Are Silicone Breast Implants Safe?

Silicone Breast Implants NYCBreast augmentation, or the enlargement of breasts with saline implants or silicone implants, is the most common cosmetic surgery procedure performed in the United States today.  There were more than 318,000 breast augmentation procedures performed in 2010 according to the American Society for Aesthetic Plastic Surgery. Additionally, according to the American Society of Plastic Surgeons there were more than 93,000 breast reconstruction procedures performed in the United States in 2010. Until November 2006, the majority of breast implants in the USA were saline implants; it is now estimated that approximately one half of all breast procedures today are performed with silicone gel breast implants, and the other half with saline breast implants.

Why the shift, and are silicone breast implants safe?

In April 1992, there was a moratorium placed on breast augmentation with silicone implants by the FDA because the premarket approval applications from the major manufacturers of silicone breast implants were felt to have been deficient of the necessary data to support approval.  After years of adjunct studies conducted by Allergan (Inamed/McGhan) and Mentor Corporations, in November 2006, the FDA approved silicone breast implants manufactured by both Allergan and Mentor (the Allergan Natrelle breast implant, and the Mentor MemoryGel breast implant).

As a condition of approval for silicone breast implants, each manufacturer was required to conduct a series of post-approval studies to evaluate the safety and performance of the breast implants. In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants, which presented preliminary data from the post-approval studies, a summary of adverse events, and a literature review.

The summary of the preliminary findings included in the FDA silicone breast implant update is as follows:

  • Silicone breast implants appear to have a reasonable assurance of safety and effectiveness when used as labeled.
  • Although local complications can and do occur, the benefits and risks of breast augmentation with silicone breast implants are sufficiently well understood for women to make informed decisions regarding breast implant surgery.
  • The longer a woman has breast implants, the more likely it is that she may experience local complications or adverse outcomes.
  • Women with breast implants will need to monitor their breasts for the rest of their lives.
  • The most frequent complications and adverse outcomes experienced by patients with breast implant include capsular contracture, reoperation, and implant removal (with or without replacement).
  • Other complications can include, but are not limited to, implant rupture, wrinkling, asymmetry, scarring, pain, and infection. These possible outcomes are consistent with those that were known at the time of initial approval in 2006.
  • ALCL, a very uncommon type of lymphoma, has been identified in a possible 60 cases among the estimated 5-10 million women with breast implants worldwide.  Albeit increased compared to women without breast implants, no causal relationship has been established.
  • Between 20 to 40 percent of breast augmentation patients and 40 to 70 percent of breast reconstruction patients had reoperations by 10 years.  Included in these breast implant “reoperation” statistics are also those who desired size change, or experienced breast changes such as droop (breast ptosis) or gland involution (shrinkage) due to weight loss or pregnancy.
  • There is no apparent association between silicone gel breast implants and connective tissue disease, breast cancer, or reproductive problems.
  • MRI is the most effective method of detecting silent (asymptomatic) rupture of silicone breast implants.
  • The data from the silicone gel breast implant post-approval studies may be limited due to low follow-up rates.

For women who have silicone breast implants, or for those who are considering breast augmentation with silicone breast implants, the following is recommended:

  • Be aware that breast implants are associated with the potential for local complications.
  • The longer breast implants remain implanted, the more likely it may be that an adverse event or additional surgery will be required.
  • Routine follow-up with your physician is a must.
  • Periodic MRI exams after breast augmentation with silicone implants are recommended. Ideally, a baseline MRI is performed at year three following breast augmentation, and every two years thereafter.
  • Notify your doctor if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling.
  • Recognize that breast implants are not lifetime devices. The longer you have your breast implants, the more likely it will be that they need to be removed or replaced.
  • If you have enrolled in a post-approval study, continue to participate.
  • Continue routine screening mammography at intervals recommended by your doctor based on your age and risk factors.

Based on the evidence to date, the FDA believes that silicone breast implants have a reasonable assurance of safety and effectiveness when used as labeled, and that although local complications and adverse outcomes can and do occur, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.

Both saline breast implants and silicone breast implants are man-made devices, and as such, it must be assumed that they will not last forever.  Silicone breast implants have an advantage of a more natural feel, are less prone to edge rippling, and appear to have a low rate of rupture or leak, however a higher level of vigilance is required, as, unlike a saline breast implant that “deflates” with a shell compromise, a silicone implant leak may be “silent”.  Silicone implants leak very infrequently, with an incidence that may be less than 1% per year.  What happens if a silicone breast implant does leak? Is it dangerous?  Based on available data, silicone is bio-inert, and is not causally associated with any medical conditions, but a breast implant that has ruptured should nevertheless, once diagnosed, be removed or replaced.  Indeed, as with any surgical procedure, the benefits, risks, and alternatives to breast augmentation with silicone breast implants must be fully and frankly discussed with a board certified plastic surgeon.  Every individual’s goals are unique, and an appropriate surgical plan must be carefully considered for every woman based on her particular health profile, anatomy, and desires regarding breast enlargement with breast implants.  To learn what options are best for you, it is recommended that you consult with a plastic surgeon who is certified by the American Board of Plastic Surgery, the only Board sanctioned by the American Board of Medical Specialties to certify, maintain and uphold the rigorous requirements for certification of plastic surgeons.

