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Ethics of Product Failure and the Courts
Published in Howard Winet, Ethics for Bioengineering Scientists, 2021
Breast implants are neither life-saving nor morbidity-reducing devices. Their need is mainly psychological, and they would be considered merely cosmetic if they were not implanted so deep subcutaneously. The shape of the female human breast appears to play an aboriginal role in sexual attraction. However, it has become so socially important to both genders that industries (e.g. fashion, lingerie, entertainment, cosmetic drugs, plastic surgery) have been created to take financial advantage of the addiction. Some women seek breast augmentation even if they have no medical condition that it would alleviate. Others have had mastectomies to save their lives from the consequences of breast cancer, and the psychological devastation from both the disease and loss of an anatomical symbol of their identity, makes recreation of the original shape a mental health necessity for them.
The person
Published in Suzanne Everett, Handbook of Contraception and Sexual Health, 2020
Trans women can have a vaginoplasty which is the creation of a vagina and vulva which includes mons pubis, labia, clitoris and urethra. Trans women can be catheterised the same as other women. Trans women who have a vaginoplasty are required to dilate their vaginas regularly. It is suggested that this be three times a day for eight weeks and then twice daily afterwards (RCN, 2016c), eventually reducing to once a week, but this will need to be continued throughout life (RCN, 2016c). Trans women will be taught how to do this. Some trans women will undergo labiaplasty rather than a vaginoplasty which is the creation of a labia, but no vagina will be created. To create breast trans women may have breast augmentation surgery.
Biological reactions to reconstructive materials
Published in Steven J. Kronowitz, John R. Benson, Maurizio B. Nava, Oncoplastic and Reconstructive Management of the Breast, 2020
Steven J. Kronowitz, John R. Benson, Maurizio B. Nava
Approximately 1.5 million prostheses are implanted annually worldwide for breast augmentation and reconstructive indications.1 In 2011, and updated in 2016, the United States Food and Drug Administration (FDA) released a safety communication stating, “Women with breast implants may have a very small but increased risk of developing anaplastic large cell lymphoma (ALCL) in the scar capsule adjacent to an implant.”2 This warning was based upon case reports dating back to a seminal case described by Keech and Creech in 1997.3 Breast implant-associated anaplastic large cell lymphoma (BI-ALCL) is a rare malignancy arising in an effusion or scar capsule surrounding a breast prosthesis.4 There are 118 individual case reports and nearly 200 pathologically confirmed cases to date, although the incidence, etiology, and predisposing risk factors have not been fully established.5
Histopathological evaluation of the effect of hyperbaric oxygen therapy on capsule occurrence around silicone breast prosthesis: an experimental study
Published in Journal of Plastic Surgery and Hand Surgery, 2021
Serhat Yarar, Abdullah Arslan, Bilsev Ince, Mehmet Emin Cem Yildirim, Pembe Oltulu, Ilker Uyar, Mehmet Dadaci
Silicone breast prostheses are being used more commonly in breast reconstruction after breast augmentation or mastectomy. In general, capsular contracture is the underlying cause of complications such as pain, stiffening, breast asymmetry, and animation deformity that are seen in the late postoperative period because of the use of silicone breast prostheses [1]. It is a known fact that after foreign bodies are inserted into the body, capsule reaction occurs around them over time. There are many mechanisms and theories in the literature which were revealed about the process of capsule reaction. The most common theory of capsular reaction is a foreign body reaction which is a natural tissue response. Macrophages, T cells, and a variety of cytokines accumulate around a foreign body (implant) as an immune response. Then, the number of proinflammatory cells decreases, and the number of fibroblasts increases around the implant. Thus, a fibrous capsule occurs [2].
Facial Feminization Surgery: The Ethics of Gatekeeping in Transgender Health
Published in The American Journal of Bioethics, 2018
There are many examples of when evidence regarding the impact of a given procedure on quality of life has led to changes in insurance coverage and reclassification of a procedure from “cosmetic” to “necessary.” Breast augmentation is considered a cosmetic procedure and not covered by insurance, but reconstructive breast surgery for cancer patients who have undergone mastectomies is considered medically necessary and therefore a covered service. Similarly, we no longer consider facial surgery for victims of extensive burns to be “cosmetic.” So too should FFS no longer be considered “cosmetic” but medically necessary and universally covered by insurance plans. Considering this important procedure as purely “cosmetic” is a failure to understand why FFS is felt to be an absolute necessity and to act on the significant improvements we have made in understanding the impact of gender dysphoria over the past few decades.
The effects of human amniotic membrane on silicone related capsule formation in rats
Published in Journal of Plastic Surgery and Hand Surgery, 2020
Mustafa Akyürek, Erkan Orhan, Mehmet Şerif Aydın, Ömer Uysal, Semra Karşıdağ
Silicone breast implants are commonly used materials in plastic surgery for breast augmentation and reconstruction [1]. Although complications such as hemorrhage, pain, hematoma, infection, numbness, implant escape, and implant rupture can be observed after implantation of the breast implant, the most severe complication is capsule contraction which occurs in 40% of patients [2,3]. In capsule contraction, an extremely hardened, fibrotic, contracted capsule is formed around the implant, and this capsule causes complaints such as pain, stiffness, and breast distortion in the patient [4,5]. The exact cause of capsule contraction is not known and is thought to be caused by multifactorial effects [3,4,6].