FDA Issues Warning Letters to Textured Breast Implant Manufacturers
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...]
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...]
Shocking Discovery of Cancer Caused by Some Implants
Breast implants have become very popular with breast augmentations in the United States from 2000 to 2016 increasing 37 percent, and reconstructions after mastectomy rising 39 percent. Nearly 400,000 women in the U.S. get breast implants annually: 300,000 for cosmetic reasons and approximately 100,000 for reconstruction after cancer, … [Read more...]
Breast Implant ALCL Lymphoma Side Effects
Breast Implant ALCL Lymphoma Side Effects. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses. Are you a breast implant recipient whose been diagnosed with lymphoma? The U.S. Food & Drug Administration (FDA) recently warned that both silicone and saline breast implants … [Read more...]
Implant Maker Sientra Halts U.S. Sales of Breast Implants
Breast implant maker Sientra has halted U.S. sales of breast implants made by contract manufacturer Silimed, following suspension of sales in Brazil, the U.K., and other countries. Sientra, based in Santa Barbara, California, posted a letter to surgeons on its website, asking that they stop implanting the devices until further … [Read more...]
Defective French Silicone Breast Implants Maker Warned
French company that manufactured silicone breast implants. The French company that manufactured silicone breast implants now at the center of worldwide cancer panic has also had run-ins with U.S. regulators. According to a report from Reuters, the U.S. Food & Drug Administration (FDA) sent Poly Implant Prothese (PIP) a … [Read more...]
French-Made Silicone Breast Implant Scare
A Silicone Breast Implant May Cause Cancer. Fears that a recalled silicone breast implant could cause a rare form of cancer are spreading around the world. According to a report in The New York Times, regulator in at least a half dozen countries are trying to ease fears among women who have received silicone breast … [Read more...]
FUNGAL CONTAMINATION OF SALINE BREAST IMPLANTS
Fungal Contamination Were Found In Saline Breast Implants. A report in the July 1 Journal of Infectious Diseases confirms that five cases of fungal contamination were found in saline-filled breast implants following corrective surgical procedures. Investigators from the Tennessee Department of Health found that the black sediment … [Read more...]
Bristol-Myers Squibb Reaches Settlement Over Breast Implants
87 Women Had Agreed to a Confidential Breast Implants Settlement. U.S. pharmaceutical maker Bristol-Myers Squibb Co. has reached an out of court settlement with a group of Australian women over faulty breast implants manufactured by the company, a court heard Tuesday. The New South Wales state Supreme Court was told that … [Read more...]
