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Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act.

The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century. This tragedy occurred shortly after the introduction of sulfanilamide, the first sulfa antimicrobial drug, when diethylene glycol was used as the diluent in the formulation of a liquid preparation of sulfanilamide known as Elixir Sulfanilamide. One hundred five patients died from its therapeutic use. Under the existing drug regulations, premarketing toxicity testing was not required. In reaction to this calamity, the U.S. Congress passed the 1938 Federal Food, Drug and Cosmetic Act, which required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the Food and Drug Administration from that of a policing agency primarily concerned with the confiscation of adulterated drugs to a regulatory agency increasingly involved with overseeing the evaluation of new drugs. The Elixir Sulfanilamide tragedy, its effect on drug regulations, and the history of other diethylene glycol and diluent mass poisonings are discussed.

Drug Approval↗

Order for transitional class III devices; submission of safety and effectiveness information under section 520(1)(5)(A) of the Federal Food, Drug, and Cosmetic Act--FDA. Notice.

The Food and Drug Administration (FDA) is issuing an order requiring manufacturers of transitional class III devices to submit to FDA a summary of, and a citation to, any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i). This is the first step in the process of determining the appropriate classification of transitional devices under the Safe Medical Devices Act of 1990.

Documentation↗

Issues in the practice of cosmetic surgery: consumers' use of information and perceptions of service quality.

The information sources consumers use and consumers' perceptions of the quality of services they receive are examined in the context of breast augmentation surgery. Consumers who received breast implants for reconstructive purposes (i.e., after a mastectomy) were compared with those who received them solely for cosmetic purposes. Implications for health care marketers at a time of federal scrutiny are discussed.

Breast↗

[Onychomycosis--more than a cosmetic problem].

The author deals in the submitted paper with the problem of onychomycoses not only from the cosmetic but in particular from the medical aspect. Onychomycoses account for as many as 50% of all problems affecting nails and about 10% of skin diseases. Very frequently onychomycosis is associated with tinea pedis. The author deals in detail, based on data in the literature, with the aetiology and views regarding the pathogenesis of the disease. She mentions various external, internal and predisposing factors which are involved in the increasing number of onychomycoses in recent years. She describes the clinical picture of all four basic forms of the disease and analyzes differential diagnostic aspects. She describes in more detail other factors participating in the development of onychomycoses such as the host and site specificity, geographical conditions, age, sex, genetic factors and others. The author also draws attention to diagnostic laboratory difficulties, in particular identification by cultivation. In the conclusion she mentions contemporary possibilities of local and general treatment where in recent years substantial advances were made.

Diagnosis, Differential↗

Conforming regulations regarding removal of section 507 of the Federal Food, Drug, and Cosmetic Act; confirmation of effective date. Food and Drug Administration, HHS. Direct final rule; confirmation of effective date.

The Food and Drug Administration (FDA) published in the Federal Register of January 5, 1999 (64 FR 396), a direct final rule. The direct final rule amended FDA's regulations by removing references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. The direct final rule also removed references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. This document confirms the effective date of the direct final rule.

Anti-Bacterial Agents↗

Incontinentia pigmenti: overcoming cosmetic challenges.

Incontinentia pigmenti is a rare syndrome of genetic origin that affects the melanin production of the melanocytes in the epidermis or superficial dermis. It is an X-linked dominate disease with lethality in males. The syndrome presents with skin and dental manifestations similar to ectodermal dysplasia and congenital syphilis. However, dental alternatives for achieving esthetic reconstruction differ. This article illustrates a case of cosmetic rehabilitation of an 18-year-old woman with incontinentia pigmenti.

Adolescent↗

Developing confidence and competence in cosmetic dentistry.

When it comes to cosmetic or esthetic dentistry the old adage "beauty is in the eye of the beholder" should be a guiding principal when developing an outline of treatment for our patients. Frequently our patients come to us with requests for improving their smiles but uncertain as to exactly what they want or even worse that have expectations that we are unable to deliver. The path traveled from initial interviewing of the patient to completing each case can be fraught with pitfalls of disappointment unless a careful process of educating the patient and constant communication is followed.

