Dr. Chang is also the principal of Aesthetica Cosmetic Surgery & Laser Center in Leesburg, as well as the owner of Radiance Salon & Medi-Spa in Ashburn and Leesburg.

“Dr. Chang and I are thrilled to add the services of Medi Weightloss Clinics to those that we offer at Aesthetica and Radiance,” said Severo, who is the director of operations of Aesthetica, Radiance and Medi Weightloss Clinics.

“We have long recognized the need for a weight loss program to complement our cosmetic surgical and non-surgical services, as well as our spa and salon services.”

The common element of each business, according to Severo, is to help patients become their best selves. All three businesses are physician-supervised by Dr. Chang, who is board certified by the American Board of Plastic Surgery and a member of the American Society of Bariatric Physicians.

“The weight loss program is designed by experts in medicine and public health, nutrition, fitness, motivation and education,” Severo said. “We provide individual counseling and motivate you every step of the way. Our program gives you the advice and direction you need to reach and maintain your goal weight.”

For more information about Medi Weightloss, call 703-894-2249 or visit the website at: http://.mediweightlossclinics.com/locations/lansdowne.

Caption: SNARE proteins (red, green and blue objects) are molecules found at most synapses throughout the body. They are known for their role in helping nerve cells send messages by releasing neurotransmitters. Dr. Wu and his colleagues used Botox and similar toxins to show that SNARES may also be important for retrieving synaptic message carriers.
Credit: Courtesy of NINDS.

“The results were very surprising,” said Ling-Gang Wu, Ph.D., a scientist at NIH’s National Institute of Neurological Disorders and Stroke. “Like many scientists we thought SNAREs were only involved in fusion.”National Institutes of Health researchers used the popular anti-wrinkle agent Botox to discover a new and important role for a group of molecules that nerve cells use to quickly send messages. This novel role for the molecules, called SNARES, may be a missing piece that scientists have been searching for to fully understand how brain cells communicate under normal and disease conditions.

Every day almost 100 billion nerve cells throughout the body send thousands of messages through nearly 100 trillion communication points called synapses. Cell-to-cell communication at synapses controls thoughts, movements, and senses and could provide therapeutic targets for a number of neurological disorders, including epilepsy.

Nerve cells use chemicals, called neurotransmitters, to rapidly send messages at synapses. Like pellets inside shotgun shells, neurotransmitters are stored inside spherical membranes, called synaptic vesicles. Messages are sent when a carrier shell fuses with the nerve cell’s own shell, called the plasma membrane, and releases the neurotransmitter “pellets” into the synapse.

SNAREs (soluble N-ethylmaleimide-sensitive factor attachment protein receptor) are three proteins known to be critical for fusion between carrier shells and nerve cell membranes during neurotransmitter release.

“Without SNAREs there is no synaptic transmission,” said Dr. Wu.

Botulinum toxin, or Botox, disrupts SNAREs. In a study published in Cell Reports, Dr. Wu and his colleagues describe how they used Botox and similar toxins as tools to show that SNAREs may also be involved in retrieving message carrier shells from nerve cell membranes immediately after release.

To study this, the researchers used advanced electrical recording techniques to directly monitor in real time carrier shells being fused with and retrieved from nerve cell membranes while the cells sent messages at synapses. The experiments were performed on a unique synapse involved with hearing called the calyx of Held. As expected, treating the synapses with toxins reduced fusion. However Dr. Wu and his colleagues also noticed that the toxins reduced retrieval.

For at least a decade scientists have known that carrier shells have to be retrieved before more messages can be sent. Retrieval occurs in two modes: fast and slow. A different group of molecules are known to control the slow mode.

“Until now most scientists thought fusion and retrieval were two separate processes controlled by different sets of molecules”, said Dr. Wu.

Nevertheless several studies suggested that one of the SNARE molecules could be involved with both modes.

In this study, Dr. Wu and his colleagues systematically tested this idea to fully understand retrieval. The results showed that all three SNARE proteins may be involved in both fast and slow retrieval.

“Our results suggest that SNAREs link fusion and retrieval,” said Dr. Wu.

