Procedures

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Beginnings of Breast Augmentation

Cosmetic breast augmentation first began in the 1960s, prior to the 1976 law that provided medical regulatory authority to the Food and Drug Administration. This means that the implants and other medical devices used for breast augmentation had not been evaluated and approved by any independent agency prior to their use. When the FDA became responsible for ensuring the safety andeffectiveness of medical products and drugs, these breast augmentation products were allowed to remain on the market with the understanding that, at some point, the FDA would inquire into the safety and effectiveness of these medical devices.

SiliconeImplant Recall

Breast augmentation studies and research since this time have been conducted because of serious safety concerns regarding breast implants. As women began reporting numerous local complications after breast augmentation, experts and consumers began to request information by way of breast augmentation studies and research. In 1992 silicone implants were pulled from the market after serious concerns about local complications, particularly implant rupture and its adverse consequences. After this recall and the numerous reports of illness and injury from silicone implant patients, medical organizations began to conduct comprehensive breast augmentation studies and research to learn more about the safety of breast implants.

Connective Tissue Diseases

There were a number of breast augmentation studies and research focusing on the safety of silicone breast implants after the recall. The Harvard Nurses Health Study is considered the largest "look back" study of silicone implant risks. More than 87,000 nurses participated in this study, all of whom had received silicone breast implants between 1976 and 1990. Breast augmentation studies and research found no increased risk of connective tissue diseases as a result of silicone breast implants.

The 1994 Mayo Clinic study found that of the 749 subjects studied, no increase in connective tissue disorders was found among those with silicone breast implants. These breast augmentation studies and research, though helpful, were determined to be largely inadequate and inconclusive. The rate of connective tissue diseases in the general population is so low (approximately one in every 100,000) that these studies have been deemed too limited in scope to get an accurate picture of connective tissue risks in women with silicone implants.

Rupture Rates

Breast augmentation studies and research have also focused on the rupture rates for breast implants. In 1995, professional medical testimony presented to the FDA indicated that breast implant rupture rates were somewhere between five and fifty-one percent, a range too large to determine the real risk of rupture. Breast augmentation studies and research have shown that the risk of rupture increases with the age of the implant, and most patients will experience implant rupture or some other complication requiring additional medical attention within ten years of breast augmentation surgery.

Required Research

After the silicone implant recall, the FDA began requiring that implant manufactures conduct breast augmentation studies and research to discover more about the safety and efficacy of their products. These companies agreed to conduct human trials in three phases: urgent need, adjunct, and core studies. Urgent need studies were to focus on the immediate safety of implants already used. Adjunct studies were designed to produce information about the short term safety of breast implants. Core studies were aimed at producing long term safety data.

Research Gaps

Breast augmentation studies and research of this nature began around 1992. Even to date, there are gaps in breast augmentation studies and research regarding long term safety of breast implants, which the FDA hopes will be resolved in the near future. Breast augmentation studies and research have still not produced substantial information about the risk of cancer in women with breast implants. The effect of breast implants on pregnancy and breast feeding is still unclear. There are still other gaps in breast augmentation studies and research that must be filled in order to develop a clear and complete picture of breast implant risks and benefits.

Re-instating Silicone Implants

Recent breast augmentation studies and research have focused on silicone breast implants once again. Two major US implant manufacturers have been aggressively pushing for FDA approval on cohesive silicone breast implants which have been banned for 12 years. The company Mentor received conditional approval in July 2005 to begin marketing their implants, while Inamed is still working to gain FDA approval on their silicone implants.