History of Silicone Breast Implant Regulation (Part 2)

History of Silicone Breast Implant Regulation (Part 2)

Most board certified breast surgeons, like Detroit’s Dr. Ali, now prefer silicone breast implants for their patients because of their natural look and feel, and excellent safety record.

In this two part article Troy, MI area breast implant surgeon Dr. Ali discusses the regulations that have affected silicone breast implants over the years – ensuring patient safety.

CLICK HERE for Part 1 of The History of Silicone Breast Implant Regulation

Silicone Breast Implant Regulation: 1990s

In 1992, the FDA still had concerns that the breast implant manufacturers were not adequately addressing public concerns about certain complications. At that time a higher incidence of implant rupture and silicone leakage was being seen.

So, the FDA removed all silicone breast implants from sale in the US, and required all manufacturers to submit premarket approval applications that contained detailed data on safety and effectiveness.

However, in the meantime, the FDA did allow manufacturers to provide silicone breast implants for reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants. So, the manufacturers enrolled women who received silicone breast implants for medical (not cosmetic) purposes in performance and safety studies.

Then in 1999, the Institute of Medicine (IOM) released a detailed report compiling the results of all of these published and ongoing studies on breast implants, called Safety of Silicone Breast Implants.

This report concluded that there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease. And while it did identify rare local complications (which included rupture, pain, capsular contracture, disfigurement, infection, and repeat surgeries) silicone breast implants were now recognized as generally safe.

Silicone Breast Implant Regulation: 2000s

After years of studies and technological improvements, the FDA approved silicone gel-filled breast implants in November 2006.

As with any surgery, there is always a small number of possible local complications and adverse outcomes. However, the FDA concluded that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use.

Initially, in 2006, the FDA only approved Mentor’s MemoryGel Silicone Gel-Filled Breast Implants and Allergan’s∗ Natrelle Silicone Gel-Filled Breast Implants – followed six years later by Sientra’s Silicone Gel Breast Implants.

Silicone Breast Implant Regulation: 2010s

Advanced technologies in breast implant look, feel and safety continued to be developed. And in 2013 Mentor’s MemoryShape and Allergan Natrelle 410 Highly Cohesive Breast Implants were approved.

Today these five breast implants remain the only 5 breast implants that are FDA approved for use in the US.

Troy, MI Area’s Top Breast Implant Surgeon

Dr. Ali is a Troy area double board certified Birmingham breast implant surgeon who has performed breast augmentation surgery on thousands of women in the metro Detroit area, including Birmingham, Troy, Rochester Hills, West Bloomfield, and across Oakland County. He utilizes the latest techniques and best, state-of-the-art breast implant technologies and procedures – to ensure that your results are as safe as they are beautiful. Doctor Ali will be happy to offer you a free consultation to answer all of your questions at his Birmingham office.

Feel beautiful inside and out, with breast implant surgery. And remember, financing options are also available.

Free Troy, MI Area Breast Implant Surgeon Consultation: 248-335-7200