The results may have broad implications. SNAREs are commonly used by other cells throughout the body to release chemicals. For example, SNAREs help control the release of insulin from pancreas cells, making them a potential target for diabetes treatments. Recent studies suggest that SNAREs may be involved in neurological and psychiatric disorders, such as schizophrenia and spastic ataxia.

“We think SNARES work like this in most nerve cell synapses. This new role could change the way scientists think about how SNAREs are involved in neuronal communication and diseases,” said Dr. Wu.

Arm Lifts By The Numbers:ARLINGTON HEIGHTS, Ill., April 29, 2013 – New statistics released by the American Society of Plastic Surgeons (ASPS) show that arm lifts in women have skyrocketed more than 4,000 percent in just over the last decade. It is a trend fueled, in part, by sleeveless fashions for women and more focus on strong-armed celebrities. In 2000, more than 300 women got upper arm lift procedures. Last year, more than 15,000 did.

American Society of Plastic Surgeons Member Dr. David Reath examines a patient after arm surgery. Plastic surgery for better arms in women is surging. New statistics released by the American Society of Plastic Surgeons show that arm lifts in women have skyrocketed a staggering 4,378 percent in just over the last decade. It is a trend fueled, in part, by sleeveless fashions for women and more focus on strong-armed celebrities.
Credit: American Society of Plastic Surgeons

Procedures in 2012

• Overall: 15,457 – up 3% since 2011 / 4,473% since 2000
• Women: 15,136 – up 4,378% since 2000
• 98% of arm lift patients were women
• Most popular with patients over 40. The majority, 43%, of patients were ages 40 and 54, 33% were over age 55.
• Average surgeon fee: $3,939 / total spent on arm lifts: $61 million

Upper arm lifts can include liposuction or a surgical procedure known as brachioplasty, in which loose skin is removed from the back of the arms.

“Women are paying more attention to their arms in general and are becoming more aware of options to treat this area,” said ASPS President Gregory Evans, MD. “For some women, the arms have always been a troublesome area and, along with proper diet and exercise, liposuction can help refine them. Others may opt for a brachioplasty when there is a fair amount of loose skin present with minimal elasticity.”

Doctors say there is no single reason behind the increase, though celebrities from the White House to the red carpet may be having an influence. A recent poll* conducted on behalf of ASPS found that women are paying closer attention to the arms of female celebrities.

“I think we are always affected by the people that we see consistently, either on the big screen or on TV,” said ASPS Public Education Committee Chair David Reath, MD, based in Knoxville, Tenn. “We see them and think, ‘yeah, I’d like to look like that’.”According to the poll, women most admire the arms of first lady Michelle Obama, followed closely by Jennifer Aniston. Actresses Jessica Biel and Demi Moore, and daytime TV talk show host Kelly Ripa also got votes for their toned arms.

That’s just what happened to 24-year-old Natalie Robinson of Knoxville, who says she was inspired by the arms of the first lady. “I looked at Michelle Obama and said ‘Oh my gosh, I want her arms. When I first started losing weight and started to tone up, I had her image in my head.”

That was three years ago. Today, Robinson has lost more than 170 pounds and continues an amazing transformation through diet and exercise. But for all the weight she’d lost, Robinson says she still wasn’t entirely happy.

“I had a lot of excessive skin around my upper arms,” she said. “Every time I looked in the mirror there was a reminder of a heavier person and I just couldn’t get rid of it.”

That’s when Robinson contacted Dr. Reath, who performed her brachioplasty. “Natalie had the perfect arms for this procedure,” said Dr. Reath, “but it’s not for everybody.”

“It’s a trade off. We get rid of the skin, but we leave a scar,” he said. “So, as long as there’s enough improvement to be made in the shape of the arm to justify the scar, then it’s a great procedure.”A brachioplasty requires an incision from the elbow to the armpit, generally on the back of the arm, leaving a visible and permanent scar. For Robinson, the scar was much easier to deal with than the excessive skin, but Dr. Reath cautions patients to carefully consider the pros and cons before having an upper arm lift, particularly a brachioplasty.