Scarless Surgery: Fact or Fiction?

Scarless Plastic Surgery NYCAchieving effective, long lasting results through plastic surgery without scars is the desire of many individuals contemplating plastic surgery, and the quest of all plastic surgeons.  Is scarless surgery actually achievable?

If one searches the terms scarless surgery, scarless plastic surgery, or scarless breast surgery on the internet, one may find approximately 500,000 sites, most purporting to deliver results without scars. It is beholden upon physicians to advise their patients honestly and ethically, and in truth, no surgery is scarless.

Indeed, there are non-surgical means of rejuvenation that do not make use of an incision.  Restylane and Juvederm treatments are extremely effective in the correction of facial lines and wrinkles, and in volume restoration.  Similarly, Botox Cosmetic treatments are also effective in relaxing the muscle action that creates dynamic wrinkles of the forehead and around the eyes.  These treatments are performed with tiny needles, and do not require surgery in the classic form. Resurfacing treatments such as chemical peels, dermabrasion, non-ablative laser and ablative laser therapy are also scarless, per se, but have as their most significant effects changes in the color and texture of skin.

Can a neck or face be rejuvenated without a scar? What about a scarless breast lift? As one moves up the proverbial ladder, there are minimally invasive treatments that may leave tiny scars.  Suction assisted lipectomy, or liposuction, is a technical approach to the reduction of excess fat that may yield mild consequent tightening in certain areas of the body, breast, or neck.  This type of treatment may be more or less effective in selected individuals.  But, simply put, when it comes to the need to restore position, to reduce extra skin, or both, there is no substitute for surgical intervention.

In breast plastic surgery, the trend over the last decade has been for the dramatic reduction in the length of incisions.  Breast augmentation, or breast enlargement with implants, can be performed with a minimal or inconspicuous scar.  Most often hidden in the crease below the breast (inframammary crease breast augmentation), or with an incision along the margin of the areola (periareolar breast augmentation).  Breast augmentation can also be performed using a “distant” site, such as the underarm (transaxillary breast augmentation) that allows for the entirety of the pocket creation beneath the muscle (subpectoral breast augmentation) using a specialized camera (endoscopic breast augmentation) and the placement of saline or silicone breast implants through a small fold within the underarm. This truly results in a scarless breast, although a small scar is required elsewhere.  With the rising popularity and safety of fat grafting, certain individuals may be candidates for a virtually scarless breast augmentation that is performed by the harvesting of fat cells from the torso or thighs using liposuction and the preparation and transfer of these cells to the breast (breast augmentation with autologous fat grafts). Only tiny needle-access sites are required for both harvest and transfer of the fat grafts.

Breast lift surgery and breast reduction surgery can both be achieved through short scar techniques in selected individuals.  Depending upon the degree of breast droop, deflation, or excess, short scar breast reduction or short scar breast lift can be achieved with either a circle around the areola (circumareolar breast reduction or circumareolar mastopexy), a circle around the areola intersecting with a vertical line (circumvertical or lollipop breast lift or breast reduction), or the latter with a small intersecting line in the inframammary crease region.  Often, restoring some volume to the breast with breast implants can mitigate the length of breast lift scars.

Can a facelift or necklift be performed without scars?  There has been a paradigm shift in facial rejuvenation that has brought us to a more “volumizing” approach; in that faces look more youthful with “fullness” rather than “tightness”, the use of fat grafts for the face and the reduction of scars and scar length is the rule.  Although many individuals are candidates for autologous fat grafting with or without short scar face lift or short scar neck lift techniques, these maneuvers may not be applicable to all.  Your board certified plastic surgeon will be able to advise you best after a thorough history and physical examination.

With regard to body contouring, the removal of excess fat is possible with minimal-scar techniques through liposuction.  When an imbalance exists, or is anticipated, between skin excess and the soft tissue support beneath, a scar is most often required.  Abdominoplasty can be performed with limited scars in the appropriate individuals.  In cases of massive weight loss through diet and exercise, or through bariatric surgery such as lap band or gastric bypass, longer scars are often required, but their placement can be oriented such that they are made as inconspicuous as possible. Lower body lift, brachioplasty (arm lift), and thigh lift are all performed using the most limited scars that are necessary to “tailor” the skin excess.

How do you know which plastic surgery procedure, or combination of procedures, is most appropriate?  How do you know if you are a candidate for “scarless”, minimally invasive, short scar plastic surgery, or more classic surgical approach?  A Board Certified Plastic Surgeon, who is certified by the American Board of Plastic Surgery, and a member of the American Society of Plastic Surgeons, will be best able to hear your concerns and desires, thoroughly evaluate you, and recommend the safest and most effective course of treatment to achieve your goals.

