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Cosmetic procedures
Published in Melanie Latham, Jean V. McHale, The Regulation of Cosmetic Procedures, 2020
Melanie Latham, Jean V. McHale
One major issue that has also arisen in relation to the safety of cosmetic procedures is that of the use of defective products. This was of course exemplified by the PIP breast implant scandal where industrial rather than medical grade silicone was used in the production of the implants.58 In this section we look at the measures currently in place for regulating the safety of such products and the question of accountability where harm is caused as a result of the use of those products.
Incontinence Pessaries
Published in Teresa Tam, Matthew F. Davies, Vaginal Pessaries, 2019
Disposable incontinence devices have been developed and marketed for use in recent years for women interested in the nonsurgical management of SUI in the setting of short periods of activity. Disposable incontinence devices come in varying sizes, and depending on the brand, sizing can be performed by the patient at home using a sizing kit or in the office similar to traditional incontinence pessaries. The Impressa bladder support device (Figure 3.6) is an FDA-approved over-the-counter disposable incontinence device marketed for up to 12 hours of use within a 24-hour period for the temporary management of SUI in women. This particular disposable incontinence device offers a sizing kit for at-home self-fitting and comes in three distinct sizes marketed for “low,” “medium,” and “high” levels of support. The sizing kit comes with two bladder supports of each size and has a retail value of $4.99, while single-size packs of 10 devices retail at $14.49 per package. The device is inserted into the vagina using a plastic applicator similar to that of a menstrual tampon, with a polyester and rayon string at the distal end that protrudes out of the vagina for self-removal. The device is constructed from medical-grade silicone and surrounded by a nonabsorbent polypropylene covering.
Aesthetic
Published in Tor Wo Chiu, Stone’s Plastic Surgery Facts, 2018
PDMS silicone oil is FDA approved for HIV retinopathy, creating a source of medical-grade silicone that is often used off label. Silicone oil has been used extensively for augmentation but is associated with significant complications.
Paclitaxel-eluting silicone airway stent for preventing granulation tissue growth and lung cancer relapse in central airway pathologies
Published in Expert Opinion on Drug Delivery, 2020
Jesse Xu, Hui Xin Ong, Daniela Traini, Jonathan Williamson, Michael Byrom, Larissa Gomes Dos Reis, Paul M. Young
Current biocompatible medical grade silicone stents are constructed and shaped via injection molding of a siloxane elastomer or polydimethylsiloxane-based LSR prior to curing [9]. Stents are mainly available as standardized off-the-shelf, one-shape-fits-all geometries. As a result, poorly fitted stents increase the risk of stent migration [10] and contribute to granulation tissue growth following inconsistent pressure and mechanical trauma applied onto airways [11]. Measures to resolve problems from poorly fitting airway stents include research and development of personalized airway stents based on 3D analysis of individual airway geometries and 3D-printing techniques. To achieve this, there has been steps toward making 3D-printed molds to allow for silicone to be cured in unique patient geometries [12].
Genital vibration for sexual function and enhancement: best practice recommendations for choosing and safely using a vibrator
Published in Sexual and Relationship Therapy, 2018
Jordan E. Rullo, Tierney Lorenz, Matthew J. Ziegelmann, Laura Meihofer, Debra Herbenick, Stephanie S. Faubion
Vibrators are made from many different materials including silicone, hard plastic, glass, stainless steel, wood, rubber, vinyl/cyberskin, jelly rubber and other varied thermoplastic elastomers not listed. Many companies that sell vibrators describe them as for “novelty use only”, presumably to bypass FDA regulation. Some unregulated vibrators made of jelly rubber have been found to contain phthalates, a potential human carcinogen. Several types of phthalates, including those used in vibrators, have been banned from use in children's toys by the United States Congress (Stabile, 2013). However, after extensive study of phthalates in sex devices, the Danish Environmental Protection Agency concluded that they are safe to use for up to 1 hour per day. Even so, they warned that for women who are breastfeeding or pregnant, use should be limited to 15 minutes per week due to the potential for minor developmental effects on the fetus (Nilsson, Malmgren-Hansen, Bernth, Pedersen, & Pommer, 2006). Given the concerns mentioned above, it is reasonable to counsel patients to use vibrators made of nontoxic material, such as silicone, hard plastic, glass and stainless steel (Herbenick, 2010). As some vibrators described as “silicone” are likely mixed with other materials, consumers who prefer a vibrator made of silicone might choose one described as using “medical grade silicone” or might choose to purchase from a well-established manufacturer that is forthcoming about the materials used.
Intranasal drug delivery devices and interventions associated with post-operative endoscopic sinus surgery
Published in Pharmaceutical Development and Technology, 2018
Lari K. Dkhar, Jim Bartley, David White, Ali Seyfoddin
The intranasal splint supports the nasal septum and minimizes the adhesion risk between septum and lateral nasal wall following ESS. These are made of soft and flexible medical grade silicone. The use of intranasal splints has increased due to their ability to keep the operated septum in the midline preventing epistaxis and nasal synechiae (Deniz et al. 2014). They also reduce haemostasis after surgery (Yi et al. 2014). Nasal splinting can be an alternative to other non-absorbable packing but trans-septal suturing of the splints is challenging and time consuming (Asaka et al. 2012). The existing evidence for these devices in the literature is contradictory. Some previous studies preferred biodegradable packings while others stated an equal outcome to non-absorbable packings/no packing (Wang et al. 2014). In addition, the cost-effectiveness of the biodegradable material currently used in this splint also remains controversial (Wang et al. 2014).