UNITED STATES - June 1, 2020 - According to the FDA, the agency has issued warning letters to two U.S. breast implant manufacturers. The warning letters were issued due to the failure of the companies to comply with regulatory requirements. Allergan, based in Irvine, California, received a warning letter from the FDA concerning the … [Read more...]
FDA Issues Warning Letters to Textured Breast Implant Manufacturers
Breast Cancer Survivors Fearful of New Implant Warnings
ROCHESTER, N.Y. — Breast cancer survivors face another scare. Many breast cancer survivors who had their breast reconstructed with textured rather than smooth implants are now gravely concerned their reconstructed breast could give them cancer again. WHEC reported that medical device manufacturers who made the textured implants had … [Read more...]
FDA Implant Label Announcement Seeks Consumer Clarity
On Oct. 23, 2019 the United States Food and Drug Administration (FDA) released an announcement regarding breast implants in the U.S. according to the Washington Post. The FDA implant label announcement addressed labeling concerns for manufactures and raised awareness from physicians to try to assist patients in acknowledging the … [Read more...]
Women Worldwide Have Complaints of Breast Implant Illness
UNITED STATES – According to an online news article published by theswaddle.com, tens of thousands of women who have breast implants are complaining of “Breast Implant Illness (BII).” A recent global recall of textured breast implants manufactured by Allergan has brought to light that tens of thousands of women report symptoms … [Read more...]
Textured Gluteal Implants Linked to Cancer
People Magazine featured a story concerning the dangers of textured silicone gluteal implants. The U.S. Food and Drug Administration is currently investigating claims that textured breast implants cause anaplastic large cell lymphoma, which is a form of a rare cancer of the blood. Now, after one woman died from anaplastic large cell … [Read more...]
Hundreds of Thousands Suffer Pain from Failing Medical Implants
Most people have an idea of how new drugs are tested and approved to ensure the safety and efficacy of a new medication. Clinical trials are normally performed with stringent guidelines before a new drug is made available to the public. Medical implants, by comparison, are not required to undergo clinical trials and many of these … [Read more...]
Breast Implants and a Rare Cancer
A possible association between breast implants and anaplastic large cell lymphoma (ALCL). Since 2011, when the U.S. Food and Drug Association (FDA) identified a possible association between breast implants and anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma, the agency has worked to better understand the … [Read more...]
