Transvaginal Mesh Study Concludes
The Food and Drug Administration (“FDA”) recently released results of a post-market surveillance study on vaginal mesh devices. The devices are manufactured by Coloplast and used to treat pelvic organ prolapse. The devices at issue were discontinued years ago after numerous reports of negative outcomes. But the FDA required the manufacturer, Coloplast, to complete a study already underway at the time the products were discontinued. The FDA determined again the devices carry additional risks compared to other methods of treating pelvic organ prolapse. It maintained that the benefits of the product do not outweigh the risks. The results can be found here: FDA’s Activities: Urogynecologic Surgical Mesh | FDA
Adderall Shortage in the U.S.
Adderall is a prescription drug used to treat ADHD (attention deficit hyperactivity disorder). The FDA has declared a nationwide shortage on the drug because of manufacturing delays. Nine companies manufacture Adderall and most is manufactured by Teva. Patients are advised to work with their health care provider to discuss lowering their dosage or obtaining another version of the medication. Read the FDA’s announcement on the shortage here: FDA Announces Shortage of Adderall | FDA
Consumer Update on February 2022 Recall of Abbott Baby Formula
The FDA issued a Consumer Update regarding the risk of Cronobacter sakazakii in infant formula. It is a follow up to a recall earlier this year of certain powder baby formulas manufactured by Abbott. The formulas contained Cronobacter sakazakii which can lead to serious illness. The recalled products were manufactured at Abbott’s facility in Sturgis, Michigan and include Similac, Alimentum and Elecare. The Update is meant to help consumers understand and minimize the risks. Read the Consumer Update here: What to Know About the Risk of Cronobacter in Powdered Infant Formula | FDA
More Abbott Baby Formula Recalled
Baby formula manufacturer, Abbott, has recalled a small number of lots of its Ready-to Feed liquid products. The formula was recalled because bottle caps may not have sealed completely and may spoil. This could lead to gastrointestinal problems. The products were manufactured at Abbott’s manufacturing facility in Columbus, Ohio. Detailed information can be found here: Abbott Voluntarily Recalls Certain Lots of 2 Fl. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Infant Formula Supply | FDA