Unnecessary Explantation of IDEAL IMPLANT Structured Saline Breast Implants Prompted byRadiologic Misdiagnosis of Rupture.

ABSTRACT: The unique dual-lumen and baffle design of the IDEAL IMPLANT Structured Saline breast implant gives it specific advantages over both silicone gel-filled and the original saline-filled implants. This internal baffle structure also gives it an appearance on various radiologic imaging studies that may be misinterpreted as a rupture because of similarities to the well-known radiologic appearance of a ruptured silicone gel implant. Patients may present with various misinterpreted imaging studies, highlighting the need for plastic surgeons and radiologists to be familiar with the normal appearance of the intact IDEAL IMPLANT and be able to distinguish it from a ruptured IDEAL IMPLANT. The radiology findings must be correlated with the clinical findings, or an intact IDEAL IMPLANT misdiagnosed as ruptured, may cause unnecessary patient worry, and may prompt unnecessary surgery for removal or replacement.

Ideal Implant Structured Breast Implants: Core Study Results through 10 Years.

BACKGROUND: The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection. METHODS: This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials. RESULTS: Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation. CONCLUSION: Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Splenic marginal zone B-cell lymphoma associated with ruptured breast implants: case report and review of the literature.

We describe splenomegaly and bilateral grade 2 Baker breast capsular contracture in a woman who had undergone augmentation mammoplasty. This case represents the first documented instance of splenic marginal zone lymphoma, and is among the rare reports of B-cell lymphoma, arising in a patient with breast implants.

New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants.

The IDEAL IMPLANT® Structured Breast Implant is a dual lumen saline-filled implant with capsular contracture and deflation/rupture rates much lower than single-lumen silicone gel-filled implants. To better understand the implant's mechanical properties and to provide a potential explanation for these eight-year clinical results, a novel approach to compressive load testing was employed. Multi-dimensional strains and tangent moduli, metrics describing the shape stability of the total implant, were derived from the experimental load and platen spacing data. The IDEAL IMPLANT was found to have projection, diametric, and areal strains that were generally less than silicone gel implants, and tangent moduli that were generally greater than silicone gel implants. Despite having a relatively inviscid saline fill, the IDEAL IMPLANT was found to be more shape stable compared to gel implants, which implies potentially less interaction with the capsule wall when the implant is subjected to compressive loads. Under compressive loads, the shape stability of a higher cross-link density, cohesive gel implant was unexpectedly found to be similar to or the same as a gel implant. In localized diametric compression testing, the IDEAL IMPLANT was found to have a palpability similar to a gel implant, but softer than a cohesive gel implant.

IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years.

BACKGROUND: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. The U.S. Food and Drug Administration and Health Canada granted approval in November of 2014. This implant is filled with saline but has an internal structure consisting of a series of nested shells that support the upper pole when upright and control fluid movement. It combines certain key features and benefits of saline and silicone gel implants. As with saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. As with silicone gel, it has a natural feel, but without the risk of silent rupture and U.S. Food and Drug Administration-recommended magnetic resonance imaging scans-women can simply look in the mirror and know their implants are intact. METHODS: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials. RESULTS: At 6 years, patient satisfaction was 89.7 percent for primary and 91.6 percent for replacement augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0 percent for replacement augmentation. Kaplan-Meier adverse event rates were as follows: Baker grade III and IV capsular contracture, 5.7 percent for primary and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8 percent for primary and 4.7 percent for replacement augmentation. CONCLUSION: Six-year results from 438 women show that the structured breast implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience.

BACKGROUND: High follow-up rates are critical for robust research with minimal bias, and are particularly important for breast implant Core Studies seeking U.S. Food and Drug Administration approval. The Core Study for IDEAL IMPLANT, the most recently U.S. Food and Drug Administration-approved breast implant, used a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials. METHODS: At enrollment, $3500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, the U.S. Food and Drug Administration published follow-up rates from Core Studies were compared for all currently available breast implants. RESULTS: Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9 percent and 96.7 percent, respectively) when compared to all other trials that have used U.S. Food and Drug Administration standardized follow-up reporting (MemoryShape, Allergan 410, and Sientra Core Studies). CONCLUSIONS: This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Two-year outcomes with a novel, double-lumen, saline-filled breast implant.

