The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.

The FDA’s approval is based on six years of data from 955 women demonstrating that there is a reasonable assurance of safety and effectiveness for this implant. Mentor’s MemoryShape Breast Implant showed similar rates of complications and outcomes as previously approved breast implants. These complications include tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and wrinkling. Fissures or cracks were observed in the gel of some MemoryShape Breast Implants, a characteristic called gel fracture.

“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 the implants’ long-term safety and effectiveness.”

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

The FDA require

s that Mentor 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 Mentor’s MemoryShape Breast Implant.

As a condition of approval for the MemoryShape Breast Implants, Mentor must:

• Continue to follow 955 women who received the MemoryShape Breast Implants as part of the pre-market core study that provided safety and effectiveness data for the device approval. These patients will be followed until they have completed their 10-year evaluations for long-term device performance;

• Continue to follow approximately 350 subjects who were implanted with the MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants as part of a pre-market continued access study (not part of the pre-market core study). The patients will be followed until they have completed their 5-year evaluations;

• Conduct a new study of approximately 2,500 women receiving MemoryShape Breast Implants to collect information on long-term local complications (e.g., capsular contracture, re-operation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications). These patients will be followed for 10 years;

• Conduct five case control studies by enrolling 10,750 women to evaluate the potential association between any silicone gel-filled breast implant (including MemoryShape 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 MemoryShape Breast 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 reconstruction or augmentation. These implants come in different sizes and styles and have either a smooth or textured silicone outer shell that is filled with silicone gel.

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 five FDA-approved silicone gel-filled breast implant products available in the U.S. manufactured by three companies: Allergan, Mentor and Sientra.

Shoshana Rosenberg, ScD, of Dana-Farber Cancer Institute and Harvard School of Public Health, and her colleagues evaluated 277 women who were diagnosed with breast cancer at age 40 or younger, who reported having a choice between a mastectomy and a breast conserving lumpectomy, and whose cancer ranged from stage 1 to stage 3. She will present the findings (abstract 6507) on Monday, June 3, 10:15 am CT, S404, McCormick Place.

“Women diagnosed with breast cancer at an early age typically have a different set of medical and psychosocial issues and concerns than do older women,” said Rosenberg. “We were interested in learning from women who had a choice about surgery what factors were associated with their decisions.”

A lumpectomy involves surgically removing the tumor and some of the healthy tissue around it, but it typically spares most of the breast. It is standard to treat the area with radiation therapy following surgery to destroy any remaining cancer cells. A mastectomy removes most or all of the breast, and possibly chest muscle and some lymph nodes to prevent spread of the disease. Most women do not need radiation therapy after a mastectomy, though many chose to have additional surgery to reconstruct the breast. Studies have shown that the overall survival rates for lumpectomy followed by radiation compared with mastectomy are the same.

Overall, the researchers found that 172 of the women, or 62 percent, opted to have either a single or double mastectomy. Factors associated with choosing a mastectomy included having a genetic mutation, an overabundance of the HER2 protein in tumor cells, signs of spread to the lymph nodes, higher tumor grade, lower body mass index, having two or more children, increased anxiety, and greater patient involvement in the decision. Other factors of interest, including age, race, marital status, tumor size, having an estrogen-sensitive tumor, having a first degree relative with breast or ovarian cancer, fear of recurrence, and depression, were not significantly associated with having a mastectomy.

“Rates of mastectomy, particularly in young women with breast cancer, are on the rise, and it is not entirely clear why,” said Rosenberg. “Our data suggest that disease and genetic factors may be related to choice, as well as anxiety and how the decision was made. Further research is clearly warranted in an effort to help ensure women can make informed, quality decisions about their breast cancer therapy.”

Philadelphia, Pa. (May 29, 2013) – For women undergoing breast reconstruction after mastectomy, the weight of the tissue flap used affects the risk of an important complication called fat necrosis, reports a study in Plastic and Reconstruction Surgery-Global Open®, the official open-access medical journal of the American Society of Plastic Surgeons (ASPS).

Information on flap weight—and the number of blood vessels supplying the flap—can help plastic and reconstructive surgeons optimize outcomes for women undergoing breast reconstruction after mastectomy for breast cancer, according to the study by ASPS Member Surgeon Dr. Justin M. Sacks and colleagues from the Department of Plastic and Reconstructive Surgery at the Johns Hopkins School of Medicine, Baltimore.