Dr. Reath stresses the importance of proper diet and exercise as part of a healthy lifestyle to all his patients, but says some women simply can’t achieve the look they want on their own. Many who simply want to tighten and tone their upper arms, but don’t have a lot of excess skin, opt for liposuction instead of a brachioplasty.

“We are genetically programmed to have different accumulations of fat in different areas, and for some women the arms can be a problem area,” said Dr. Reath. “The arms are a very noticeable area and if excessive fat and skin are an issue, they tend to look more out of proportion than the rest of the body.”

That was certainly the case for Robinson, but not anymore. Robinson says she never expected surgery to make her arms perfect, just more normal. “Well-proportioned is what I was going for, and I’m very happy. It was well worth the investment,” she said. “I would do it again.”

The most frequently performed surgical procedure was breast augmentation. Cosmetic surgical procedures increased more than 3% in the past year, with almost 1.7 million procedures in 2012. Surgery accounted for 17% of all procedures performed representing 61% of total patient expenditures.  The top five surgical procedures were:

• Breast Augmentation: 330,631
• Liposuction: 313,011
• Abdominoplasty: 156,508
• Eyelid surgery: 153,171
• Rhinoplasty: 143,801

“In 2012, breast augmentation replaced liposuction as the most popular surgical procedure.  This might have something to do with the increased popularity in silicone gel implants since their return to the market in 2006,” said Leo R. McCafferty, MD, President of the American Society for Aesthetic Plastic Surgery. “According to the Society’s statistics in 2006, 383,886 breast augmentation procedures were performed and of those 81% were saline implants and 19% were silicone.  In 2012, 330,631 breast augmentation procedures were performed and of those only 28% were saline implants and 72% were silicone.”

Women had more than 9.1 million cosmetic procedures, 90% of the total. The number of cosmetic procedures for women increased over 252% from 1997. The top five surgical procedures for women were: breast augmentation, liposuction, tummy tuck, eyelid surgery, and breast lift.

Men had almost 1 million cosmetic procedures, 10% of the total. The number of cosmetic procedures for men increased over 106% from 1997. The top five surgical procedures for men were: liposuction, rhinoplasty, eyelid surgery, breast reduction to treat enlarged male breast, and ear shaping.

Americans spent almost $11 billion on cosmetic procedures in 2012. Of that total $6.7 billion was spent on surgical procedures; $2 billion was spent on injectable procedures; $1.8 billion was spent on skin rejuvenation procedures; and over $483 million was spent on other nonsurgical procedures, including laser hair removal and laser treatment of leg veins.

The most popular nonsurgical procedure was injections of Botulinum Toxin Type A (including Botox and Dysport). Cosmetic minimally-invasive procedures increased over 10 percent in the past year, with almost 8.5 million procedures in 2012. Nonsurgical procedures accounted for 83% of the total number of procedures performed representing 39% of total expenditures.  The top five minimally-invasive procedures were:

• Botulinum Toxin Type A:  3,257,913
• Hyaluronic Acid: 1,423,705
• Laser Hair Removal: 883,893
• Microdermabrasion: 498,821
• Chemical Peel: 443,824

This is the second year this survey asked the doctors for the total number of non-surgical procedures being performed in their practices by BOTH physicians and their physician assistants and nurse injectors.  When procedures performed by physician assistants and nurse injectors are included, the total number of cosmetic surgical and nonsurgical procedures performed in the United States in 2012 increases to 12.7 million. Below is the TOTAL number of procedures performed in the practices surveyed:

• Botulinum Toxin Type A:  4,125,179
• Hyaluronic Acid:  1,806,806
• Laser Hair Removal: 1,224,920
• Chemical Peel: 718,465
• Microdermabrasion: 672,430

The Aesthetic Society, which has collected plastic surgery procedural statistics since 1997, says the overall number of cosmetic procedures has increased 250% since the tracking of the statistics first began. “We are confident that these statistics continue to accurately report cosmetic procedure trends as performed by the physicians who are most likely to perform them,” said Dr. McCafferty, MD. “For the past 16 years, the interest in and demand for cosmetic plastic surgery has risen exponentially, a 250% increase in surgical and nonsurgical procedures, and our comprehensive statistics continue to show that.”

