The two methods of butt augmentation are implant placement and fat grafting. The advantage of implants is that they can be used in patients who might not have enough fat to harvest for injection. They are also permanent. However, implants also have many common side effects including chronic pain, infection, seroma formation (fluid collections around the implants), and hardening with unnatural feel. Because of these possible complications, many surgeons prefer fat injections… Read full article via  Dr John Burns :: Dallas Plastic Surgery Institute

But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

What Consumers Should Know

FDA is alerting consumers that

• it has not evaluated or approved products for use in lipodissolve
• it is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
• the safety of these substances, when used alone or in combination, is unknown
• it is not aware of clinical studies to support medical uses of lipodissolve

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include

• permanent scarring
• skin deformation
• deep, painful knots under the skin in areas where the lipodissolve treatments were injected

FDA Actions

On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products. (Cyber letters are letters sent to companies whose U.S. online sales of products may be illegal.)

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve

• are safe and effective
• have an outstanding safety record
• are superior to other fat-loss procedures, including liposuction

Additionally some of the letters indicate that the companies have made claims that lipodissolve can be used to treat certain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities.

The U.S. companies receiving warning letters in regard to lipodissolve products are

• Monarch Med Spa, King of Prussia, Pa.
• Spa 35, Boise, Idaho
• Medical Cosmetic Enhancements, Chevy Chase, Md.
• Innovative Directions in Health, Edina, Minn.
• PURE Med Spa, Boca Raton, Fla.
• All About You Med Spa, Madison, Ind.

FDA is requesting a written response from these U.S. companies within 15 business days of receipt of the letters stating how they will correct these violations and prevent similar violations in the future. These firms were told that failure to promptly correct the violations may result in legal action.

The Brazilian firm getting a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. FDA will notify regulatory authorities in Brazil of this action. The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.

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How to Report Side Effects

Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

• online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm⁴
• by regular mail: Use postage-paid, pre-addressed FDA form 3500⁵
• by Fax: (800) FDA-0178
• by phone: (800) FDA-1088

This article appears on FDA’s Consumer Updates page⁶, which features the latest on all FDA-regulated products.

What about “decal”-type temporary tattoos?

Temporary tattoos, such as those applied to the skin with a moistened wad of cotton, fade several days after application. Many contain color additives approved for cosmetic use on the skin. However, FDA has received reports of allergic reactions to some temporary tattoos.

An Import Alert is in effect for several foreign-made temporary tattoos1. According to Consumer Safety Officer Allen Halper of FDA’s Office of Cosmetics and Colors, the temporary tattoos subject to the import alert are not allowed into the United States because they don’t have the required ingredient declaration on the label or they contain colors not permitted for use in cosmetics applied to the skin.

What about henna, or mehndi?

Henna, a coloring made from a plant, is approved only for use as a hair dye, not for direct application to the skin, as in the body-decorating process known as mehndi. This unapproved use of a color additive makes these products adulterated and therefore illegal. An import alert is in effect for henna intended for use on the skin2. FDA has received reports of injuries to the skin from products marketed as henna.

Since henna typically produces a brown, orange-brown, or reddish-brown tint, other ingredients must be added to produce other colors, such as those marketed as “black henna” and “blue henna.” So-called “black henna” may contain the “coal tar” color p-phenylenediamine, also known as PPD. This ingredient may cause allergic reactions in some individuals. The only legal use of PPD in cosmetics is as a hair dye. It is not approved for direct application to the skin. Even brown shades of products marketed as henna may contain other ingredients intended to make them darker or make the stain last longer.

In addition to color additives, these skin-decorating products may contain other ingredients, such as solvents.

How do I know what’s in a temporary tattoo or henna/mehndi product?

Cosmetics including temporary skin-staining products that are sold on a retail basis to consumers must have their ingredients listed on the label. Without such an ingredient declaration, they are considered misbranded and are illegal in interstate commerce. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA).

Because the FPLA does not apply to cosmetic samples and products used exclusively by professionals–for example, for application at a salon, or a booth at a fair or boardwalk–the requirement for an ingredient declaration does not apply to these products.

Does FDA approve color additives?

By law, except for coal tar colors used in hair dyes, color additives3 used in cosmetics must be approved by FDA for their intended uses. Some may not be used unless FDA has certified in its own labs that the composition of each batch meets the regulatory requirements. Cosmetics–including temporary tattoo products–that do not comply with restrictions on color additives are considered adulterated and are illegal in interstate commerce.

Does FDA approve other cosmetic ingredients?

Except for color additives, FDA does not have the authority to approve cosmetic products or ingredients, although the use of several substances in cosmetics is prohibited or restricted4 due to safety concerns. However, if the safety of the product or its ingredients has not been substantiated, the product is misbranded–and therefore illegal in interstate commerce–if it does not have this warning on the label:

“Warning-The safety of this product has not been determined.”

via Temporary Tattoos & Henna/Mehndi.

What are “sunless tanners”?

Neither the laws nor the regulations enforced by FDA define the term “sunless tanner.” It typically refers to products that provide a tanned appearance without exposure to the sun or other sources of ultraviolet radiation. One commonly used ingredient in these products is dihydroxyacetone (DHA), a color additive that darkens the skin by reacting with amino acids in the skin’s surface.

What are “bronzers”?

Like the term “sunless tanner,” “bronzer” is not defined in either the laws or the regulations enforced by FDA. It is often used to describe a variety of products intended to achieve a temporary tanned appearance. For example, among the products marketed as bronzers are tinted moisturizers and brush-on powders. These produce a temporary effect, similar to other types of makeup, and wash off over time. Some products are marketed with other ingredients in addition to DHA in order to provide a tanned appearance.

