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Fda Committed To Studying Breast Implant Safety - Latest News


Statement from Binita Ashar, M.D., of the FDA's Center for Devices and Radiological Health on agency's commitment to studying breast implant safety

SILVER SPRING, Md., Sept. 14, 2018 /PRNewswire/ -- Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo br... read more

FDA plans meeting on breast implant safety, but disputes new study of risks

Women who believe their breast implants made them ill have been pushing the U.S. Food and Drug Administration for the last ... Nonetheless, MD Anderson called the new analysis "the largest study of lo... read more

FDA looks at breast implant safety

Women who believe their breast implants made them ill have been pushing the U.S. Food and Drug Administration for the last ... Nonetheless, MD Anderson called the new analysis “the largest study of lo... read more

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FDA disagrees, calls meeting on study showing breast implants' link to rare conditions

The Food and Drug Administration has refuted a link between silicone breast implants and higher rates of rare health conditions, found in a recent study. The agency has called ... that had been in pla... read more


Jury Still Out on Silicone Breast Implant Safety

MONDAY, Nov. 9, 2015 (HealthDay News) -- After years of study, a new analysis ... in the long debate over silicone breast implant safety. The implants came to the U.S. market in the 1960s. But in 1992 ... read more

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients

Objective: To analyze the long-term safety and efficacy outcomes of patients with breast implants. Methods: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related ... read more

Establishment Labs Receives IDE Approval from U.S. FDA to Initiate Clinical Trial of Motiva Implants®

The IDE approval enables Establishment Labs to move forward with a single arm, multi-center study ... Labs is committed to bringing enhanced safety and innovative products to the breast aesthetics and ... read more

Call for investigation into safety of breast implants

Please update me on any follow-up information on those symptoms for the following eight years of the study. While there are numerous breast implant ... a lack of commitment to these studies by both co... read more

FDA under fire for breast implant issues

Her experiences prompted her to become a patient safety ... implants. The FDA, which mandated the original data collection, later criticized the study, citing “inconsistencies in the data.” Last year, ... read more

US FDA approves Mentor MemoryShape breast implants

The US Food and Drug Administration ... Mentor MemoryShape (CPG Core) Breast Implant Core Study consists of 955 patients who undergo post-surgery follow up annually for 10 years. This study is designe... read more

Silicone breast implants linked to increased risk of some rare harms

This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them." Based on an FDA-mandated "postapproval" dat... read more

Rare cancer reignites debate over breast implants' safety

That question remains unsettled, because no study has ever followed enough women for enough years to tease out the risks of rare diseases. That's why the FDA imposed a big condition when it approved s... read more



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