The mechanism of gel sheeting may be warmth, hydration, or occlusion. 28.20). An article about the dangerous side effects of liquid silicone in today's New York Times provides yet another reason for women to ditch plastic surgery and embrace their age. You may report side effects to FDA at 1-800-FDA-1088. 1. Allergan (former Inamed) Corporation developed the BioDimensional®Planning System in which a matrix of 12 possible combinations of implant height and projection are available for the specific needs of the individual patient. We believe the intact Heyer-Schulte explant with 22 years of implantation (Fig. Side effects. Our aim was to assess the effect of topical application of silicone gel compared with placebo on SD using non-invasive devices and by immunohistochemical analysis of sequential tissue biopsies in a double-blind controlled trial. As with all other treatments, the keloid scar takes longer and gets less overall improvement. Three patients had significant problems with deforming granulomas after implant rupture [42]. For the Simaplast and McGhan shells, the low percentages of material extracted (2.8%, 2.7% and 3.1%) indicate a higher percentage of monomer was incorporated into the elastomer. Some of the products that use the packets include leather shoes, food, electronics and medications. Recedo (Medical-grade Topical Silicone, Topical Gel) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. Evans14 advocates scar management using micropore paper tape applied longitudinally along the incision line once epithelialization has occurred. Even so, the Simaplast implant remained intact for 23 years. This therapy has been studied for both treatment and prophylaxis of excessive scarring. I pushed through with 15ml 3 times a day for a week but still no improvement unfortunately. There are several additional important findings noted with silicone gel sheeting treatment of scars: the younger patients, under age 18, have much faster and more responsive results than do adults; the silicone gel sheeting is effective in prevention of both hypertrophic and keloid scarring in known scar formers; compression with the silicone gel sheeting is not necessary for good results; later recurrence of scarring does not occur; and most sensitive and tender scars will return to near-normal sensation after being treated with silicone gel sheeting for at least 1 month (Fig. Recedo(Medical-grade Topical Silicone, Topical Gel) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. Reprinted with permission from ref. Life Stories. However, as long as the silica gel does not contain cobalt chloride, it is actually not … The gel sheeting should be worn 23 hours per day for 1 year but may need to be discontinued due to skin breakdown. Pressure therapy is a long-term treatment, so most patients become less compliant after several months. Furthermore, the fourth-generation devices were manufactured with improved quality control. Silica gel packs, used in the packaging process of many products to keep out moisture, come with warning labels. Silicone gel breast prostheses are associated with a mild foreign body response resulting in the formation of a collagenous capsule around the prosthesis [37,38]. Intact Heyer-Schulte saline explant with 22 years of implantation. From: Biomaterials in Plastic Surgery, 2012, Allison Nauta, ... H. Peter Lorenz, in Principles of Regenerative Medicine (Second Edition), 2011. Tensile strength and elongation of extracted saline explant shells. Silicone gel sheeting generally does not work well on mature keloids. A major reason for analyzing explants with the types of tools described in our protocol is to determine the effect(s) of implantation on shell properties. 2  You can recognize silica containing cobalt chloride because it … Conse¬quently, they were classified only by manufacturer and implantation duration and analyzed accordingly. Table 7.6. During centrifugation, while the cell-clot coagulum settles to the bottom of the tube, the gel viscosity decreases, and the gel migrates to the surface of the clot. The safety of silicone gel-filled breast implants has been studied more rigorously and extensively than any other medical device in the medical literature. The mechanism of action is not completely understood. By keeping out moisture, this desiccant helps prevent mold, mildew and corrosion. 7.21. Table 7.8. Each 100ml of Silicic acid gel contains 3.5g Silicon dioxide. The former Inamed Corporation developed a multi-layer implant shell in which a patented barrier-coat material is sandwiched between two layers of silicone elastomer (Intra-shiel®). Similarly to gel sheets, they lack proven efficacy but likely reduce scar erythema. G.P. Tell your doctor all medications and supplements you use. Maxwell, A. Gabriel, in Biomaterials in Plastic Surgery, 2012. The separators are generally best used at 20–25 °C because chilling may impair the flow characteristics and too high a temperature may cause breakdown of the gels as well as vitiation of the serum components. A. Agarwal, ... N.L. By varying the −Si−O− chain lengths, side groups, and crosslinking, silicones can be synthesized with a wide variety of properties and compositions. The tensile strength and tear resistance of the Simaplast explant are much higher than that of the other four explants, but its percentage elongation is the lowest. Similarly to gel sheets, they lack proven efficacy but likely reduce scar erythema. Twenty volunteers massaged silicone and placebo gels into separate sides of the abdomen, daily for 6 weeks. In France, 30 000 women had had PIP implants and in a retrospective study of 1150 PIP breast implants in 630 patients the rate of rupture was 7.7% (64/828), corresponding to 12% of patients. A periprosthetic effusion was associated with rupture in 44% of cases. drugs a-z list Unfortunately, these early devices had a relatively high contracture rate that encouraged implant manufacturers to develop second-generation silicone gel-filled implants. The development of these fifth-generation devices has resulted from advances in the technology of silicone gel. Silicone gel sheeting is safe and effective treatment for hypertrophic and keloid scars. