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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.
In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply. If the firm does not recall the product, then FDA can seek legal action under the FD&C Act. These include seizure of available product, and/or injunction of the firm, including a court request ...
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.
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 ...
Due to the above-mentioned propensity for polypropylene mesh to erode the tissue surrounding it, the FDA has issued several warnings on the use of polypropylene mesh medical kits for certain applications in pelvic organ prolapse, specifically when introduced in close proximity to the vaginal wall due to a continued increase in number of mesh ...
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 ...
Federal regulators have elevated a recall involving 27,600 bags of wild rice from a Northern California farm distributed to seven states due to concerns that the product may contain a foreign ...