There is no clear linkage at this point between the patient's implantation of mpq and her reaction, however the patient has requested a sample of the product so it can be used to either identify what she is allergic to in mpq, or rule it out.The incident is being reported due to the lack of information regarding the severity of the reaction and the likelihood it was related to mpq.We will continue to gather more information and add it as it becomes available.
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A (b)(6) year-old female patient with a history of stress incontinence, post-menopausal bleeding and urge incontinence was implanted with macroplastique (mpq) implants on (b)(6) 2017.Forty-eight hours after the implantation, the patient experienced an allergic reaction which caused stiffness in her hands that progressed to increased pain in the joints of her hands.The patient's hands became extremely red and were hot to the touch.A doctor prescribed the patient with a 3 day course of 60 mg of prednisone.Patient stated she felt better the morning after taking the prednisone.The bulking agent is still implanted in the patient.
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