Health Scares of Breast Implants

The two main types of filler used in breast implants are either silicone gel, which has been tighter regulated historically due to health scares, or saline.

When silicone gel filled breast implants were first marketed back in the 1960’s, they were unregulated and not considered a threat to health. Throughout the 1970’s and 1980’s challenges were made claiming silicone gel responsible for numerous detrimental side effects on health.

In 1991 the FDA mandated new regulation requiring manufacturers of silicone gel filled breast implants to submit pre-market approval applications (PMAs), presenting data supporting reasonable safety of the product for it to remain on the market.

By 1992 no PMA yet submitted provided sufficient data to grant approval of the medical product on grounds of safety. Over the next decade many women filed lawsuits blaming silicone gel filled breast implants responsible for various diseases such as connective tissue disorder, cancer, and neurological disease.

In the decade following the 1992 moratorium, the use of silicone breast implants were limited to controlled clinical trials, reconstructive surgery or for ruptured filler gel replacement. In the light of these restrictions, saline breast implants gained popularity and was the common adopted choice of implant for enlarging breasts cosmetically.

After data trials conducted on breast implant patients spanning over a decade, in 2006, the FDA lifted its restrictions on silicone gel filled breast implants for woman over the age of 22, and on the condition the manufacturer has carried out a 10 year study supporting reasonable safety of the product. There is however, as pointed out still risk of silent rupture and leakage, and so frequent MRI scanning is advisable.

In recent years a growing availability of non surgical alternative ways of enlarging breasts give women an opportunity to increase their breast size without having implants inserted.