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FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

In In The News by Barbara Jacoby

From: fda.go Today, the U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants …

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Contrast-Enhanced Mammography Useful in Women with Breast Implants

In Clinical Studies News by Barbara Jacoby

By: Whitney J. Palmer From: diagnosticimaging.com CEM performance showed no significant difference between women with or without breast implants, and it produced very few complications. Contrast-enhanced mammography (CEM) is an acceptable alternative to breast MRI for women who have breast implants, according to recently presented research. CEM has already been shown to be an effective diagnostic or screening option for …

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FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma

In In The News by Barbara Jacoby

Source: fda.gov Aug. 20, 2020 Agency Also Announces Qualification of a Medical Device Development Tool to Aid in the Effectiveness Assessment of Devices Used in Breast Reconstruction Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs …

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Breast implant maker tries new push to find patients one year after cancer related recall

In In The News by Barbara Jacoby

By: JOCE STERMAN and ALEX BRAUER, Sinclair Broadcast Group From: wjla.com One year after voluntarily recalling textured breast implants shown to have a potential link to cancer, Allergan is making a new push to track down thousands of women who may not be aware of the risk. For years, Raylene Hollrah has been sounding the alarm about a rare type …

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3D-Printed Breast Implants Could Be the Next Big Thing in Plastic Surgery

In Clinical Studies News by Barbara Jacoby

By: Amanda Pedersen From: mddionline.com First-in-human clinical trials of 3D-printed resorbable breast scaffolds are expected to begin soon in Germany Two German companies have paired up on the development of a technology that could disrupt the breast implant market. BellaSeno will use Evonik’s Resomer bioresorbable polymer in its Senella breast scaffolds with a proprietary additive manufacturing process that avoids the …