Flap Weight and Blood Supply Predict Fat Necrosis Risk

The researchers analyzed risk factors for fat necrosis in 123 women undergoing breast reconstruction after mastectomy for breast cancer. Fat necrosis refers to the death of fat cells in the reconstructed breast; it is caused by problems with blood supply to the transplanted flap.

The reconstructions were performed using the women’s own tissues—specifically, using flaps of tissue transferred from the abdominal area. In performing autologous reconstructions, plastic and reconstructive surgeons create custom-designed flaps of muscle, fat and skin from the abdominal area, along with their supplying blood vessels.

Dr. Sacks and coauthors evaluated surgical and patient-related factors affecting the risk of fat necrosis after reconstruction—including the total weight of the abdominal tissue flap before it was transferred to the chest. The analysis included a total of 179 flaps (including 56 women undergoing reconstruction of both breasts).

Fat necrosis occurred in 7.5 percent of flaps overall. The risk was significantly higher for women with heavier tissue flaps: for each 100-gram increase in flap weight, the risk of fat necrosis increased by 50 percent. (The average flap weight was approximately 650 grams.)

Risk of fat necrosis was also affected by the number of supplying blood vessels, or “perforators”—especially in heavier flaps. Among flaps larger than 1,000 grams, the rate of fat necrosis was about 43 percent in those with a single perforator, compared to 14 percent for those with two or more perforators.

Attention to Risk Factors May Improve Breast Reconstruction Outcomes

African American women were also at higher risk of fat necrosis after breast reconstruction, with a risk nearly 12 times higher than in Caucasian women. Risk was not significantly affected by patient age, body weight, and various medical and surgical factors.

Fat necrosis is an important complication after breast reconstruction. “Development of fat necrosis requiring reoperation can result in significant aesthetic deformity as well as emotional and financial costs,” Dr. Sacks and coauthors note.

Plastic and reconstructive surgeons are constantly working to refine the technical aspects of breast reconstruction, including flap design, in order to provide the best possible surgical and aesthetic results. Although other studies have looked at risk factors for fat necrosis, the new study is the first to focus on the flap weight and its interaction with blood supply.

The results show that larger, heavier flaps are at higher risk of fat necrosis, particularly in flaps with just one perforating blood vessel. Dr. Sacks and colleague suggest that plastic and reconstructive surgeons should consider “balancing perforator number and increasing flap weight” in designing abdominal flaps for autologous breast reconstruction. They suggest to ensure adequate blood supply to flaps in African American women, who appear to be at higher risk of fat necrosis after breast reconstruction.

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 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.

“We are going to provide information in a way that’s never been done before on this level,” said ASPS President Malcolm Z. Roth. “A group of breast reconstruction patients will show a group of breast cancer patients what their reconstruction choices look like.  This is something that until now has been a taboo topic, and we want to give these women a forum to get the information they need.”

Many breast cancer patient organizations report that a majority of women want to go beyond the usual routine of looking at before and after photos, to actually seeing the real results of various breast reconstruction procedures, in person, and having a chance to discuss those results with breast cancer survivors who’ve had the procedure.

“It is our job as doctors to fully inform our patients about breast reconstruction options,” said Dr. Roth. “Women are telling us that they want to actually see what reconstruction results would look like beforehand, and as their physicians we need to do everything we can to honor their request.”

The survey, conducted by Harris Interactive, also found:

• Less than a quarter (23%) of women know the wide range of breast reconstruction options available.
• Only 22% of women are familiar with the quality of outcomes that can be expected.
• Only 19% of women understand that the timing of their treatment for breast cancer and the timing of their decision to undergo reconstruction greatly impacts their options and results.

Not only are some women never shown breast reconstruction surgery results, but previous research shows 7 out of 10 women diagnosed with breast cancer are never even told about their breast reconstruction options.**

Kim Sport, who survived two battles with breast cancer, had a mastectomy and breast reconstruction at the same time and is passionate about educating other women who are facing breast cancer.

“I feel that it is very important to share my experience with other women because I don’t want them to just have to look at a photo. I want to show them what reconstruction really looks like,” said Sport, who has shared her reconstruction results with small groups of breast cancer patients and looks forward to raising awareness in a bigger way on BRA Day.

