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A price for women’s beauty: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

March 27, 2017 – We all adore the beauty of women. Some women may feel that they need some help from medical practice to become the most  beautiful. When it comes to corrective breast implants, the price may be very high in some rare cases, where women develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a very serious, sometimes even fatal adverse reaction towards the implant.

This notion follows the announcement by the American Food & Drug Administration (FDA) that it has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.

Anaplastic Large Cell Lymphoma (ALCL)

This update on information regarding BIA-ALCL is geared towards plastic surgeons, health care professionals in oncology, and patients having had or considering to have breast implants alike. It follows the 2011 evaluation of safety data where FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. FDA continues to collect and evaluate information about ALCL in women with breast implants.
The current FDA recommendations are as follows: For healthcare providers: If you have patients with breast implants, you should continue to provide them routine care and support. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended. Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers’ labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
For patients: Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. If you already have breast implants, there is no need to change your routine medical care and follow-up.
See also the complete FDA Update for additional information, including a summary of Medical Device Reports and medical literature, and recommendations for patient care. Of course, it is needless to mention that this present information may apply and is seriously important for women (patients) everywhere on the globe.
 
thassodotcom

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Posted in Adverse Drug Reaction [ADR], New Safety Information, Regulatory Announcement, Thasso Post, Theragenomic Medicine
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