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by Dr. Gregory T. Lynam

European Recall

One of the world’s largest manufacturers of breast implants, has
been blocked from selling several popular products in Europe
amid growing concerns over a link to a rare form of cancer.

International Consortium of Investigative Journalists

“Allergan, one of the world’s largest manufacturers of breast implants, has been blocked from selling several popular products in Europe amid growing concerns over a link to a rare form of cancer…Responding to the loss of Allergan’s CE marks, the British Association of Aesthetic Plastic Surgeons (BAAPS) on Wednesday said it had advised members not to insert Allergan textured implants from today. It said the health risks appeared to be small but needed to be better understood. “It is vital that the risks of using textured …implants are fully discussed with all patients prior to surgery so that patients are able to make informed choices,” the BAAPS said.”
https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe–pending-safety-review/

What are regulatory bodies outside of US saying about textured implants?

Regulatory bodies outside the United States issued communications on BIA-ALCL.The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings. The ANSM, “recommends that manufacturers having chosen to not carry out tests take the following into account during demonstration of biocompatibility:

• From a biological standpoint, a smooth surface and the different types of textured breast implant surface do not behave in the same way in contact with tissue. Each range of breast implant, according to shell texturing, should therefore be subjected to separate biocompatibility testing.

• Where biocompatibility tests are carried out, they should be carried out on sterilized breast implants (finished product) or on the sterile textured shell and on the breast implant gel.

• Physicochemical characterization of the materials in the various parts of the breast implant, and extracts taken from a biocompatibility study, are an essential prerequisite to compiling a breast implant biocompatibility study plan.

• The texture of the breast implant shell is to be taken into account when demonstrating biocompatibility.

• Extrapolation of biocompatibility data for smooth breast implants is not sufficient for demonstrating the biocompatibility of textured breast implants.

• Using the same materials for smooth and textured implants is not a good enough reason for justifying the biocompatibility of the implants as the interaction between the bodily tissue and shell texture is not taken into account.

• Using raw materials equivalent to those used to make other breast implants is not sufficient to demonstrate the biocompatibility of a textured breast implant.

• Data from scientific literature available on silicone implant biocompatibility, where it is used to demonstrate the biocompatibility of a breast implant, should be completed with biocompatibility data on the finished breast implant, in order to take into account all potential changes to the raw materials during the manufacturing process.

• Use of clinical data on other implant brands is acceptable if the breast implants can be shown to be equivalent, including in terms of manufacture and the physicochemical characterization of the shells.

• Clinical hindsight can be used to demonstrate the biocompatibility of breast implants if it provides information on biocompatibility, and if the clinical trials in question cover either the manufacturer’s own products or products with which equivalence has been confirmed; the effect of changes made to the product, and the impact of changes in standards and regulations should be taken into account for the period in question.

• The results of clinical trials can be used if their aim is also to demonstrate breast implant biocompatibility. Otherwise, preclinical trials should also be provided.

• The appearance of new biological effects in humans from breast implants should be taken into account during post-marketing surveillance, and as a result should be included in the biocompatibility test results.”

https://ansm.sante.fr/var/ansm_site/storage/original/application/aa533f4eacc8b36bd6504894235f7f29.pdf

On the Allergan website:

“Action Being Taken Following CE Mark Expiration and Compulsory Recall Request by AgenceNationale de Securite du Medicament (ANSM) –

Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, today announced that the company has suspended sales of textured breast implants and tissue expanders and is withdrawing any remaining supply in European markets. The withdrawal decision follows a compulsory recall request from AgenceNationale de Securite du Medicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products.

The complete article can be found on the Allergan website here: https://www.allergan.com/news/news/thomson-reuters/allergan-suspends-sales-and-withdraws-supply-of-te

The Australian Therapeutic Goods Administration (TGA):

The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 patients with confirmed cases of BIA-ALCL in Australia, including the deaths of 3 women. As of September 2016, TGA has confirmed 10 additional cases in Australian patients.

Per the Australian Department of Health Therapeutic Goods Administration (TGA) report regarding the French recall of textured breast implants published on December 21, 2018, “The TGA is aware that Allergan textured implants and tissue expanders are no longer being supplied in the EU as of 17 December 2018. Allergan has released a statement on its website.

The TGA will determine, following further discussion with Allergan Australia, what is an appropriate course of action here.

The TGA has been advised that the European conformity assessment certificate (referred to CE approval or EC Certificate) for Allergan’s range of textured breast implants and tissue expanders expired on 17 December 2018. The European Notified Body (GMED) which is anorganization that undertakes medical device technical evaluations, notified the French regulator (ANSM) it had requested Allegan to provide (by 31 March 2019) an updated technical file so that further clinical evaluation could be undertaken.

The full Australian article can be found here: https://www.tga.gov.au/alert/tga-statement-allergan-breast-implant-withdrawal-europe

JAMA Oncology – Letter to the Editor:

In a Letter to the Editor in JAMA Oncology, entitled Risk of Breast Implant Associated Anaplastic Large Cell Lymphoma, Dr. Eric Swanson wrote, “…45% of all implants sold in the Netherlands from 2010 through 2015 were macrotextured…almost no smooth implants are inserted in the Netherlands…In fact, the link between implant texturing and BIA-ALCL is so strong that this disease is not known to have occurred in a woman implanted only with smooth implants, when the implant history is known. If there were some overwhelming advantage of textured implants that would justify 405 BIA-ALCL cases as of October 2017, causing 2 deaths in the Netherlands and 15 deaths worldwide, perhaps there would be some room for discussion of benefits vs. risk…Many surgeons today, especially in the United States, use smooth implants exclusively…Conflicts of interest cannot be ignored…Those investigators who have received compensation from implant manufacturers, including favorable implant pricing, continue to promote textured implants, which are more profitable than smooth round implants…Abandon texturing and eliminate BIA-ALCL…”

https://jamanetwork.com/journals/jamaoncology/article-abstract/2688515

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