Breast 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.
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From 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.