The Aesthetic Society partnered with RealSelf, the most visited online community for learning about and sharing information and results for medical-beauty treatments, to get information on patients’ first-hand experience with procedures.  The RealSelf ‘Worth It Rating’ printed in the statistics report reflects the combined opinions of thousands of RealSelf community members. Each member shares whether an elective surgery or treatment was “worth it”, all things considered.

About the ASAPS Cosmetic Surgery National Data Bank

ASAPS, working with an independent research firm, compiled the 16-year national data for procedures performed 1997-2012. A paper-based questionnaire was mailed to 23,000 board certified physicians (9,300 dermatologists, 8,300 otolaryngologists, and 5,400 plastic surgeons). An online version of the questionnaire was also available.  A total of 837 physicians returned questionnaires, of which 65 were retired or otherwise inactive during 2012.  Of the 772 active respondents, the sample consisted of 365 plastic surgeons, 286 dermatologists, and 121 Otolaryngologists).

Final figures have been projected to reflect nationwide statistics and are based exclusively on the board certified plastic surgeons; otolaryngologists; and dermatologists. The findings have been aggregated and extrapolated to the known population of 25,750 active physicians who are board certified in these specialties. Though the confidence intervals change by procedure, depending on the grouping’s sample size and the response variance, the overall survey portion of this research has a standard error of +/- 3.47% at a 95% level of confidence.

Even mild gynecomastia can have adverse psychological effects in boys, according to the study by ASPS Member Surgeon Dr. Brian I. Labow and colleagues of Boston Children’s Hospital. They believe their findings have important implications for early intervention and treatment, including male breast reduction in appropriate cases.

Study Shows Psychological Impact of Gynecomastia in Boys

The researchers administered a series of psychological tests to 47 healthy boys, average age 16.5 years, being evaluated for gynecomastia. The results were compared to those of a group of boys without breast enlargement.

Sixty-two percent of the gynecomastia patients had mild to moderate breast enlargement. As in previous studies, many of the boys with gynecomastia were overweight or obese: 64 percent, compared to 41 percent of the comparison group.

Patients with gynecomastia had lower scores on a standard quality of life assessment, indicating problems in several areas. Even after adjustment for weight and body mass index (BMI), the patients had lower scores for general health, social functioning and mental health. They also had lower scores for physical health, but this was attributed to being overweight.

Breast enlargement was also associated with lower scores for self-esteem. This, along with impairment in emotional areas of quality of life, appeared directly related to gynecomastia, rather than being overweight.

Boys with gynecomastia also scored higher on a test of attitudes toward food and eating. However, there was no difference in the rate of clinical eating disorders between groups.

Psychosocial Effects Independent of Gynecomastia Severity

The negative psychological effects of gynecomastia were similar for boys at different levels of severity. “Merely having gynecomastia was sufficient to cause significant deficits in general health, social functioning, mental health, self-esteem, and eating behaviors and attitudes compared with controls,” Dr. Labow and coauthors write.

Gynecomastia is benign enlargement of male glandular tissue that is very common in adolescent boys. Although breast enlargement usually resolves over time, the problem persists in about eight percent of boys. Typically, boys with gynecomastia who are overweight or obese may simply be advised to lose weight.

However, losing weight won’t correct the problem in patients who have true glandular enlargement, or in those with a large amount of excess skin in the breast area. As shown by the new study, patients with gynecomastia may experience emotional and self-esteem issues regardless of body weight or the severity of breast enlargement.

“As a result, early intervention and treatment for gynecomastia may be necessary to improve the negative physical and emotional symptoms,” Dr. Labow and coauthors state. They note that male breast reduction, performed by a qualified plastic surgeon, is typically a simple and safe procedure.

It may seem self-evident that breast enlargement could have a psychological and emotional impact on teenage boys. However, adolescent gynecomastia has historically been regarded as a “cosmetic” procedure, not reimbursed by most insurance plans. The researchers note that only 35 percent of adolescent boys undergoing surgery for gynecomastia at their hospital were covered by insurance, compared to 85 percent of girls undergoing breast reduction.