BACKGROUND: A double-lumen, saline-filled breast implant with a baffle structure (IDEAL IMPLANT Saline-Filled Breast Implant; Ideal Implant Incorporated, Irving, Texas) was developed to overcome the limitations of single-lumen saline implants by controlling saline movement and providing internal support to the implant edge and upper pole. OBJECTIVES: The authors report 2-year data from a 10-year US clinical trial evaluating the safety and effectiveness of this investigational implant. METHODS: Women seeking primary breast augmentation or replacement of existing augmentation implants were enrolled between February 2009 and February 2010 at 35 private practice sites, where the women underwent surgery to receive the new technology implant. Data collection included incidence and grade of capsular contracture (CC) and wrinkling as well as patient- and surgeon-reported satisfaction measures. All clinical data were reported as Kaplan-Meier risk rates of first occurrence, per patient, in each cohort. RESULTS: Two-year follow-up visits were completed by 472 of 502 enrolled women (94.0%), 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). Baker Grade III and IV CC rates were 3.8% (primary) and 8.2% (replacement), whereas moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Deflations occurred in 4.8% of primary augmentations and 3.3% of replacement augmentations. No deflations were caused by a shell fold flaw. CONCLUSIONS: Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of CC at 2 years than was reported for current single-lumen saline implants at 1 year.

Avian Flu pandemic in the United States. The Sanitec Industry's solution.

On the basis of the extensive testing of the Sanitec Industries, Inc. waste management system by the North Carolina State University, the authors of this Editorial strongly recommend the immediate implementation of the Sanitec medical waste disinfection system throughout the United States to prevent the potential pandemic of the Avian Flu viral infection.

Revolutionary advances in medical waste management. The Sanitec system.

It is the purpose of this collective review to provide a detailed outline of a revolutionary medical waste disposal system that should be used in all medical centers in the world to prevent pollution of our planet from medical waste. The Sanitec medical waste disposal system consists of the following seven components: (1) an all-weather steel enclosure of the waste management system, allowing it to be used inside or outside of the hospital center; (2) an automatic mechanical lift-and-load system that protects the workers from devastating back injuries; (3) a sophisticated shredding system designed for medical waste; (4) a series of air filters including the High Efficiency Particulate Air (HEPA) filter; (5) microwave disinfection of the medical waste material; (6) a waste compactor or dumpster; and (7) an onboard microprocessor. It must be emphasized that this waste management system can be used either inside or outside the hospital. From start to finish, the Sanitec Microwave Disinfection system is designed to provide process and engineering controls that assure complete disinfection and destruction, while minimizing the operator's exposure to risk. There are numerous technologic benefits to the Sanitec systems, including environmental, operational, physical, and disinfection efficiency as well as waste residue disinfection. Wastes treated through the Sanitec system are thoroughly disinfected, unrecognizable, and reduced in volume by approximately 80% (saving valuable landfill space and reducing hauling requirements and costs). They are acceptable in any municipal solid waste program. Sanitec's Zero Pollution Advantage is augmented by a complete range of services, including installation, startup, testing, training, maintenance, and repair, over the life of this system. The Sanitec waste management system has essentially been designed to provide the best overall solution to the customer, when that customer actually looks at the total cost of dealing with the medical waste issue. The Sanitec system is the right choice for healthcare and medical waste professionals around the world.

Use of UV-protective windows and window films to aid in the prevention of skin cancer.

People are exposed to ambient solar ultraviolet (UV) radiation throughout their daily routine, intentionally and unintentionally. Cumulative and excessive exposure to UV radiation is the behavioral cause to skin cancers, skin damage, premature skin aging, and sun-related eye disorders. More than one million new cases of skin cancer were diagnosed in the United States this year. UV radiates directly and diffusely scattered by the various environmental and atmospheric conditions and has access to the skin from all directions. Because of this diffuse UV radiation, a person situated under a covering, such as the roof of a car or house, is not completely protected from the sun's rays. Because shade structures do not protect effectively against UV radiation, there have been major advances in photoprotection of glass by the development of specially designed photoprotective windows and films. It is the purpose of this collective review to highlight the photoprotective windows and films that should be incorporated into residential, commercial, and school glass windows to reduce sun exposure. Low-emittence (low-E) coatings are microscopically thin, virtually invisible, metal or metallic oxide layers deposited on a window or skylight glazing surface to reduce the U-factor by suppressing radiative heat flow as well as to limit UV radiation. The exclusive Thermaflect coating uses the most advanced, double-layer soft coat technology to continue to deliver top performance for UV protection as well as prevent heat loss in the home. This product blocks 87% of UV radiation and has an Energy Star certification in all climate zones. Tints and films have been another important advance in glass photoprotection, especially in automobiles. Quality widow film products are high-tech laminates of polyester and metallized coatings bonded by distortion-free adhesives. The International Window Film Association provides members with accreditation in solar control films, safety films, and automotive films in an effort to increase consumer awareness and demand for all professionally installed film window products. The Skin Cancer Foundation has also played a leadership role in certifying window films that limit UV transmission. The Panorama Designer and Safety Films are currently recommended for UV photoprotection by The Skin Cancer Foundation. On the basis of these innovative scientific and industrial advances in window and film photoprotective products, we recommend that they be used in all residential, commercial, and school facilities to provide photoprotection in an effort to reduce skin cancer.