Treatments for Aging Hands

While the rejuvenation of the face with plastic surgery and other non-invasive techniques has been widely accepted and enjoys ever-increasing popularity, there is an area where certain tell-tale signs of aging have been historically overlooked: the hands.  Skin color, texture and volume changes of aging hands can look “out of place” when face, neck and body youthfulness is maintained or restored.

There is a wide array of pro-active as well as corrective measures available to refresh and rejuvenate the hands. Pre-emptive measures that protect against photoaging are extremely important. First and foremost, sunblock with an SPF of 30 or higher with broad-band UVA and UVB protection is integral to pre-empt the sun’s damaging rays.

Once discolorations and aging skin have become manifest, there are a variety of skin care treatments, cosmetic laser resurfacing treatments, chemical peels, and cosmetic surgery injectable treatments available that are highly effective at improving skin health and promoting a youthful appearance of the hands. Products that minimize and balance pigment including Hydroquinone, Kojic Acid, retinoids and Retin – A (derivatives of Vitamin A) will lighten hyperpigmentation (brown discolorations of the skin) and will promote collagen restoration.

Laser-light treatments are highly effective at reducing discolorations and balancing the tone of the skin of the hands. Intense Pulsed Light (IPL) is a no-down-time light-energy treatment that can dramatically decrease pigmentation due to sun damage. Fractional Photothermolysis, which are CO2 laser resurfacing treatments that are fractionated, treat sun-damaged skin with a much more rapid recovery than older laser modalities.  These treatments not only decrease brown spots and balance sun-associated discolorations, but produce a reorganization of the collagen layers of your own skin and result in a fresher, more rejuvenated appearance.

Chemical peels that incorporate alpha and beta hydroxy-acids, TCA, phenol, and Jessner’s solution can help to both exfoliate the damaged outer layer of skin (the stratum corneum) as well as to lighten dark pigmentation of the hands associated with the effects of the sun.

As one the obvious signs of hand aging is loss of volume, restoring that volume using one’s own fat is extremely effective. Known as autologous fat transfer or fat grafting, this technique of restoring volume to the hands can be achieved by the gentle harvesting and preparation of fat and associated stem cells (through specialized liposuction from the torso or lower extremities) and the transfer of these fat cells as fat grafts to the hands.  There is evidence that stem cells are also present when performing autologous fat grafts, which leads to both volume as well as more superficial improvements of the hands.

Which are the best plastic surgery treatment options for the hands? Combing at-home skincare preparation and treatment, color and textural modification with laser resurfacing and chemical peel treatments, and volume restoration with liposuction and fat grafting are ideal in achieving the most dramatic aesthetic improvements of the hands. As every individual’s needs are unique, a personal assessment by a board certified plastic surgeon is recommended to evaluate and discuss the benefits and alternatives of a variety of non-surgical and surgical techniques for hand rejuvenation.  Board certified plastic surgeons are certified by the American Board of Plastic Surgery, the only Board recognized by the American Board of Medical Specialties to certify plastic surgeons, which maintains the most rigorous standards of training and continuing education.

Cosmetic Treatments for Men

Cosmetic Surgery for MenFrom grooming and diet to sports and exercise, men’s desires for looking and feeling younger and healthier have been steadily increasing.  According to the American Society for Aesthetic Plastic Surgery, the number of cosmetic procedures performed in men has increased approximately 88% over the past decade.  In 2010, men had over 850,000 cosmetic procedures, approximately 8 percent of the total.

The top five plastic surgery procedures for men were: liposuction, rhinoplasty, eyelid surgery, breast reduction to treat enlarged male breasts (gynecomastia surgery), and ear reshaping (otoplasty). The number of liposuction procedures in men was 37,000, rhinoplasty 31,000,  blepharoplasty (eyelid lift) 21,000, gynecomastia or male breast reduction 18,000, and otoplasty 11,000. The frequency of facelifts for men was approximately 10,000 cases last year.

While cosmetic surgery is highly effective, many men continue to opt for a no- or minimal-downtime alternative.  Nonsurgical, injectable treatments like Botox and Dysport, which relax muscle action and smooth wrinkles, and injectable fillers, such as Juvederm, Restylane, Radiesse, Sculptra, Selphyl, autologous fat grafts, and others restore volume beneath and within a wrinkle or facial fold to naturally smooth contours.  Botox for men was performed 225,000 times, Juvederm and Restylane 70,000, and IPL (intense pulsed light), microdermabrasion, and laser skin resurfacing, approximately 35,000 each.

With so many choices, which ones are the best plastic surgery and treatment options for men? After a personal assessment by a board certified plastic surgeon, the benefits and alternatives of a variety of techniques will be discussed.  Board certified plastic surgeons are certified by the American Board of Plastic Surgery, the only Board recognized by the American Board of Medical Specialties to certify plastic surgeons, which maintains the most rigorous standards of training and continuing education. From at-home skincare to minimally invasive cosmetic treatments to aesthetic surgery, anything from subtle rejuvenation to dramatic changes can be achieved.