“Our results indicate that careful and regular evaluation for gynecomastia may benefit adolescents regardless of BMI status or severity of gynecomastia,” Dr. Labow and colleagues conclude. They call for further studies to evaluate the effects of male breast reduction, including its impact on physical and psychological symptoms.

The most frequently performed surgical procedure was breast augmentation. Cosmetic surgical procedures increased more than 3% in the past year, with almost 1.7 million procedures in 2012. Surgery accounted for 17% of all procedures performed representing 61% of total patient expenditures.  The top five surgical procedures were:

• Breast Augmentation: 330,631
• Liposuction: 313,011
• Abdominoplasty: 156,508
• Eyelid surgery: 153,171
• Rhinoplasty: 143,801

“In 2012, breast augmentation replaced liposuction as the most popular surgical procedure.  This might have something to do with the increased popularity in silicone gel implants since their return to the market in 2006,” said Leo R. McCafferty, MD, President of the American Society for Aesthetic Plastic Surgery. “According to the Society’s statistics in 2006, 383,886 breast augmentation procedures were performed and of those 81% were saline implants and 19% were silicone.  In 2012, 330,631 breast augmentation procedures were performed and of those only 28% were saline implants and 72% were silicone.”

Women had more than 9.1 million cosmetic procedures, 90% of the total. The number of cosmetic procedures for women increased over 252% from 1997. The top five surgical procedures for women were: breast augmentation, liposuction, tummy tuck, eyelid surgery, and breast lift.

Men had almost 1 million cosmetic procedures, 10% of the total. The number of cosmetic procedures for men increased over 106% from 1997. The top five surgical procedures for men were: liposuction, rhinoplasty, eyelid surgery, breast reduction to treat enlarged male breast, and ear shaping.

Americans spent almost $11 billion on cosmetic procedures in 2012. Of that total $6.7 billion was spent on surgical procedures; $2 billion was spent on injectable procedures; $1.8 billion was spent on skin rejuvenation procedures; and over $483 million was spent on other nonsurgical procedures, including laser hair removal and laser treatment of leg veins.

The most popular nonsurgical procedure was injections of Botulinum Toxin Type A (including Botox and Dysport). Cosmetic minimally-invasive procedures increased over 10 percent in the past year, with almost 8.5 million procedures in 2012. Nonsurgical procedures accounted for 83% of the total number of procedures performed representing 39% of total expenditures.  The top five minimally-invasive procedures were:

• Botulinum Toxin Type A:  3,257,913
• Hyaluronic Acid: 1,423,705
• Laser Hair Removal: 883,893
• Microdermabrasion: 498,821
• Chemical Peel: 443,824

This is the second year this survey asked the doctors for the total number of non-surgical procedures being performed in their practices by BOTH physicians and their physician assistants and nurse injectors.  When procedures performed by physician assistants and nurse injectors are included, the total number of cosmetic surgical and nonsurgical procedures performed in the United States in 2012 increases to 12.7 million. Below is the TOTAL number of procedures performed in the practices surveyed:

• Botulinum Toxin Type A:  4,125,179
• Hyaluronic Acid:  1,806,806
• Laser Hair Removal: 1,224,920
• Chemical Peel: 718,465
• Microdermabrasion: 672,430

The Aesthetic Society, which has collected plastic surgery procedural statistics since 1997, says the overall number of cosmetic procedures has increased 250% since the tracking of the statistics first began. “We are confident that these statistics continue to accurately report cosmetic procedure trends as performed by the physicians who are most likely to perform them,” said Dr. McCafferty, MD. “For the past 16 years, the interest in and demand for cosmetic plastic surgery has risen exponentially, a 250% increase in surgical and nonsurgical procedures, and our comprehensive statistics continue to show that.”

The Aesthetic Society partnered with RealSelf, the most visited online community for learning about and sharing information and results for medical-beauty treatments, to get information on patients’ first-hand experience with procedures.  The RealSelf ‘Worth It Rating’ printed in the statistics report reflects the combined opinions of thousands of RealSelf community members. Each member shares whether an elective surgery or treatment was “worth it”, all things considered.