Photoprotection by sunscreens with topical antioxidants and systemic antioxidants to reduce sun exposure.

Skin cancer is the most common cancer diagnosed in the United States, and its incidence continues to rise. Epidemiological studies have documented that excessive sun exposure increases the risk of developing nonmelanoma skin cancer. Consequently, it is mandatory that the skin be protected from the damage that occurs from ultraviolet (UV) exposure. It is the purpose of this report to review the scientific basis for photoprotection by sunscreens, topical antioxidants, and systemic antioxidants to minimize the harmful effect of sun exposure. The US Food and Drug Administration regulates sunscreen products as over-the-counter drugs. Sunscreens are chemical or organic UV absorbers and nonchemical or inorganic UV absorbers. Other important sunscreen considerations include the sunscreen vehicle, sunscreen photostability, sunscreen preservatives, and sunscreen photoallergy and phototoxicity. Topical and systemic antioxidants have now been shown to supplement the photoprotective effects of sunscreen. The Skin Cancer Foundation, the only national and international nonprofit organization concerned exclusively with cancer of the skin, is playing a leadership role in eliminating skin cancer in our world.

National health strategies to reduce sun exposure in Australia and the United States.

Australia has developed a national health care policy that has made prevention of the occurrence of skin cancer a societal responsibility. Its strategies for skin cancer control have included careful documentation of the incidence of skin cancer over the last two decades. After realizing that the magnitude of sun exposure during childhood is a major risk factor in the development of skin cancer, Australia provides successful strategies to monitor and reduce the frequency of skin cancer. Early in the 1970s, education campaigns for the public as well as the healthcare worker were implemented that included booklets, posters, and teaching materials. This educational program allowed the public as well as healthcare workers to diagnose accurately the presence of skin cancer. In addition to identifying tumors at an early stage, Australia managed an exciting educational program on photodamage prevention. Australian standards governing ultraviolet radiation protection were incorporated into numerous comprehensive legislative bills that set standards for a wide variety of sun protective products to include sunscreens, photoprotective apparel, sunglasses, and occupational standards for sun exposure. On the basis of these comprehensive standards, the epidemic of skin cancer has been curbed, as documented. In contrast to Australia, the United States has relatively few comprehensive skin cancer prevention programs. These programs include the National Skin Cancer Prevention Educational Program, National Skin Cancer Prevention and Detection Month, The Skin Cancer Foundation's Self-Examination Program, and the State of California and US Food and Drug Administration Sunscreen legislation. It is difficult to measure the impact of these innovative efforts because there is not an accurate monitoring system for all skin cancers in the United States. However, the National Cancer Institute does determine the incidence of melanoma, which is reported annually by the American Cancer Society in their January/February issue of CA Journal for Clinicians. Statistics on other skin cancers are only projective. In the absence of an accurate, comprehensive statistical monitoring system for the frequency of skin cancer in the United States, as well as the limited legislative initiatives, it is difficult for organizations such as the American Academy of Dermatology, the American Cancer Society, the Centers for Disease Control and Prevention, and The Skin Cancer Foundation to ascertain the results of their efforts to prevent skin cancer. Consequently, the prevention of skin cancer in the United States is a personal rather than a societal responsibility.

Revolutionary advances in sun-protective clothing--an essential step in eliminating skin cancer in our world.

