Article citation: ¿refinements in the techniques of 2-stage breast reconstruction,¿ matthew d.Freeman, bs, rahul vemula, md, rahul rao, ma, tim s.Matatov, md, amy l.Strong, phd, mph, ravi tandon, md, abigail e.Chaffin, md, and david a.Jansen, md, facs, annals of plastic surgery, vol.76, supplement 4, june 2016, pp.S304-s311.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the senior author, dr.(b)(6), regarding the number of allergan devices used in the study, the causality of the reported adverse events, product information, date of explant surgery, name of explant surgeon, and if the explanted devices will be returned was requested.No additional information will be provided as further follow up is not possible as the doctor is unavailable for additional questioning.Device labeling: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Active infection anywhere in the body may increase risk of periprosthetic infection.Do not expose the tissue expander or injection needles to contaminants, which increase the risk of infection.Patients who present wound dehiscence, tissue erosion, ischemia or necrosis run an increased risk of periprosthetic infection.Measures to protect such areas from infection should be taken.Signs of acute infection reported in association with tissue expanders include, tenderness, fluid accumulation, pain and fever.Infection may compromise the expansion process.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature tissue expander removal.Pre-existing infections not resolved before tissue expander placement may increase the risk of periprosthetic infection.Infection is an inherent risk following any type of invasive surgery, and may occur during the tissue expansion process.Patients who present with wound dehiscence, tissue erosion, ischemia or necrosis, and patients undergoing immediate breast reconstruction run an increased risk of periprosthetic infection.Signs of acute infection reported in association with tissue expanders include erythema, tenderness, fluid accumulation, pain and fever.Erythema may also occur as a normal response to expansion.Aspiration to differentiate between this type of erythema and erythema as a sign of early infection is a recognized precaution.Research identifies staphylococcus and pseudomonas organisms in association with infection around tissue expanders.Escherichia and streptococcus organisms have also been noted in association with tissue expanders in the lower extremities.Infection may occur at any time after surgery, and may compromise the expansion process.Capsular contracture may be related to infection in the area surrounding the implant.Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications.Infection that is unresponsive to treatment or necrotizing infection may require premature breast tissue expander removal.In rare instances, acute infection may occur in a breast with implants.The signs of acute infection include erythema, tenderness, fluid accumulation, pain, and fever.Very rarely, toxic shock syndrome, a potentially life- threatening condition, has been reported in women after breast implant surgery.It is characterized by symptoms that occur suddenly and include high fever (102°f, 38.8°c or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should be advised to contact a physician immediately for diagnosis and treatment for any of these symptoms.
|