ASPS Member Surgeon Frank DellaCroce, MD, who performed Kim’s reconstruction, believes that plastic surgeons should be a crucial part of any breast cancer patient’s team of caregivers.

“I see a great number of patients who come in and say ‘I wish I’d known about certain reconstruction options beforehand. I wish I could turn back the clock.’ But the problem is, you can’t turn back the clock,” said Dr. DellaCroce, who founded the Center for Restorative Breast Surgery in New Orleans along with ASPS Member Surgeon Scott Sullivan, MD.

The ASPS and The Plastic Surgery Foundation are launching BRA Day USA to kick off a new campaign to raise awareness about breast reconstruction options. Singer/songwriter Jewel is the spokesperson for the campaign and has written the inspirational song “Flower” to raise funds for the breast reconstruction awareness efforts.

“When I was writing this song there were a lot of survivors that came to mind and I’m always continually amazed at how resilient women are, and how when faced with a difficult position they find the courage to say, ‘I am going to fight on and I’m even going to be better.’ And that’s what made me want to write this song,” said Jewel.

Beginning today, Jewel’s song is available for download at iTunes. Jewel will also perform a charitable concert on October 29, 2012 in New Orleans during Plastic Surgery The Meeting. Event proceeds will be donated to the Breast Reconstruction Awareness Fund of The Plastic Surgery Foundation and be used to support national and local breast reconstruction organizations.

*Source: The survey was conducted online within the United States by Harris Interactive on behalf of ASPS from July 26-30, 2012 among 1,204 adult women ages 18 and older. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables, please contact the media representatives listed on this news release.

**Source: Cancer, February, 2008, Amy Alderman, MD

As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

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 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 three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.

“Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.” said Maisel.

The FDA based its Sientra approval on three years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.

In June 2011, the FDA released a report that included preliminary safety data from post-approval studies from earlier breast implant approvals. The experience collecting and analyzing data from these studies informed the design and structure of post-approval studies for Sientra breast implants.

In addition to other post-approval conditions, Sientra will:

• continue to follow the 1,788 clinical trial participants in their pre-market study for an additional 7 years;
• conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer; and
• conduct five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

“The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up,” said Maisel. “The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”

Sientra Inc. is based in Santa Barbara, Calif.

According to People magazine, comedian Wanda Sykes underwent breast cancer surgery in August after cancer was discovered as a result of her breast reduction surgery earlier this year.

During a September episode of The Ellen DeGeneres Show, Sykes told DeGeneres that when breast tissue that had been removed during her surgery was routinely sent to the laboratory, ductal carcinoma in situ was detected.

“We have been carefully watching the literature over the years linking macromastia to breast cancer,” Dr. Stevens said. “In addition to the obvious problems big breasts bring, such as back strain, bra straps cutting into the shoulders and difficulty exercising, cancer is seen more often in women with large breasts. Ms. Sykes’ experience is a classic example of the difficulty in diagnosing cancer in large-breasted women.”

Dr. Stevens did not treat Ms. Sykes, but he has had experience with similar cases.

“In addition, we find that women with large breasts are also very self-conscious about them. We have done many breasts reductions, and the women are overwhelmingly thrilled with the freedom of a smaller breast size,” Dr. Stevens says.

The risk of breast cancer should be a reason for large-breasted women to consider reduction surgery, said Dr. Stevens, founder of Marina Plastic Surgery.

“There have been multiple studies to compare breast cancer rates after breast reduction surgery. Statistics do show a decrease in breast cancer incidence in the breast reduction group,” Dr. Stevens says. “Certainly, there are other risk factors for breast cancer, so we support an all-out assault on the disease by looking for all factors.”

Risk factors include:

•     Alcohol use
•     Diet. Plant-based diets tend to be safer than meat-based ones.
•     Early menses and/or late menopause
•     Family history
•     No children or later child birth
•     Genetics
•     Hormones
•     Obesity
•     Age. The risk increases as women age.

Research has shown that immediate breast reconstruction after mastectomy improves psychological well-being and quality of life and provides women with improved body image and self-esteem compared with delaying the procedure.

However, data from this study, presented by Dawn Hershman, M.D., associate professor of medicine and epidemiology at Columbia University Medical Center in New York, indicate that only about one third of women undergo the procedure.