For many years, individuals around the world have relied on sunscreen alone as their primary form of protection against ultraviolet rays (UV-R). Australia has shown that a multitactic approach to skin cancer prevention, combining sun-protective clothing with sunscreen, can be both highly effective and widely accepted by the general public. In the US, the aging baby boomer generation and rising skin cancer epidemic call for a fundamental behavioral shift toward this combination approach to sun protection. Sun-protective clothing, such as that manufactured by Coolibar and awarded the Seal of Recommendation by The Skin Cancer Foundation, offers millions of Americans the opportunity to significantly improve the quality of their lives and is an essential step in eliminating skin cancer in our world. All Coolibar clothing products carry a minimum ultraviolet protection factor (UPF) rating of 30, blocking 97% UV-R or greater. Each product in the Coolibar clothing line is individually tested and rated for its UV protection level; this process is explained in a thorough hangtag attached to the product. This tag specifies what UPF the product has received, how the UPF is figured, which testing procedures the individual product was submitted to, and if that product has received the Seal of Recommendation from The Skin Cancer Foundation. In addition to photoprotective clothing, The Skin Cancer Foundation recommends Rit Sun Guard, a photoprotective laundry additive. Rit Sun Guard washes into the clothing fibers and absorbs broadband UV-R. A single treatment of Rit Sun Guard sustains a UPF of 30 for approximately 20 launderings. The active ingredient in Rit Sun Guard is TINOSORB FD. In order to be certified by The Skin Cancer Foundation, the Coolibar clothing product must undergo extensive UPF testing to confirm the accuracy of the product labeling. Laundry additives evaluated by The Skin Cancer Foundation undergo similar tests to that of photoprotective clothing after a uniform laundering method is used to apply the product to the clothing fibers. Both of these certification processes confirm the UPF, UV-A and UV-B transmittance, and percentage blocking UV-A and UV-B. The certification process is reviewed on an annual basis.

Management and prevention of tetanus.

The World Health Organization was committed to eliminating neonatal tetanus by 1995. Three years after this date, the infection killed over 400,000 babies a year, even though a safe, effective vaccine had been available for most of this century. The frequency of tetanus in the developing world epitomizes the healthcare disparity between the developed and the developing world. Consequently, the priority of the medical profession must be prevention, with the development of simpler immunization schedules with longer protection. Consequently, the purpose of this collective review is to provide an overview to the management of tetanus as well as to review the immunization strategy that will prevent this potentially deadly illness. Tetanus is caused by Cloistridium tetani, which is an obligate anaerobic, gram-positive rod that is motile and readily forms endospores. Although C. tetani is located everywhere, the disease is encountered largely in underdeveloped, overcrowded, and economically disadvantaged countries. C. tetani is widespread in the feces of domestic animals and humans, while spores of C. tetani are abundant in soil and in the environment surrounding the habitation of humans and animals. Tetanus usually follows deep penetrating wounds where anaerobic bacterial growth is facilitated. Three basic forms of tetanus may be distinguished: local, cephalic, and generalized. At least 80% of the cases are the generalized form. In the adult patient, the most characteristic sign of generalized tetanus is lockjaw, or trismus. The diagnosis of tetanus is most frequently made on clinical manifestations, rather than on bacteriologic findings. The three objectives of management of tetanus are: (1) to provide supportive care until the tetanospasmin that is fixed in tissue has been metabolized; (2) to neutralize circulating toxin; and (3) to remove the source of tetanospasmin. Because there is essentially no immunity to tetanus toxoid, the only effective way to control tetanus is by prophylactic immunization.

Iontophoresis versus subcutaneous injection: a comparison of two methods of local anesthesia delivery in children.

The relative efficacy of local lidocaine anesthesia administered by subcutaneous injection and by iontophoresis was studied in 13 pediatric renal dialysis patients (ages 11-19 years: mean age 15.8 years). Each patient served as his own control at 3 assessment periods. Each type of anesthetic delivery method was administered to either of 2 fistula sites. Patients used visual analogue scales to rate pain, anxiety, and satisfaction for each method. Behavioral observations were made by an observer and a nurse. Paired sample t tests were used to compare the 2 drug delivery methods for patient, observer, and nurse ratings across assessment periods. There were no significant differences between methods for ratings of anxiety before or during the procedure. The injection of lidocaine was rated as more painful by the observer and nurse (with a trend for patients) than the use of iontophoresis. But, the patients and nurse rated the injection method as more effective. Iontophoresis was never rated as superior to the injection method, even after turning over control of drug delivery by iontophoresis to the patient (sessions 2 and 3). Patients were more satisfied with iontophoresis at session 2 when they took over control, but lost enthusiasm by session 3. Three subjects withdrew from the study due to cutaneous burns and prolonged anesthesia delivery time with iontophoresis. Iontophoresis appears to be effective in reducing the pain of dialysis needle insertion but requires further investigation before it can be considered a viable alternative to subcutaneous injection.