Murphy DK

[BACKGROUND] Women with breast implants may have concerns about their ability to successfully breast-feed. The Breast Implant Follow-up Study (BIFS-001) is a large, 10-year observational study evaluating the performance and safety of Natrel…

[BACKGROUND] Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. [OBJECTIVE] To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate …

[BACKGROUND] VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. [OBJECTIVE] To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized …

[BACKGROUND] Natrelle 410 silicone breast implants are approved in the United States for breast augmentation, reconstruction, and revision. [METHODS] In two ongoing, prospective, multicenter 10-year studies, 17,656 subjects received Natrel…

[BACKGROUND] The hyaluronic acid (HA) dermal filler, Juvéderm® Ultra, which employs Hylacross® technology, produces a gel with a smooth consistency and has demonstrated effectiveness in correcting nasolabial folds (NLFs) in Caucasian popula…

[BACKGROUND] A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. [OBJECTIVE] To describe the development and validation of the 5-poi…

[BACKGROUND] Natrelle 410 implants (Allergan, Inc., Irvine, CA) are approved in the United States for breast augmentation, reconstruction, and revision. [OBJECTIVES] To assess the risk of nipple and skin sensation changes and lactation iss…

[BACKGROUND] The Breast Implant Follow-up Study is a large, ongoing observational study of women who received Natrelle round silicone-filled or saline-filled breast implants. This analysis describes patient-reported outcomes in the cohort w…

[BACKGROUND] The safety and effectiveness of the Natrelle Style 410 highly cohesive silicone gel breast implant (Allergan, Inc., Irvine, Calif.) in full or moderate height and projection have been shown in a 10-year study. Extra-full projec…

[BACKGROUND] Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler. [METHODS] In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidoc…

[BACKGROUND] Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD). [OBJECTIVES] The effectiveness of Juvéderm Voluma XC was examined from the patient perspective. [METHO…

[BACKGROUND] Juvéderm Voluma XC (VYC-20L) is approved in the United States for correction of age-related volume loss in the midface region in adults. [OBJECTIVE] To characterize the effects of VYC-20L in 3 midface subregions based on injec…

[BACKGROUND] Juvéderm Voluma XC (VYC-20L; hyaluronic acid gel) is approved in the United States for correction of age-related midface volume deficit (MVD). [OBJECTIVE] Assess safety and effectiveness of VYC-20L after repeat treatment. [ME…

[BACKGROUND] Hyaluronic acid gels are increasingly used for augmentation of the lips. [OBJECTIVE] To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for …

[BACKGROUND] Juvéderm® Volbella® with Lidocaine is a hyaluronic acid filler suited for lip enhancement. [OBJECTIVE] Evaluate the safety and effectiveness of Juvéderm Volbella with Lidocaine versus non-animal stabilized hyaluronic acid with…

[BACKGROUND] Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome…

[BACKGROUND] Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. [METHODS] Se…

[BACKGROUND] Hyaluronic acid (HA) gels are commonly used to correct age-related midface volume deficit (MVD), yet the Food and Drug Administration has not specifically approved them for this purpose. [OBJECTIVE] To study the safety and eff…

[BACKGROUND] The Natrelle Style 410 shaped, form-stable silicone gel implant (Allergan, Inc; Irvine, California) has been the subject of a pivotal study that supports potential US Food and Drug Administration approval of the device. The 3-y…

[BACKGROUND] Hyaluronic acid dermal fillers are frequently used for lip augmentation, and a new filler has been developed with characteristics especially suited for the lips. [METHODS] Four European sites treated 60 subjects with Juvéderm(…

[BACKGROUND] In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously publish…

[OBJECTIVES] To assess the safety and effectiveness of hyaluronic acid (HA) fillers in skin of color. [METHODS] Two prospective studies followed up subjects with Fitzpatrick skin phototypes of IV, V, or VI for 24 weeks after dermal filler …

[INTRODUCTION] Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm((R)) injectable gel with lidocaine (denoted as JUV + L) to commercially-avai…

[BACKGROUND] Natrelle saline-filled breast implants (Allergan, Santa Barbara, CA) are in widespread use in the United States for both breast augmentation and reconstruction. The primary safety concerns are local complications and secondary …

Psychosocial outcomes are believed to be a critical factor in determining the success of cosmetic surgery, but little research has focused on measuring these factors in breast augmentation patients. In the multicenter study for FDA approval…

[BACKGROUND] With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with g…

[BACKGROUND] Silicone gel-filled breast implants were developed in 1962 but did not fall under the auspices of the U.S. Food and Drug Administration until 1976 and were not classified as class III devices until 1988. This set the stage for …

[BACKGROUND] In February of 2001, Allergan (formerly Inamed) began an Investigational Device Exemption study of a shaped breast implant: the Style 410 highly cohesive silicone-filled breast implant. [METHODS] Forty-eight plastic surgeons a…

[BACKGROUND] A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a…

Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort…