February 17, 2019 – The unfortunate recognition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a very rare form of a T-cell lymphoma, gains more momentum by the day. This is actually very positive a development, because it helps women who are getting breast implants for whatever reasons to better known associated health risks, some of which, such as BIA-ALCL, may turn out to be fatal for some unlucky women patients. It also alerts and rises readiness for action with regulatory authorities worldwide.
Starting around two years ago in March 2017, an update was issued by the American Food and Drug Administration (FDA), which paid new attention to the occurrence of BIA-ALCL in woman with breast implants. It is thought that BIA-ALCL may develop around a silicone gel-or saline-filled implant, with some lag time until it is detected which may be as long as about 9.2 years as judged from the today’s known and reported cases.
As of February 2019, the FDA has gotten a total of 660 reports of BIA-ALCL cases in the US since 2010 with around 246 new reports of BIA-ALCL in the previous year alone. Closer examination of the reports indicate that out these cases there have been nine fatal cases where the patients passed away.
Also in Canada, Health Canada will refresh its security audits with respect to BIA-ALCL. In fact, as of January 2019, Health Canada has gotten reports of 22 affirmed and 22 associated Canadian cases with BIA-ALCL. In its underlying health survey in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 affirmed Canadian instances of BIA-ALCL detailed by Canadian producers over the most recent 10 years. Expanded mindfulness by social insurance experts and people in general about BIA-ALCL is accepted to be the biggest contributing variable to the expanded recognition of instances of BIA-ALCL by Health Canada.
These data are largely in line with findings in Europe. In fact, in France, there have been 53 cases of BIA-ALCL registered by the French National Agency for the Safety of Medicines and Health Products (ANSM) out of about 500’00 women who got breast implants in a period since 2011. Moreover, the ANSM recalled the textured breast implants from Allergan from the French market because there seem to exist data showing that textured breast implants may have a higher risk for the development of BIA-ALCL than smooth implants. Thasso reported on the issue.
In a new development in this issue, Health Canada, as of May 2019, has now has completed an update to their 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).
Moreover, in a very significant step, as of 24th of July 2019, the FDA took also action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.