Clinical Competence↗

[Study of tolerance and efficacy of cosmetic preparations with lenitive action in atopic dermatitis in children].

PURPOSE: In AD (atopic dermatitis), the barrier function of skin is impaired, causing dryness and vulnerability: the first-end point to achieve is restoring skin's function to avoid relapses. Our aim was to assess tolerability and effecacy of two cosmetics with moisturizing and lenitive action in subjects affected by AD. PATIENTS AND METHODS: We used a topical preparation (product A) and a new formulation of it (product B) containing glycyrrhetinic acid, alpha-bisabolol, squalene, oryzanol and hohoba-oil. Product B was then compared with a third one (product C), also based on glycyrrhetinic acid and bisabolol. 30 subjects, aged between 4 months and 16 years, were included in the study (13 girls and 17 boys), suffered from mild-moderate AD, not treated with steroids. Patients were treated twice a day for 21 days, as follows: 12 product A (Decortil lipocrema IDI Farmaceutici); 9 product B (Decortil crema, IDI Farmaceutici); 9 product B on the right and product C (Lichtena AI crema UCB Pharma) on the left. We also did: photografic documentation, SCORAD Index, evaluation of objective (erythema, exudation, excoriation, dryness) and subjective (itching and burning) simptomatology (scoring 0-3) and physiopatological cutaneous tests as TEWL (Trans Epidermal Water Loss), corneometry and pHmetry at beginning and at end of treatment. RESULTS: All groups improved both clinically and instrumentally. Corneometry increased, TEWL lowed and pH turned to normality. CONCLUSIONS: Product A is better for restoring cutaneous physiology, B resulted more efficient in rehydration, in acute phase and as emollient agent, whereas C has more lenitive action.

Adolescent↗

[Coenzyme Q10--its importance, properties and use in nutrition and cosmetics].

Coenzyme Q10, or ubiquinone, is a nutrient--a vitamin-like substance which plays a crucial role in the generation of cellular energy an in free radical scavenging in the human body. After the age of 35 to 40, the organism begins to lose its ability to synthesize Co Q10 from food and its deficiency develops. Ageing, poor eating habits, stress and infection--they all affect our ability to provide adequate amounts of Co Q10. Therefore Co Q10 supplementation may be very helpful for the organism. The present summarizing study reports the history of the discovery and research, properties, biochemical effects, dosage of Co Q10 deficiency in the human body. A possible use of Co Q10 as a dietary supplement and an ingredient for topical cosmetic products is described.

Aging↗

[Mini mid-line skin incision--a more cosmetic challenge for surgery of funnel chest: report of a case].

We performed a operation using a mini mid-line skin incision for ten-year-old male with funnel chest. The skin incision was made from the level of nipple to the lower end of the xiphoid process. He had sternal elevation as corrective surgery. There was no complication and he discharged at 11th day after surgery. We believe our method is more appropriate in fulfilling the cosmetic needs for the patient of funnel chest.

Child↗

An objective grading system for the evaluation of cosmetic surgical results.

An objective grading system for the evaluation of cosmetic surgical results is presented. The ideal result for the specific procedure is the standard against which the surgical result is evaluated. This is based on the concept that perfection is the lack of imperfection. The result is graded based on identification of imperfections or flaws that deviate from the ideal. All potential flaws can be classified under one of five possible flaw categories: malposition, distortion, asymmetry, contour deformity, and scar. Each flaw category is graded for severity: perfect, noticeable, obvious, and obvious and deforming. Each severity level is assigned a value: perfect, 0 points; noticeable, 1 point; obvious, 5 points; and obvious and deforming, 15 points. The total points under the flaw categories are added for the total score. A perfect result has 0 flaws and gets a score of 0. Scores of 1 to 4 are good results, 5 to 14 are mediocre, and 15 or greater are poor. The benefits of this grading system include the easy identification of deficiencies and result in easy implementation of a plan to eliminate the flaw in the future. It increases the critical observational acumen of the surgeon. It helps in the evaluation of the surgical procedure as it relates to the end result. It improves the result and it improves our ability to communicate results within our profession in a meaningful way.

