History of Silicone Breast Implant Regulation (Part 1)
History of Silicone Breast Implant Regulation (Part 1) –
Most board certified plastic 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 Detroit area breast implant surgeon Dr. Ali discusses the regulations that have affected silicone breast implants over the years – ensuring patient safety.
Silicone Breast Implant Regulation: 1960s
Gel-filled silicone breast implants were introduced to the U.S. in 1962, and in common use by 1964.
This new technology was imperfect at first. In large part this was due to lack of study or regulation on this new technology.
But thanks to advancements in technology, rigorous scientific testing, and intensive regulation by the FDA, silicone breast implants are now very safe.
Silicone Breast Implant Regulation: 1970s
Before 1976 breast implants were not highly regulated. In 1976 the U.S. Congress passed the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Under this law, breast implants were considered “Class II” (moderate risk) medical devices – and as such they had to comply with general controls and performance standards.
At that time the FDA reviewed new breast implants through a process called the 510(k) Premarket Notification process, like any other Class II products.
Silicone Breast Implant Regulation: 1980s
In the early 1980s, the FDA began to identify certain local complications and adverse outcomes of these older silicone breast implants. Some reports even described cancer and connective tissue disease in a small number of women with breast implants.
As concerns arose about the safety of silicone breast implants rose, the FDA reclassified breast implant into “Class III” (higher-risk), which requires premarket approval. Breast implant manufacturers now had to provide data demonstrating the breast implants were safe and effective BEFORE they could be sold.
CLICK HERE for Part 2 of The History of Silicone Breast Implant Regulation
Troy, MI Area’s Top Breast Implant Surgeon
Dr. Ali is a Troy area double board certified 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 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.
