Criticism
In the early 1990s, the national health ministries of the listed countries reviewed the pertinent studies for causal links among silicone-gel breast implants and systemic and auto-immune diseases. The collective conclusion is that there is no evidence establishing a causal connection between the implantation of silicone breast implants and either type of disease. The affected women complained of systemic disease manifested as fungal, neurologic, and rheumatologic ailments. The Danish study Long-term Health Status of Danish Women with Silicone Breast Implants (2004) reported that women who had breast implants for an average of 19 years were no more likely to report an excessive number of rheumatic disease symptoms than would the women of the control group. The follow-up study Mortality Rates Among Augmentation Mammoplasty Patients: An Update (2006) reported a decreased standardized mortality ratio and an increased risk of lung cancer death among breast-implant patients, than among patients for other types of plastic surgery; the mortality rate differences were attributed to tobacco smoking. The study Mortality Among Canadian Women with Cosmetic Breast Implants (2006), about some 25,000 women with breast implants, reported a 43 per cent lower rate of breast cancer among them than among the general populace, and a lower-than-average risk of cancer.
| Year | Country | Systemic Review Group | Conclusions |
|---|---|---|---|
| 1991–93 | United Kingdom | Independent Expert Advisory Group (IEAG) | There was no evidence of an increased risk of connective-tissue disease in patients who had undergone silicone-gel breast implant emplacement, and no cause for changing either breast implant practice or policy in the U.K. |
| 1996 | United States | U.S. Institute of Medicine (IOM) | There was “insufficient evidence for an association of silicone gel- or saline-filled breast implants with defined connective tissue disease”. |
| 1996 | France | Agence Nationale pour le Developpement de l’Evaluation Medicale (ANDEM) | French original: “Nous n’avons pas observé de connectivite ni d’autre pathologie auto-immune susceptible d’être directement ou indirectement induite par la présence d’un implant mammaire en particulier en gel de silicone. . . .”
English translation: “We did not observe connective tissue diseases to be directly or indirectly associated with (in particular) silicone-gel breast implants. . . .” |
| 1997 | Australia | Therapeutic Devices Evaluation Committee (TDEC) | The “current, high-quality literature suggest that there is no association between breast implants and connective tissue disease-like syndromes (atypical connective tissue diseases).” |
| 1998 | Germany | Federal Institute for Medicine and Medical Products | Reported that “silicone breast implants neither cause auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast-feeding capability, or the health of children who are breast-fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease.” |
| 2000 | United States | Federal court-ordered review | “No evidence of an association between . . . silicone-gel-filled breast implants specifically, and any of the individual CTDs, all definite CTDs combined, or other auto-immune or rheumatic conditions.” |
| 2000 | European Union | European Committee on Quality Assurance & Medical Devices in Plastic Surgery (EQUAM) | “Additional medical studies have not demonstrated any association between silicone-gel filled breast implants and traditional auto-immune or connective tissue diseases, cancer, nor any other malignant disease. . . . EQUAM continues to believe that there is no scientific evidence that silicone allergy, silicone intoxication, atypical disease or a ‘new silicone disease’ exists.” |
| 2001 | United Kingdom | UK Independent Review Group (UK-IRG) | “There is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes.” |
| 2001 | United States | Court-appointed National Science Panel review | The panel evaluated established and undifferentiated connective tissue diseases (CTD), and concluded there was no causal evidence between breast implants and these CTDs. |
| 2003 | Spain | Science and Technology Options Assessment (STOA) | The STOA report to the European Parliament Petitions Committee reported that the current scientific evidence demonstrates no solid, causal evidence linking SBI to severe diseases, e.g. breast cancer, connective tissue diseases. |
| 2009 | European Union | International Committee for Quality Assurance, Medical Technologies & Devices in Plastic Surgery panel (IQUAM) | The consensus statement of the Transatlantic Innovations conference (April 2009) indicated that additional medical studies demonstrated no association between silicone gel-filled breast implants and carcinoma, or any metabolic, immune, or allergic disorder. |
Read more about this topic: Breast Implant Controversy
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