The Interesting History of Silicone Breast Implants

Silicone breast implants have gone the distance in restoring confidence for patients opting for both aesthetic and reconstructive procedures.

Yet given how commonplace implants are in modern plastic surgery breast augmentation and reconstruction procedures, you may have never considered the history of silicone breast implants.

There was a time in the not-too-distant past when breast implants didn’t exist at all.

The Years Before Breast Implants

Women who wanted to increase their breast size in 1889 were limited to paraffin and vaseline injections for breast augmentation. While breasts became larger, they were also hard. And patients experienced severe inflammation and disfiguration.

In 1895, a surgeon who had removed a breast tumor grafted a benign fatty tumor from the patient’s back to essentially reconstruct the breast. While this worked to some degree, it was still less than ideal.

Surgeons continued to experiment with various implant materials through the early to mid-20th century. These included wool, ground rubber, ivory, glass balls, polyethylene chips, polyether foam sponge, and teflon-silicone prostheses. They also began to experiment with different surgical methods to increase the volume of the breast, such as a rotational flap.

It wasn’t until the 1950s that silicone was first injected into the breast. The results were positive initially. But eventually, the formation of silicone granulomas caused the breasts to harden. In some cases, it was severe enough to warrant a mastectomy.

Silicone would, however, be a game changer.

The History of Breast Implants Began With Silicone

By the early 1960s, surgeons worked in tandem with laboratories to encapsulate silicone to make it safer. In 1962, the first augmentation mammoplasty was performed using a silicone implant.

While these implants were a huge improvement over the early days of injecting foreign materials, they were not without their problems. And in 1976, the U.S. Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act to classify them as moderate risk (Class II) devices and were required to comply with general controls and performance standards.

By the 1980s, there were concerns about associations between breast implants, particularly silicone-filled, and serious health issues. As such the FDA reclassified breast implants into Class III higher-risk products that required premarket approval. Manufacturers needed to provide data demonstrating the devices were safe.

1992 was the turning point year for implants. It was in this year that the FDA decided that breast implant manufacturers did not adequately address public concerns about certain complications. Rather than selecting the devices with a poor record, they removed all silicone gel-filled breast implants from the market.

Silicone implants during this time could not be used for elective surgery – though they were still available for breast reconstruction after mastectomy, replacement of existing implants, and correction of congenital deformities.

The formation of the Breast Implant Adjust Studies was developed to begin to gather data.

The Next Generation of Breast Implants

Throughout the 1990s, women seeking breast augmentation for cosmetic purposes were offered saline-filled implants.

Meanwhile, studies continued on silicone implants. And so did the implants’ evolution. By the mid to late1990s, the development of textured, anatomic, and highly cohesive silicone implants were ready for submission for FDA studies in the United States. In 1999, a comprehensive report of those studies was released that concluded there was no evidence that silicone breast implants caused systemic health problems.

It wouldn’t be until 2006, after a clinical study that followed hundreds of women with silicone implants, that the FDA would finally determine them as safe and effective – allowing women to make informed decisions about their use based on known risks and benefits. In 2011, the FDA released an update on silicone implants’ safety and found no apparent association between them and reproductive problems, breast cancer, or connective tissue disease.

Finally, in 2012, the FDA approved the first high-strength silicone implant, Known as the gummy bear, this implant is a soft yet solid gel filler with a remarkably low failure rate. Approved in Europe two decades before the U.S., These form-stable fillers allow the manufacturer to create implants that are shaped for a far more natural appearance.

What’s next in the world of breast implants? Stay tuned.

Insist on a Board-Certified Plastic Surgeon

Now that you know the history of breast implants, you may be feeling a lot more secure in your decision to have a breast augmentation procedure.

And why not? You deserve the confidence that comes with feeling good about your appearance.

So if you’re ready to speak with a board-certified plastic surgeon, contact us today. With these highly cohesive, textured, and shaped implants, you and your surgeon will have a wide selection of options in choosing the best one for you.