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. The large amount of material extracted from the Heyer-Schulte shells is comparable to the percent extracted from many silicone gel implant shells, which contain silicone molecules from the gel filler. Whilst scar tissue will never return to 'normal', and it is important that expectations are realistic, many who try this option have been very happy with the results. Silicone gel-containing breast implants are known to leak small amounts and can on occasion rupture, causing an intense inflammatory reaction largely composed of histiocytes (Fig. Complications and side-effects of scar treatment with topical silicone sheeting are relatively few and very minor or transient in nature. CYNTHIA COOPER, in Fundamentals of Hand Therapy, 2007. This is not a complete list of side effects and others may occur. With no controls available for these explants, any assessment of the effects of in vivo aging is limited because the values of the shell properties at implantation are unknown. These silicone gel breast implants were designed under more stringent ASTM (American Society for Testing Methodology) and FDA-infiuenced criteria for shell thickness and gel cohesiveness. If in excessive of the RDA amounts, toxicity arises but stay on the safe side and avoid use. Young, in Biomaterials in Plastic Surgery, 2012. G. Dock Dockery, in Lower Extremity Soft Tissue & Cutaneous Plastic Surgery (Second Edition), 2012. These anatomically shaped (Style 410) implants are available only to investigators in the United States, with a range of volumes and any of the twelve combinations of low, moderate, and full height with low, moderate, full and extra projection. In published studies, patients show improvement of hypertrophic scars with use of silicone sheeting 80% to 100% of the time; however, silicone sheeting alone is successful in treating keloids only 35% of the time. With the evolution of the fifth-generation silicone gel implants, the concept of anatomically shaped implants was carried to the next level. Silicone maintains contact with the wound without causing friction and shear, thereby reducing tear force on removal. However, silicone gel sheets will likely continue to be used as a non-invasive treatment with few adverse effects. If consumed in large quantities, silica gel has been said to cause stomach upset. Recommended minimum treatment time is 60–90 days. If side effects are experienced, see a doctor or qualified healthcare practitioner. Ingesting silica gel causes dehydration and discomfort since the main purpose of the product is to absorb water, but only if a lot is swallowed. Recedo may interact with other drugs. Most published implant properties data relate to silicone gel devices. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Principles of Regenerative Medicine (Second Edition), Quinn, 1987; Ahn et al., 1991; Carney et al., 1994, Meyler's Side Effects of Drugs (Sixteenth Edition), Polymeric materials for chronic wound and burn dressings, Plastic Surgery Secrets Plus (Second Edition), The safety of breast implants: epidemiologic studies, Sample Collection, Including Participant Preparation and Sample Handling, The Immunoassay Handbook (Fourth Edition), Lower Extremity Soft Tissue & Cutaneous Plastic Surgery (Second Edition), Fundamentals of Clinical Reasoning: Hand Therapy Concepts and Treatment Techniques, Retrieval and analysis of breast implants emphasizing strength, durability, and failure mechanisms, Journal of Pharmacological and Toxicological Methods. This product made my heartburn significantly worse immediately. Unless otherwise directed by your healthcare practitioner, apply Recedo Gel evenly in a thin layer twice daily. Copyright 2003 Begell House. In the 1970s, the second-generation silicone implants were developed in an effort to reduce the incidence of capsular contracture with a thinner, seamless shell and without Dacron patches incorporated into the shell. More importantly, they suffered the consequences of silicone gel migrating down the arm. The ultimate strength properties of tensile strength, elongation, and tear resistance are presented in Table 7.7 for the five as-received (nonextracted) shells. There are no known side effects with use of silicic acid. For example, silica gel beads may contain poisonous and potentially carcinogenic cobalt (II) chloride, which is added as a moisture indicator. Tell your doctor if you experience any side effects while using Recedo Gel. It also contains the preservatives: Sorbic acid (E 200), Sodium benzoate (E 211). It causes cervical and breast cancer, it irritates vaginal mucus, it causes allergies, and it leads to intestinal obstruction. 