Post-termination contraception: use of the Multiload Cu250

Summary. During a period of 27 months Multiload intrauterine devices were inserted immediately after suction evacuation of the uterus into 125 patients in two hospitals. Sixty-one patients were lost to follow-up despite careful explanation of the need to attend. The remaining 64 patients provided a total of 630 women months for analysis. Eleven patients requested removal of the Multiloads for various personal reasons. Four devices were spontaneously expelled, three in the first 2 months. Eight devices were removed on account of pain or bleeding and one because of infection. Five other patients were considered to have less severe uterine infection not requiring removal of the devices. These complications have to be viewed against those inherent in the procedure of termination: 4·4% pain or bleeding 3·6% uterine infection. Forty women are known to be continuing to wear the devices. They show no differences in terms of parity, gestation at the time of termination or degree of dilatation of the cervix at the time of termination from the other groups. One pregnancy occurred after 10 months of use. While acknowledging the deficiency of the study due to the high defaulter rate the immediate insertion of a Multiload at the time of termination of pregnancy can be considered as an acceptable method of contraception.     

Twelve-Month Persistency of a Novel Ribose–Cross-linked Collagen Dermal Filler

BACKGROUND The porcine collagen–derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities.
OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.).
METHODS & MATERIALS Subjects with moderate to deep nasolabial wrinkles ( n =149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR.
RESULTS Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced.
CONCLUSION The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non–touch-up subjects.     

Overtreatment Effects Associated with a Radiofrequency Tissue Tightening Device: Rare, Preventable, and Correctable with Subcision and Autologous Fat Transfer

Device complication rates were analyzed in the Regulatory and Quality Assurance departments of Thermage, Inc., Hayward, CA, USA, in consultation with Dr. Whitney D. Tope. Corrective treatment in the case study was performed at the Dermatology Surgery and Laser Center, White Plains, NY.     

A 20-Year Follow-up of Children with a Partial Thoracic Stomach (Hiatal Hernia)*

Carre, I., Astley, R. and Langmead-Smith, Rhoda (1976). Aust. paediat. J., 12, 92–94. A 20-year follow-up of children with a partial thoracic stomach (hiatal hernia). A preliminary report is presented of a long-term prospective study undertaken to ascertain the prognosis of children with a partial thoracic stomach (hiatal hernia) beyond childhood. This survey relates to 94 children who were originally studied by two of the authors (I.C. & R.A.) during 1950–1955. These patients had either received no specific treatment or had been managed conservatively by postural therapy. Although over 90% were free of symptoms, about one half still had a well defined intrathoracic gastric loculus on fluoroscopic examination.     

In Vivo and in Vitro Percutaneous Absorption and Skin Evaporation of Isofenphos in Man

Studies were done to determine the percutaneous absorption ofisofenphos in human volunteers from whom informed consent hadbeen obtained. In vivo absorption in man was 3.6±3.6%of applied dose for 24-hr exposure and 3.6±0.5% for 72-hrexposure. Skin wash recovery data show that isofenphos evaporatesfrom in vivo skin during the absorption process; the surfacedose is minimal (<1%) by 24 hr. Skin stripping showed noresidual isofenphos in stratum corneum. This explains the similarabsorption for 24 and 72-hr dose prewash exposures. Skin surfacerecovery in vivo with soap and water was 61.4±10.4 forthe first dosing time (15 mm). Time-recovery response declinedwith time to 0.5±0.2% at 24 hr. In vitro absorption utilizingflow-through diffusion methodology with human cadaver skin andhuman plasma receptor fluid gave 2.5±2.0% dose absorbed,an amount similar to In vivo studies. An additional 6.5±24%was recovered in the skin samples (total of 9%). Skin surfacewash at 24 hr recovered 79.7±2.2% and skin content was6.5±2.4% (total dose accountability of 88.7±4.6%).Thus, isofenphos was available for absorption during the wholedosing period. Neither in vitro absorption nor in vitro evaporationstudies predicted the potential skin evaporation of isofenphos.Published dermal studies in the rat had predicted isofenphosabsorption at 47% of applied dose (12-fold greater than actualin man). Subsequent toxicokinetic modeling predicted possibleconcern with the use of isofenphos. This is an example wherethe choice of the rat produced a nonrelevant absorption prediction.In vivo studies in human volunteers seem more relevant for predictingpercutaneous absorption in man.     

Persistence and Improvement of Nasolabial Fold Correction with Nonanimal-Stabilized Hyaluronic Acid 100,000 Gel Particles/mL Filler on Two Retreatment Schedules: Results up to 18 Months on Two Retreatment Schedules

BACKGROUND Nonanimal-stabilized hyaluronic acid (NASHA) fillers are frequently used for facial soft tissue augmentation. Their long-term efficacy and the effects of different retreatment schedules are not well established.
OBJECTIVE This is an 18-month interim analysis of a 30-month study to evaluate the efficacy and persistence of NASHA 100,000 gel particles/mL filler with two different retreatment schedules.
METHODS This multicenter, randomized, evaluator-blinded study enrolled 75 patients with moderate to severe nasolabial folds. Patients were randomized to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months after correction of both folds at the initial visit.
RESULTS Wrinkle Severity Rating Scale scores improved significantly ( p <.001) from baseline, with mean improvements ranging from 1.1 to 1.7 grades. Almost all patients (97%) responded satisfactorily, and the efficacy of the retreatment schedules did not differ significantly. Adverse events, primarily swelling and bruising, occurred in 33% of patients; none were serious.
CONCLUSION The improvements seen after initial treatment with NASHA 100,000 gel particles/mL filler persisted for up to 18 months with one retreatment. The response was equivalent for retreatment at 4.5 and 9 months.     

Minimizing Adverse Events Associated with Poly-l-lactic Acid Injection

BACKGROUND Injectable devices offer an attractive alternative to surgical cosmetic rejuvenation. Many injectable products are biocompatible but demonstrate varying levels of durability, ranging from temporary to permanent. Product duration is determined, in part, by its mode of operation. Passive fillers, such as collagen, generally add volume through mass, whereas other injectables, such as poly- l -latic acid (PLLA), rely on a foreign-body response in which endogenous collagen production by fibroblasts is thought to generate new volume.
OBJECTIVE To review the use of injectable PLLA, specifically regarding optimal injection technique that can reduce adverse events (AEs) and enhance out comes.
RESULTS PLLA has been used extensively to correct HIV-related facial lipoatrophy, with effects lasting for up to 2 years. The efficacy and safety of PLLA can be influenced by correct product reconstitution, dilution, and administration. Undesired AEs, such as papules and nodules, may result from incorrect reconstitution, uneven product distribution in the suspension, imprecise injection technique (superficial injection), or lack of posttreatment massage.
CONCLUSION Administration of PLLA with optimal techniques can help enhance treatment effect while simultaneously minimizing AES.