What does the law say about color additives, and DHA in particular?

The Federal Food, Drug, and Cosmetic Act¹ (FD&C Act), Section 721 authorizes the regulation of color additives (other than coal-tar hair dyes), including their uses and restrictions. These regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70². If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. Such misuse of color additives causes a cosmetic to be adulterated.

DHA is listed in the regulations as a color additive for use in imparting color to the human body. However, its use in cosmetics–including sunless “tanning” products–is restricted to external application (21 CFR 73.2150). According to the CFR, “externally applied” cosmetics are those “applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane” (21 CFR 70.3v). The industry has not provided safety data to FDA in order for the agency to consider approving it for use on these exposure routes, including “misting” from tanning booths.

In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use (21 CFR 70.5a) DHA is not permitted for use in the area of the eye. The CFR defines “area of the eye” as follows:

“the area enclosed within the circumference of the supra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge.” (21 CFR 70.3s)

As with the lips and other areas covered by mucous membrane, the industry has not provided safety data to FDA in order for the agency to consider approving it for use in the area of the eye.

The regulations listing DHA as a color additive also require it to meet tight specifications, with strict limitations on impurities. For example, volatile matter must not exceed 0.5 percent when measured at 34.6 degrees centigrade for three hours at a pressure of not more than 30 mm. mercury. (Please note that the reference to “millimeters of mercury” is a measure of atmospheric pressure, not an indication that DHA contains mercury.) Certain minerals are restricted to miniscule amounts, measured in parts per million (21 CFR 73.1150 and 73.2150).

What does this mean for DHA spray “tanning” booths?

As noted above, the use of DHA in “tanning” booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the Agency for review and evaluation, When using DHA-containing products as an all-over spray or mist in a commercial spray “tanning” booth, it may be difficult to avoid exposure in a manner for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even internally.

Consequently, FDA advises asking the following questions when considering commercial facilities where DHA is applied by spraying or misting:

• Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves?
• Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane?
• Are consumers protected from internal exposure caused by inhaling or ingesting the product?

If the answer to any of these questions is “no,” the consumer is not protected from the unapproved use of this color additive. Consumers should request measures to protect their eyes and mucous membranes and prevent inhalation.

What about sunless tanning products sold in retail stores, such as creams and lotions?

DHA is approved for external application to the human body, which is the way these products are intended to be used. Consumers can easily avoid inhaling them or applying them to the area of the eye or mucous membrane.

Who is responsible for the safety of spray tanning booths?

The FD&C Act does not authorize FDA to approve cosmetic products or ingredients, with the exception of color additives that are not coal-tar hair dyes. Firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use and properly labeled. FDA can take action against firms and individuals who violate the law. The practice of administering such products by professionals, such as in salons, is generally the responsibility of local and state health authorities.

For more information about the regulation of cosmetic products and ingredients, see FDA Authority Over Cosmetics³.

Do sunless tanners and bronzers provide protection from the sun?

Sunless tanners and bronzers may or may not provide protection from the sun. Only those sunless tanners that contain sunscreen ingredients and are labeled with sun protection factor (“SPF”) numbers may provide protection. Consumers are advised to read the labeling carefully to determine whether or not these products provide protection from the sun.

All suntanning preparations that do not contain sunscreen ingredients are required to carry the following warning statement on the label:

“Warning–This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.” (21 CFR 740.19)

Sunscreens are regulated as over-the-counter drugs⁴ unless they are used in the product for reasons other than protecting the consumer from the sun, such as protecting the product itself from fading. Cosmetic products that are marketed with sun-protection claims, such as makeup labeled with SPF numbers, are regulated as both drugs and cosmetics.

Has FDA received reports of adverse reactions associated with sunless tanners?

FDA has received reports from consumers stating that they have experienced adverse events associated with sunless tanning, including rashes and, primarily in the case of spray tanning booths, coughing, dizziness, and fainting. It is uncertain what, if any, ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events, whether an individual’s allergic reaction might have played a part, or whether factors unrelated to the sunless tanning products may have been involved, such as pre-existing medical conditions.

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires ingredient declarations on cosmetics sold on a retail basis to consumers. In this way, consumers can know what ingredients are contained in the products they purchase and avoid ingredients to which they may be sensitive. However, the FPLA does not apply to products used exclusively by professionals, such as those used in spray tanning booths.

Read full story via Cosmetic surgery news

Read full story via 14 News

Never mind nose jobs. Women are increasingly opting for a much more radical form of cosmetic surgery–on their genitals. But, says Marge Berer, editor of the medical journal Reproductive Health Matters, these procedures, which are aimed at “beautifying” the labia, are tantamount to female genital mutilation – the shockingly primitive surgery performed on women in places like Africa and the Middle East for religious and cultural reasons. Hysterical overstatement? Berer says no.

via Plastic Surgery – Sexual Surgery – Genitals – Marie Claire.

Her procedure took place on Thursday, but was rushed to his hospital Sunday with an acute respiratory deficiency. She ultimately suffered an embolism and died.

Read full story via examiner.com

via  New York Times

Net income dropped to $45 million, or 15 cents a share, from $108 million, or 35 cents, a year earlier, the Irvine company said. Profit excluding some items was 55 cents a share, beating by 2 cents the average analyst estimate.

Read full article via  Los Angeles Times.