28.21). No matter what your skin type, one of the ingredients I recommend avoiding is silicone. In March, 2010, the French Health Products Safety Agency suspended the sale of prefilled silicone breast implants manufactured by Poly Implants Prosthèse Prothese (PIP) because of a high failure rate and the use of an inappropriate silicone gel that did not comply with CE marking [43]. Copyright © 2021 Elsevier B.V. or its licensors or contributors. 7.21. Ultimate strength properties of five saline explant shells. The chapter emphasizes results drawn from the most recent epidemiologic investigations and from studies with long-term follow-up, often longer than three decades, as well as those that address some of the historically widespread adverse outcome claims regarding cosmetic breast implants, including connective tissue disease, local complications, offspring health effects, implant rupture, cancer, and psychologic outcomes including suicide. Data from a failed Heyer-Schulte explant with 21 years of implantation and failed McGhan textured explants with 5.5 and 3 years in vivo are presented for comparison. Yes. These implants were round in shape (non-anatomical) and filled with a less viscous silicone gel to promote a natural feel. As with silicone gel shells, property measure¬ments of the unextracted saline shells are lower than those of the extracted shells. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. For maximum effect, Recedo Gel should have 24-hour contact with the skin. However, silicone gel sheets will likely continue to be used as a non-invasive treatment with few adverse effects. Can silicol ® gel be taken long-term? Some foam dressings (as described above) have a secondary coating of a soft silicone layer at the wound interface to reduce trauma to the wound bed and pain during dressing removal (Malone, 1987). Stephen Daane MD, Bryant A. Toth MD, in Plastic Surgery Secrets Plus (Second Edition), 2010. © Recedo Patient Information is supplied by Cerner Multum, Inc. and Recedo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. Nonsilicone gel dressings, such as polyurethane (Curad), also can lead to regression of keloids. 1. New research suggests that side effects of silicone gel breast implants may cause women to experience a variety of health problems, including melanoma, arthritis and other complications. The materials can be cyclic or polymeric. Neither lot-matched controls nor controls that would yield shell property ranges were available for the saline explants listed in Table 7.6. Side effects were minimal. We use cookies to help provide and enhance our service and tailor content and ads. This is best accomplished by comparing explants to proper controls. Inserts made of padded materials or silicone gel pads also help facilitate scar maturation.13 This padding is thought to promote neutral warmth of the area and may decrease oxygen to the collagen, thus promoting collagen maturation. Unless otherwise directed by your healthcare practitioner, apply Recedo Gel evenly in a thin layer twice daily. Dressings made of medical grade silicone gel bound to a soft and pliable polyamide net are also available (White and Morris, 2009). Scar therapies such as silicone gel sheeting allows individuals who want a non-invasive approach to regain some control over their therapy. Learn more about Silicon uses, effectiveness, possible side effects, interactions, dosage, user ratings and products that contain Silicon medical-grade topical silicone, topical gel, Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases, Recedo (Medical-grade Topical Silicone, Topical Gel). L. Lipworth, J.K. Mclaughlin, in Biomaterials in Plastic Surgery, 2012. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. There are no reported side effects of Recedo Gel. The shell of the first-generation implant was constructed using a thick, smooth silicone elastomer as a two-piece envelope with a seam along the periphery. The implant was anatomically shaped (teardrop) and had several Dacron fixation patches on the posterior aspect to help maintain the proper position of the implant. I purchased this product based upon reviews and the lack of side effects. This diffused silicone may be encountered as an oily, sticky residue surrounding the implant within the periprosthetic capsule during explantation of older silicone-filled implants. The bottle states it helps heartburn. We have recently applied our protocol to investigating several saline explants that were removed after varying implantation times.1 A brief description of the five explants tested is presented in Table 7.6. After the FDA required the temporary removal of third-generation silicone gel implants from the American market in 1992, the fourth-generation gel devices evolved for their market re-introduction. The FDA has warned that injected liquid silicone may move throughout the body and can cause serious health consequences, including death. home The hydrophobic silicone layer prevents the dressing from adhering to the wound surface. Non-adhesive soft silicone dressings are particularly useful for painful wounds, such as second degree burns, donor sites and chronic leg ulcers, and are used in pediatric patients (Morris et al., 2009, White and Morris, 2009, Zillmer et al., 2006, Cunningham, 2005).