invited,