Hershman and colleagues identified 106,988 women with breast cancer who underwent mastectomy between 2000 and 2010. They identified these women using insurance codes and then examined data on the frequency of reconstruction by a number of factors including age, race, number of procedures performed in the hospital and type of insurance.

Of the women examined, 22.6 percent underwent immediate reconstruction. Although overall rates of reconstruction have increased since 2000, the greatest increases were seen among women with commercial insurance — from 25.3 percent to 54.6 percent — and among women aged younger than 50 years — from 29 percent to 60 percent. Among women aged 50 years or younger who also had commercial insurance, 67.5 percent underwent immediate breast reconstruction. Overall, women with commercial insurance had more than a threefold higher likelihood of undergoing immediate reconstruction compared with women without health insurance.

“We were surprised to see that although the use of immediate postmastectomy reconstruction has increased, the rates still remain low, with 41.8 percent of women aged younger than 50 years and less than 20 percent of women aged older than 50 years receiving reconstruction during this time frame,” Hershman said.

Researchers found that patients were more likely to undergo immediate reconstruction if their surgeon did more mastectomies or they were in a hospital where more mastectomies were performed.

“This is something that could be modified by training and patient education,” Hershman said.

Other factors associated with a decreased likelihood for undergoing mastectomy were increasing age, black race, rural hospital location, nonteaching hospital or having other medical illnesses.

Women who underwent immediate breast reconstruction postmastectomy did have a longer hospital stay, but in-hospital complication rates were similar between women who had reconstruction and those who did not.

“Our study shows that there are factors that can be modified to increase the likelihood that women undergo postmastectomy reconstruction,” Hershman said. “Public policy should ensure that access to reconstructive surgery is available to all women regardless of insurance status.”

In the future, Hershman and colleagues plan to explore other factors that may be associated with immediate reconstruction to better target interventions to appropriate institutions.

“The INSPIRA® range speaks to Allergan’s commitment to science-based innovation in the medical aesthetics category,” says Stu Fowler, President & General Manager, Allergan Canada. “Allergan has been a leader in this space for over two decades and we continue to assess, as well as respond to the needs of plastic surgeons using our products, and the needs of Canadian women interested in breast augmentation.”

Recent findings from the National Plastic Surgery Survey of 300 Canadian women, between the ages of 22 and 59, suggest that 87 per cent of women would like to change at least one part of their body.¹  Of the parts identified, breasts are the second leading feature that women would like to change after the stomach.²  In fact, 13 per cent of Canadian women have considered or are currently considering breast implant surgery, with women between the ages of 22 and 34 being seven times more likely to entertain the option of the procedure as compared to their older counterparts.³

According to the American Society of Plastic Surgeons, breast augmentation is the number one requested plastic surgery procedure in the United States.⁴  In addition, the American Society of Aesthetic Plastic Surgery estimates that breast augmentation accounts for roughly 20 per cent of all cosmetic surgical procedures performed in the United States with over 60 per cent of these using gel-filled implants.⁵

“Breast augmentation surgery has grown in popularity since silicone gel-filled breast implants first came to market in Canada,” says Dr. Julie Khanna, one of Canada’s leading cosmetic plastic surgeons and author of the book, Timeless Beauty.  “Surgeons are  looking for implant options that provide the best, individualized custom fit for their patients.  A woman’s relationship with her breasts is quite personal, so options like the INSPIRA® range are an important development for plastic surgeons today because they allow us to offer a more natural looking, tailored result.”

The INSPIRA® range offers over 300 next generation round, smooth and textured breast implant options, and has been available to patients outside Canada since 2006.^6,7

According to the National Plastic Surgery Survey, Canadian women cite improvement in self-esteem (34 per cent) as one of the key motivating factors to undergo a plastic surgery procedure.⁸ Forty-eight per cent say that whether the surgery will look natural impacts their decision to pursue the procedure.⁹

Silicone gel-filled breast implants were approved for use in breast augmentation, reconstruction and revision surgery in Canada in 2006.¹⁰ Following this milestone, Allergan launched the NATRELLE® Collection in 2007 as the country’s first recognizable brand name for Allergan’s wide range of high-quality gel-filled and saline-filled breast implants for Canadian women seeking this type of surgery.

Women looking for more information about the NATRELLE® Collection and INSPIRA® range or to find a qualified, board-certified plastic surgeon are encouraged to visit www.NATRELLE.ca.