Caption: Doctors removed a skin cancer from Carolyn Bohlmann’s nostril (left). Bohlmann underwent a new reconstruction procedure that required only one operation. The cosmetic result was judged to be good to very good (right).
Credit: University of Michigan

ARBOR, Mich. — The skin cancer growing on Carolyn Bohlmann’s nose was not a very aggressive variety. But it was deep and located right on her nostril. The tricky part was not so much removing it – MOHS surgery, the procedure Bohlmann had, is a fairly common outpatient procedure.

Bohlmann opted for a new reconstruction technique her surgeon, Jeffrey Moyer, M.D., was offering at the University of Michigan Comprehensive Cancer Center. Moyer removed some cartilage from behind Bohlmann’s ear and skin from her shoulder and shaped it to create a new nostril in the place where the tumor had been growing.

“It healed up nicely. You can see a bit of a wrinkle, sort of a raised wrinkle. No one notices it unless I say something about having a surgery,” says Bohlmann, 69.

Ten days after having the procedure done, she was back to work at the deli counter, where none of her customers said a word about her nose.

“The nose is a fairly complicated area to reconstruct,” says Moyer, an associate professor of otolaryngology at the U-M Medical School and the senior author on a paper that outlines this new technique.

The most common method for nostril reconstruction requires taking cartilage from one part of the body and skin from the cheek or forehead to create a special skin flap. The skin flap stays in place for about three weeks so that the blood vessels can grow in the new spot. It looks very conspicuous during that time. Then patients come back to the operating room where surgeons finish the procedure by removing the flap. The tissue and blood vessels have grown over the cartilage, ensuring everything stays in place. Typical results look good and the nostril functions correctly.

But what about patients who can’t – or don’t want to – endure two procedures?

Moyer and his team started with one key question: Do we really need that blood supply from the skin flap? Bohlmann was one of 20 patients to take part in a clinical trial to help answer that.

The new procedure skips the skin flap – and the need for a second procedure – but still appears to allow for the cartilage to take hold and keep its place without the nostril either collapsing or pulling up. On a 1-5 scale (1 is best), the average cosmetic result was judged a 2.3 – considered to be good to very good, with minimal scarring that was not distracting to the patient’s appearance. Bohlmann’s result was judged as a 2.5.

“This could save people a lot of effort and time. The last thing people want to do is return to the OR,” Moyer says. “It allows us to spare people multiple surgeries or a scar that dominates the cheek.”

Moyer says that the cheek flap technique has a somewhat better cosmetic result than his new procedure. But since many skin cancer patients are older, they often have other medical conditions that make that second procedure unadvisable.

“The incremental benefit with a cheek flap is not worth it for some patients. The ability to do something less but still get the same quality of results is important,” he says.

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.

Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market. Therefore, these implants cannot be directly compared to any previously FDA-approved implant.

The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.  Lessons learned from previous post-approval studies on silicone gel-filled breast implants informed the design of post-approval studies for the Natrelle 410.

As a condition of approval for the Natrelle 410 breast implants, Allergan must:

• Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;
• Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications);
• Conduct five case control studies to evaluate the possible association between the Natrelle 410 implants, as well as other silicone gel-filled breast implants, and five rare diseases—rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
• Evaluate women’s perceptions of the patient labeling; and
• Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and styles. They have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.

With today’s approval, there are now four FDA-approved silicone gel-filled breast implant products available in the U.S. manufactured by three companies: Allergan, Mentor, and Sientra.

Allergan Inc. is based in Irvine, Calif.

You may not know that FDA considers the inks used in tattoos to be cosmetics, and the agency takes action to protect consumers when safety issues arise related to the inks.

At the other end of the tattoo process, FDA also regulates laser devices used to remove tattoos.

FDA has cleared for marketing several types of lasers as light-based, prescription devices for tattoo lightening or removal. A Massachusetts company recently received FDA clearance to market its laser workstation for the removal of tattoos and benign skin lesions.

According to a poll conducted in January 2012 by pollster Harris Interactive, 1 in 8 (14%) of the 21% of American adults who have tattoos regret getting one. And the American Society for Dermatologic Surgery (ASDS) reports that in 2011, its doctors performed nearly 100,000 tattoo removal procedures, up from the 86,000 performed in 2010.

