Kansas City’s reputation is based on more than its barbecue and jazz!
FDA Approves Allergan’s Natrelle 410 Silicone-Gel Breast Implant; Establishes National Breast Implant Registry with the ASPS
Based on seven years of data from 941 women, the FDA has approved Allergan, Inc.’s Natrelle 410 silicone-gel breast implant for breast augmentation and reconstructive surgery. Allergan, as part of the FDA-approval process, has agreed to officiate over a series of post-approval studies. These studies will assess long-term safety, and effective outcomes as well as any associated risks with rare diseases.
According to Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, “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.”
Other conditions Allergan must meet for FINAL FDA approval include submission of a report based on a 10-year clinical study, and participation in developing the National Breast Implant Registry (NBIR) in collaboration with the FDA and the American Society of Plastic Surgeons (ASPA).
“At Premier Plastic Surgery we are very excited about the FDA announcement that the 410 cohesive gel implant is more widely available. I’ve used this implant for the last 7 years for breast reconstruction cases and the most complicated breast augmentation patients thru an FDA research protocol and I’m very happy the FDA has allowed the use of this implant for more straight forward breast augmentation cases. In plastic surgery there are numerous situations in which the quality of the final result depends in part on the devices and technologies available. While the cohesive anatomical implant won’t replace the round gel implant and is not appropriate for all, it will allow better final results for a significant group of patients.” - Dr. Brad Storm.
The basis of this registry is to track cases of breast implants among women, and create a device surveillance registry to collect data on short and long-term safety outcomes associated with breast implants. Overall, the main focus is to monitor the safety and efficacy of these devices in patients who have used them. Since initiating the 10-year profile study, a cooperative research and development agreement has been signed by the FDA and the ASPS. Review of historical data, discussions on the aggregation of data and validation of inquiries continue on a weekly basis.
According to Shuren, the FDA will continue to look at results from the post-approval study to rate long-term safety and effectiveness. The silicone gel used in the Natrelle 410 implant contains more cross-linking than Allergan’s previously approved implant, resulting in an implant that is significantly firmer. The Natrelle 410 breast implant is the fourth FDA-approved silicone gel implant to be available in the United States.
Dr. John B. Moore and Dr. Brad Storm have been named Kansas City Super Doctors by their peers in the January issue of KC Magazine.
Key Professional Media, Inc., asked doctors to nominate colleagues who they would choose for medical care. Doctors were evaluated in the categories of peer recognition, professional achievement and disciplinary history. The doctors were grouped into 42 specialties and those achieving the highest total points were selected for the award.
“It is gratifying to be recognized by one’s peers. This award is a reflection of the great staff and physicians here at PPS,” Dr. John B. Moore.
Dr. Brad Storm was voted as a Top Doctor by his peers in the January issue of 435 South Magazine.
More than 5,000 licensed doctors were surveyed in Kansas and Missouri and asked which doctors they would send a family member to within the area. Nominees were evaluated on the basis of the survey results, the legitimacy of their licenses, and their current standings with their state’s medical board.
“Obviously it’s very gratifying when our patients feel we’ve done a good job, but it’s particularly gratifying when my peer physicians who see a lot of work of other Plastic Surgeons voted me one of the top Plastic Surgeons in Kansas City, ” Dr. Brad Storm.
Labiaplasty, Vaginoplasty and Clitoral Unhooding
It has been common for almost a century to lift and tighten facial skin to reverse the signs of aging. Facial skin rejuvenation procedures have been widely accepted and gradually led to extending the same philosophy and surgical techniques to rejuvenation of other parts of the body such as tummy tucks, arm lifts and lower body lifts.
Recently, there has been an increased interest in and awareness of female genital surgery which can address both cosmetic as well as functional concerns.
Common Female Genital Rejuvination Procedures
There are three common female genital rejuvenation procedures that women are interested in:
- Labiaplasty (correction/reduction of inner lips)
- Vaginoplasty (restoration of contour and tightness)
- Clitoral unhooding (removal of excessive tissue)
Labiaplasty surgery addresses the enlargement of the inner lips (labia minora), which are of concern to many women. This enlargement develops in some women during puberty and may continue to be problematic from their teen years into adulthood. In other women, the enlargement occurs during the childbearing period and is of both cosmetic and functional concern. Enlargement of the labia can create irritation and pain in certain types of clothing and with certain activities.
Labiaplasty surgery can safely eliminate the unwanted tissue in the labial area with a resulting natural, aesthetically pleasing appearance. Today, this surgical procedure can be performed in a safe, confidential, and comfortable fashion with highly satisfying results.
Our Board Certified Plastic Surgeons also perform vaginoplasty and clitoral unhooding procedures. The vaginoplasty procedure can restore vaginal contour and tightness, which is sometimes lost after successive childbearing. The clitoral unhooding procedure is beneficial to some women who have excess tissue covering the clitoral organ preventing adequate stimulation during sexual activity. Many women find that this procedure can significantly enhance their sensitivity and their sexual experience.
For further information on female genital rejuvenation procedures, please refer to our Main Surgery Web Page on www.ppskc.com and go to the appropriate section on Female Genitalia Surgery. Or feel free to schedule a consultation with one of our Board Certified Plastic Surgeons or speak to our Cosmetic Consultant at 913.782.0707.
Premature skin aging isn’t inevitable! Premature skin aging is an unnatural acceleration of the natural aging process caused by sun exposure, environmental factors and unhealthy lifestyle choices. These factors contribute to what is termed premature or extrinsic aging. These factors cause a decrease in collagen production and a breakdown in elastin which reduces skin tugor causing visible wrinkles and a dull skin appearance.
Genetically we all do age, but this “healthy aging” (or intrinsic aging) is a normal process that occurs over time. This process begins in the mid-20s but typically does not begin to show on our faces until decades later, unlike premature aging. Have you ever noticed a mid 20 to 30 year-old who is beginning to show the signs of leathery, wrinkled skin? Regular tanning with exposure to UV rays is the primary culprit causing premature skin aging.
In addition to the fact that prematurely-aging skin is not inevitable, there is other good news. It is also preventable! The five major causes of premature aging, all of which are preventable, it is only up to you, include:
- Sun exposure. Sun damage causes brown age spots, wrinkles, spider veins, and a rough, blotchy appearance to your skin. UV exposure breaks down collagen and elastin, impairs the skin’s ability to repair itself and causes cancer.
- Smoking. Smokers are more likely to develop prematurely-aging skin and are prone to have more wrinkles and deeper wrinkles, leathery skin and a yellowish hue to their skin than non-smokers.
- Poor Diet and Lack of Exercise. Exercise helps keep muscles toned and stimulates blood flow that can contribute to the appearance of healthy skin. Poor diets can lead to a lack of important nutrients and vitamins that help your body’s ability to fight the free radicals that can have harmful effects on our skin’s appearance and aging.
- Lack of Sleep and Too Much Stress. Too little sleep shows up just where we don’t want it to…under our eyes with puffy, dark circles. And too much stress cause us to worry and frown resulting in unattractive frown lines.
- Exposure to the Elements. Proper protection against environmental exposure to cold winds and low temperatures which can dry out our skin is important. Dry skin can also be caused by forced air heating which decreases our skin’s natural oils and decreases our skin’s protective moisture levels.
If you have any concerns or questions regarding the prevention of prematurely aging skin or are interested in learning more about skin rejuvenation procedures for sun damaged skin, please call Premier Skin Care Center today for your complimentary consultation. Turn back the hands of time with one of our many skin care rejuvenation and maintenance products or treatments.