Breast Augmentation and the FDA


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.

Source: Free Articles from


When looking for a doctor to perform breast augmentation, Tallahassee
residents are advised to research their options. The Tallahassee Plastic
Surgery Clinic is dedicated to providing personal and professional care
for its patients. For more information on services offered or to
schedule a consultation, please visit
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