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Prolene is a brand of synthetic polypropylene used in monofilament nonabsorbable sutures and meshes. The suture is indicated for skin closure and general soft tissue approximation and ligation. Its advantages include minimal tissue reactivity and durability.
Surgical mesh is implanted to strengthen tissue repair and minimize the rate of recurrence. The surgery can be performed laparoscopic (internally) or open with a variety of materials available for prosthesis. [4] Polypropylene (PP) is the most frequently used type of mesh, although it may be uncomfortable for the patient after implantation.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Polypropylene is most commonly used for plastic moldings, wherein it is injected into a mold while molten, forming complex shapes at relatively low cost and high volume; examples include bottle tops, bottles, and fittings. It can also be produced in sheet form, widely used for the production of stationery folders, packaging, and storage boxes.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
Earlier this year, Dutch medical device maker Royal Philips reached a $1.1 billion deal to settle thousands of claims stemming from a recall in 2021 of millions of its breathing machines like ...
Transvaginal mesh, also known as vaginal mesh implant, is a net-like surgical tool that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) among female patients. The surgical mesh is placed transvaginally to reconstruct weakened pelvic muscle walls and to support the urethra or bladder.
Recall bias is of particular concern in retrospective studies that use a case-control design to investigate the etiology of a disease or psychiatric condition. [ 3 ] [ 4 ] [ 5 ] For example, in studies of risk factors for breast cancer , women who have had the disease may search their memories more thoroughly than members of the unaffected ...