Search results
Results from the WOW.Com Content Network
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.
Composed of an isotactic crystalline stereoisomer of polypropylene, Prolene sutures are intended to be durable and long lasting. They are dyed blue, allowing for easy visibility against skin and when operating. It is composed of a single filament. A polypropylene mesh Prolene product is used for repairing hernias and other injuries to the fascia.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
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.
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. The other sections are as follows:
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.
On 3 January 2012, the FDA ordered 35 manufacturers of these mesh products to study the side effects of these devices. Due to the outbreak of the COVID-19 pandemic in 2020, the demand for PP has increased significantly because it is a vital raw material for producing meltblown fabric, which is in turn the raw material for producing facial masks.
The recalls came in response to reports of renal failure in pets consuming mostly wet pet foods made with wheat gluten from a single Chinese company, beginning in February 2007. The recall began voluntarily with the Canadian company Menu Foods on March 16, 2007, when a company test showed sickness and death in some of the test animals. Overall ...