Esthetics↗

[Oculoplastic surgery implies restoration to "normalcy". Cosmetic surgery is performed only for congenital malformations or disease].

Ophthalmic plastic or oculoplastic surgery is the current term for the surgical treatment of disorders of the eyelid, the lacrimal apparatus and the orbit. The most frequent causes are congenital malformations, malpositions, abnormal motility, tumors and injuries. A good functional result with the best possible appearance is the goal; cosmetic surgery is performed only when the underlying cause is a malformation or disease. Several specialties have qualifications relevant to this field or parts of it; this article describes the tasks of an ophthalmologist working in this field and what he can accomplish.

Adult↗

Cosmetic result in thyroid surgery,.

In a series of 306 consecutive patients who had thyroid or parathyroid surgery for benign or malignant lesions attention was paid to a technique in which particular emphasis was laid on meticulous haemostasis and suction drainage of the postoperative serosanguineous fluid. This not only reduced the morbidity associated with haematoma formation and infection but also contributed to a good cosmetic result.

Drainage↗

[Pharmaceutical, medical and cosmetic advertising in the revue "A Illustração (Paris, 1884-1892)].

Edited by a Portuguese publisher in Paris, in 15.000 copies, to be sold in Portugal and in Brazil, the revue A Illustração propagated the progress accomplished by French science and industry in the pharmaceutical, medical and cosmetic domaine. It followed with particular interest the work of Pasteur and nearly every advertisement that is published on the subject of health made reference to either medicine or products of French origin. Such advertisements reflect the great concern of the times with matters of hygiene, both public and private.

Advertising↗

Anterior retention with a reinforced composite resin splint after cosmetic orthodontic treatment.

Even in the most stable types of orthodontic treatment, any relapse at all may be unacceptable cosmetically. Through the placement of a reinforced composite splint, the teeth can be held in position and more significantly recontoured, thus augmenting the final result. Subsequent splint removal can be done incrementally 3 to 5 years after placement as the patient desires.

Acid Etching, Dental↗

Cosmetic treatment, autonomy, and risks: "if you don't do it, I'll go to a dentist who will".

Patient requests and treatment goals may exceed the limits of professional practice and may have an adverse effect on health. When doctors encounter these types of requests, they first must decide whether the patient has the capacity to consent to such care. In the case of child patients, no such capacity exists and surrogate consent to care must be, in the opinion of the doctor, in the child's best interests. Parents who request potentially harmful procedures for a child with no hope for any health care benefit should be refused politely. Adult patients who request harmful elective procedures for themselves also should be educated and helped to fully understand why the request represents substandard treatment. The long-term consequences of these requests must be detailed clearly for these patients. Elective cosmetic treatment that will lead to long-term adverse effects on function and health raises serious ethical concerns in which the principle of nonmaleficence likely will trump the patient's autonomy.

Adolescent↗

Excellent cosmetic and functional result achieved by vulvar reconstruction using a V-Y myocutaneous flap after vulvectomy and lymphadenectomy in a young woman with stage II vulvar cancer.

Vulvar carcinoma is currently accounting for 4% to 5% of all female genital tract malignancies. We report a 31-year-old woman with a 4-year history of vulvar pruritus and a progressively growing painless mass. The lesion was an invasive squamous cell carcinoma and contained oncogenic human papillomavirus (HPV) type 16. An excellent cosmetic and functional treatment result was achieved by radical vulvectomy with selective inguinal-femoral lymphadenectomy (using separate incisions) followed by immediate reconstructive surgery using a V-Y myocutaneous flap.

Adult↗