Breast augmentation has been performed for years, although not always with the approval of the FDA. What follows in this article is information about the approval process associated with this procedure.
Many women have had breast augmentation over the years,
but not always with the approval of the FDA. The FDA is a United States agency which oversees the safety of foods, medicines and medical devices. The initials by which it’s commonly referred by stand for Food and Drug Administration. All foods, beverages, prescription medications and devices used in the medical world must now receive the stamp of approval from this agency in order to be legally allowed on the public market. This regulation wasn’t always in effect, however, and the original breast implants were being used before the rule became enforceable. Many devices manufactured in an earlier time period were allowed to be used by consumers as they were considered “grandfathered.” When something is considered to be grandfathered, it means that it existed before a ruling was made, and is therefore still allowable.
In the late 1980’s, implants filled with silicone were pulled from the market in order to be studied. At that time, there were rumors and accusations of health complications being attributed to the devices. The Food and Drug Administration decided to retract the “grandfather clause” status of implants and research them before again giving the green light to the public. Saline filled implants for breast augmentation were still allowed on the market back then, however, as they were deemed safe. Saline is similar to the salty water fluid found naturally in a human’s body.
After years of research and clinical trials, silicone implants were found safe and were released again with a stamp of approval. There are regulations, however, which must be upheld. Here’s some information about the current state of approval for these medical devices:
- Saline filled products are legally allowable for cosmetic purposes in women aged 18 and over.
- Silicone filled products are legally allowable for cosmetic purposes in women aged 22 and over.
- Age restrictions were placed on these devices as the watchdog agency decided that women younger than 18 and 22 were not mature enough to make informed and wise decisions that may impact them for life.
- The companies, Mentor and Allergan, are the only two manufacturers which are approved to produce these devices.
- These implants only received the okay from the Food and Drug Administration in the years 2000 for saline and 2006 for silicone.
- Gummy bear types, which are a different, thicker consistency of silicone considered to be safer in case of rupture, are currently being researched for usability.
- Clinical case studies are on-going for all of these products in order to gauge their long term safety and usability.
Although the research has pointed to safe outcomes, as with all medical procedures and devices, there is always risk of complication. Some of the risks for breast augmentation include scarring capsules, rupture, infection, loss of sensitivity in the nipple, inability to breastfeed a baby and asymmetry. If a woman is interested in having this procedure performed, she should make an appointment with a board certified plastic surgeon to discuss the options.
