FDA Approves New Natrelle 410 “Gummy Bear” Breast Implant

This is a very big deal in the field of plastic surgery.  Today the FDA approved the Natrelle (Allergan) Style 410 “Gummy Bear” silicone breast implant.  This is a true “form-stable” implant, with silicone that literally feels like a gummy bear, hence the name.  Plastic surgeons have been predicting the FDA approval of these devices for over ten years, so it’s a long-awaited announcement.  From the FDA webpage:

The U.S. Food and Drug Administration today approved the Natrelle 410 Highly
Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase
breast size (augmentation) in women at least 22 years old and to rebuild breast
tissue (reconstruction) in women of any age. Natrelle 410 implants are
manufactured by Allergan, Inc.

The FDA based its approval on seven years of data from 941 women. Most
complications and outcomes reflect those found in previous breast implant
studies including tightening of the area around the implant (capsular
contracture), re-operation, implant removal, an uneven appearance (asymmetry),
and infection.  In addition, investigators observed fissures (cracks) in the gel
of some Natrelle 410 implants.  This is a characteristic called gel fracture and
is unique to this implant.

“It’s important to remember that breast implants are not lifetime devices.
Women should fully understand the risks associated with breast implants before
considering augmentation or reconstruction surgery, and they should recognize
that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of
the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and
effectiveness,” said Shuren. “We will be looking at the results from
post-approval studies that will focus on their long-term safety and
effectiveness.”

The silicone gel in the Natrelle 410 implant contains more cross-linking
compared to the silicone gel used in Allergan’s previously approved Natrelle
implant. This increased cross-linking results in a silicone gel that’s firmer.
Cross-linking refers to the bonds that link one silicone chain to another. The
clinical significance of this type of silicone gel is not known.

These implants are completely different from the silicone gel implants otherwise on the market.  They are much firmer and hold their shape, unlike the current silicone implants in use.  Time will tell just how popular these implants will get.  Some things to consider with the Natrelle Style 410 silicone gel implant:

1. The textured surface and teardrop shape mean that these implants are made to stay in place.  Unlike the smooth-walled silicone implants currently used by most plastic surgeons, these implants are not made to move.  For some, the fact that these implants stay in their position might be construed as looking and feeling less natural.

2. They are FIRM.

3. The incision necessary to insert these implants is much longer than a traditional incision, since these implants can not be squeezed into a smaller opening.

4. The plastic surgeon who inserts these implants must be very accurate in the creation of the breast pocket.  You DO NOT want some careless doctor ripping open a breast pocket and trying to stuff one of these in you.   Make sure to see a reputable plastic surgeon who’s a member of the American Society of Plastic Surgeons and/or the American Society for Aesthetic Plastic Surgery.

5. The gummy bear implants can’t be inserted through the belly button or the armpit.  They are too stiff.

6. These implants can be useful in reconstruction, revision breast surgery, and in people with really thin tissues and a risk of bottoming out.

To read the FDA announcement about the Natrelle Style 410 “Gummy Bear” Implant approval, click HERE.

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Posted in: Plastic Surgery News

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