FDA Warns Doctors to Look Out for Rare Cancer Linked to Breast Implants

(WASHINGTON) — U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease. The Food and Drug Administration sent a letter late Wednesday to family doctors, nurses and other health professionals warning about the form of lymphoma in breast implant patients. In suspected cases, the FDA recommends laboratory testing to confirm or rule out of the disease. It’s the first time regulators have issued such a warning to doctors other than plastic surgeons. The disease is not breast cancer, but usually forms in the scar tissue that forms around implants. Regulators said they have identified 450 likely cases of the cancer since 2010. That’s a tiny number considering 400,000 U.S. women receive implants annually.
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Cancer onetime Source Type: news

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A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to. The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Oncology Women's Health Source Type: news
The FDS has warned pharmaceutical companies in the past about their use of paid surrogates on social media sites like Instagram to promote their products (see:Pharmaceutical Companies Continue to Experiment with Social Media;FDA Issues Warning Letter to Drug Company about Use of Instagram;GlaxoSmithKline Mines Social Media for Information about Adverse Drug Events). This issue has recently returned to the news (see:The latest Instagram influencer frontier? Medical promotions. Big pharma is partnering with influencers to sell new drugs and medical devices). Below is an excerpt from the article. It's long and provides ma...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Source Type: blogs
Breast implants are causing more deadly breast cancer among women, according to the U.S. Food and Drug Administration.
Source: Health News - UPI.com - Category: Consumer Health News Source Type: news
Conclusions: In situ BIA-ALCLs have an indolent clinical course and remain in complete remission mainly after implant removal. Infiltrative BIA-ALCLs have a more aggressive clinical course. It is therefore critical to perform a rigorous staging using multi-imaging modality including TEP at baseline. Multiple implants could favor the occurrence of BIA-ALCL. New insights into the biology of BIA-ALCL might translate into more targeted and effective therapies in refractory or relapsed patients. The modalities of breast monitoring and reconstruction remain open questions for those patients.DisclosuresLe Bras: Amgen: Consultancy...
Source: Blood - Category: Hematology Authors: Tags: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster I Source Type: research
CONCLUSION: The risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is estimated at 0.35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, yet nevertheless markedly higher than that of other primary lymphomas of the breast. Because of the low case numbers, recommendations for the diagnostic evaluation and treatment of this entity have not been adequately evaluated. Treatment with primary curative intent for BIA-ALCL confers a much better prognosis than when performed for a systemic ALCL. Whenever a patient with a breast implant presen...
Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
By Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of decisions should be discussed between a patient and their provider in a transparent and balanced way with clear information about the benefits and risks of the breast implants and the procedure. As a public health agency, we play an important role in ensuring that patients ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news
CONCLUSION: In the literature, some articles describe correlation between connective tissue diseases and silicone breast implants, but the pathogenetic mechanisms are unknown. We report a rare case of breast morphea after positioning a silicone implant in a patient who had undergone mastectomy. This clinical report represents an interesting model of multidisciplinary management of a patient with breast cancer who developed an uncommon dermatologic disease. Further studies are needed to clarify the association between silicone implants and breast morphea. PMID: 29714655 [PubMed - as supplied by publisher]
Source: Tumori - Category: Cancer & Oncology Tags: Tumori Source Type: research
Women with breast implants have an increased risk of a type of lymphoma that can usually be cured by surgery alone — but not always.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Implants Breasts Allergan Inc Breast Cancer Non-Hodgkin's Lymphoma Mentor Worldwide LLC Food and Drug Administration American Society for Aesthetic Plastic Surgery Source Type: news
A rare cancer of the immune system, linked to implants, has had devastating effects on women, many of whom had reconstructive surgery after breast cancer.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Implants Allergan Inc Immune System Surgery and Surgeons Cancer Non-Hodgkin's Lymphoma Breasts Plastic Surgery Source Type: news
ByChristine A. Hamori, MDRecent media coverage of an FDA update regarding BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma) is causing a lot of concern among breast implant patients. First of all, patients should know that BIA-ALCL is not new, and that this is a very rare disease. Also, it is only associated with textured implants. During every breast augmentation consult I do with every potential patient, we go over this information. In fact, rarely do my patients and I choose a textured implant.My colleague Dr. William Adams has published this informative update with a video from the Plastic Surgery Cha...
Source: What's New In Plastic Surgery? - Category: Cosmetic Surgery Tags: bia-alcl breast cancer breast implant associated anaplastic large cell lymphoma breast implants fda Source Type: blogs
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