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Question: A company has developed a new pelvic mesh medical device to treat Pelvic Organ Prolapse in women between the ages of 30 and 70. You are asked to set-up the Risk Assessment and Risk Reduction processes for this device. a) List eight potential adverse effects which can occur after the implantation of pelvic mesh implants. [4 marks]
a) Eight potential adverse effects after the implantation of pelvic mesh implants: 1. Mesh erosion: The mesh may erode through the vaginal wall or surrounding tissue, potentially causing pain, discharge, and further complications. 2. Infection: Surgical site infection can occur, leading to an increased risk of additional surgeries and further complications. 3. Pain: Women may experience both acute and chronic pain following the implantation, affecting their quality of life and daily activities. 4. Bleeding: Excessive bleeding during or after the surgery may occur, requiring additional treatment or intervention. 5. Organ perforation: The mesh may inadvertently puncture nearby organs, such as the bladder or bowel, leading to serious complications like urine leakage or bowel obstruction. 6. Urinary problems: Urinary incontinence, urgency, or difficulty emptying the bladder can result from the surgery or the implant itself. 7. Sexual dysfunction: Women may experience pain during sexual intercourse or a decrease in sexual function after mesh implantation. 8. Recurrence of pelvic organ prolapse: The initial issue of pelvic organ prolapse may recur, despite the implantation of the mesh, necessitating further treatment or intervention.
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