US FDA Approved Products

The US FDA’s approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of botulinum toxins, wrinkle fillers, and fat removals when injected into specified areas of the body.

 

Most cosmetic fillers have a temporary effect, because they contain materials that are absorbed by the body over time. The FDA has approved only one product made from a material that remains in the body and is not absorbed. Some cosmetic fillers also contain lidocaine, which is intended to decrease pain or discomfort related to the injection.

 

The materials used in cosmetic fillers include the following:

Absorbable (temporary) materials

  • Collagen: Collagen is a type of protein that is a major part of skin and other tissues in the body. Sources of purified collagen used in soft tissue fillers can be from cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting of injectable filler materials.

 

  • Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage. It is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6 – 12 months.

 

  • Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. For wrinkle filling in the face or for the hand, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the back of the hand. The effects of this material last approximately 18 months. While in the body, calcium hydroxylapatite will be visible in x-rays and may obscure underlying features.

 

  • Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years.

 

Non-absorbable (permanent) materials

  • Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. When used as a soft tissue filler, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face.

 

Botulinum Toxins

 

Cosmetic Fillers

 

Fat Removal

  • Kybella (SOLD OUT – Currently, out of stock)

 

Source: Dermal Fillers Approved by the Center for Devices and Radiological Health

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USFDA Approved Products
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USFDA Approved Products
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The US FDA approval is based on the review of data collected from clinical studies that evaluated the safe and effective use of botulinum toxins & wrinkle fillers when injected into specified areas of the body. We at Rx Beauty Garden LLC would like to take this opportunity to list the US FDA approved products.
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Rx Beauty Garden LLC
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