Unfortunately, removing a tattoo is not as simple as changing your mind.

Artists create tattoos by using an electrically powered machine that moves a needle up and down to inject ink into the skin, penetrating the epidermis, or outer layer, and depositing a drop of ink into the dermis, the second layer. The cells of the dermis are more stable compared with those of the epidermis, so the ink will mostly stay in place for a person’s lifetime. Tattoos are meant to be permanent.

An effective and safe way to remove tattoos is through laser surgery, performed by a dermatologist who specializes in tattoo removal, says FDA’s Mehmet Kosoglu, who reviews applications for marketing clearances of laser-devices.

Lasers Used for Decades
“Laser” stands for Light Amplification by Stimulated Emission of Radiation. Kosoglu says that pulsed lasers, which emit concentrated light energy in short bursts, or pulses, have been used to remove tattoos for more than 20 years.

However, it can be a painstaking process. “Complete removal, with no scarring, is sometimes not possible,” Kosoglu notes.

FDA clearance means this method for removing tattoos complies with agency requirements for safety and effectiveness, according to FDA dermatologist Markham Luke, M.D. Other methods include dermabrasion—actually “sanding” away the top layer of skin—and excision—cutting away the area of the tattoo and then sewing the skin back together.

There are also do-it-yourself tattoo removal ointments and creams that you can buy online. “FDA has not approved them, and is not aware of any clinical evidence that they work,” says Luke. In addition, Luke says that tattoo removal ointments and creams may cause unexpected reactions, such as rashes, burning, scarring, or changes in skin pigmentation in the process.

How Does It Work?
With laser removal, pulses of high-intensity laser energy pass through the epidermis and are selectively absorbed by the tattoo pigment. The laser breaks the pigment into smaller particles, which may be metabolized or excreted by the body, or transported to and stored in lymph nodes or other tissues, Kosoglu explains.

The type of laser used to remove a tattoo depends on the tattoo’s pigment colors, he adds. Because every color of ink absorbs different wavelengths of light, multi-colored tattoos may require the use of multiple lasers. Lighter colors such as green, red, and yellow are the hardest colors to remove, while blue and black are the easiest.

Does It Hurt?
“That depends on a person’s pain threshold,” Kosoglu says. Some people compare the sensation of laser removal to being spattered with drops of hot bacon grease or snapping a thin rubber band against the skin. A trained dermatologist will be able to adjust the treatment to the patient’s comfort level.

Generally speaking, just one laser treatment won’t do the trick. According to the American Academy of Dermatology, the procedure requires multiple treatments (typically six to 10) depending on a tattoo’s size and colors, and requires a few weeks of healing time between procedures. Some side effects may include pinpoint bleeding, redness, or soreness, none of which should last for long.

Luke says that these laser devices are cleared for use by, or under the supervision of, a health care professional. The removal procedure requires using the correct type of laser, understanding the reaction of tissue to laser, and knowing how to treat the area after the procedure.

“If you have any concerns about having a tattoo removed, it’s a good idea to consult your dermatologist, who is knowledgeable about laser treatments,” Luke concludes.

Injecting botulinum toxin A (BTA), or Botox, into the stomach had been believed to delay emptying of the stomach, increase feelings of fullness and reduce body weight. Researchers enrolled 60 obese patients in a 24-week, double-blind, randomized, placebo-controlled, concealed allocation trial to compare the effects of BTA to placebo. They found that the injection slowed movement of food through the stomach but it did not cause weight loss.

“On the basis of our findings, I would not recommend gastric Botox injections to people who want to lose weight. There are some risks with this treatment and we found that there was no benefit in terms of body weight loss,” said Mark Topazian, lead author of the study and professor of medicine in the Department of Gastroenterology and Hepatology at the Mayo Clinic, Rochester, MN.

A previous study had indicated that Botox was a promising weight loss option. This study invalidates those findings because it is larger, used ultrasound to ensure injections were properly placed, and limited bias by ensuring that neither physicians nor patients knew who received Botox and who received placebo injections.

“Unless future studies show different results I’d advise patients to seek other means of achieving weight loss,” said Dr. Topazian.