TGA Breast Implants Recall – Updates about Textured Implants

TGA Announce Recall

Breast Implants Recall by TGA

In 2019, Following an extensive review that included laboratory testing and analysis of the available statistical data, the Australian Therapeutic Goods Administration (TGA) announce suspension and recall of specific breast implants for a period of six months, during which time the implant company will be able to submit additional information proving the implants’ ‘safety and performance’. The implants in question are those that have been linked to a higher rate of BIA-ALCL and other patient safety issues, otherwise known as Grades 3 and 4 of “macrotextured” implants and all “microtextured” implants.

In addition, there are new conditions on all breast implants and tissue expanders in that their manufacturers are required to provide more detailed information to surgeons and patients on possible side effects of implants including BIA-ALCL. Some implant manufacturers have made the decision to completely remove one or more of their implants from the market permanently. This follows implant manufacturer Allergan’s announcement earlier this year.

Implant manufacturers must also disclose any case of BIA-ALCL to the TGA within 10 days and submit twice-yearly reports containing information on their Australian and international supply of implants and including complaints received and “adverse events” including capsular contracture and rupturing.

BIA-ALCL – The Facts

It is important to note that BIA-ALCL is still considered extremely rare despite growing international concern. Keeping in mind that millions of women worldwide and around 40,000 women in Australia each year have breast augmentation with implants; there have been 23 deaths with 700 confirmed cases reported worldwide, 107 of these in Australia. Australian researchers identified 73.9 percent of these were linked to Grade 3 and Grade 4 implants, with 19.6 percent linked to Grade 2 implants. The TGA says, “The suspensions and cancellations [affect] 13 percent of the supply of breast implant devices on the Australian market by volume.” The Sydney Morning Herald reported, “All Australian cases have involved textured implants, the greater the texture, the higher the risk. The chance of developing ALCL from grade 4 implants was one in 2800 breast augmentations and one in 3300 for grade 3. The risk drops off markedly for the lesser textured grade 2 (one in about 84,000).”

To see the full list of recalled and suspended implants and to learn more about the content in this article, head to the TGA website.

The Therapeutic Goods Administration (TGA)’s breast implant expert working group met on Monday to discuss whether Australia follows France and Canada in banning textured implants. The TGA have been monitoring the link between breast implants and breast implant associated anaplastic large cell lymphoma (BIA-ALCL) since 2011 with the expert working group established in 2016, and convened the meeting in response to the decision by regulators in France and Canada to take several textured implants off their market.

However, the TGA joined other countries’ regulators including several in Europe and the United States FDA in deferring a definitive decision until further data is available. The group identified gaps in the information currently available in Australia on textured implants and BIA-ALCL so have taken several steps to rectify this including a formal request for all Australian suppliers of textured breast implants to provide dates and numbers of how many have been supplied to the Australian market. The group are also concerned with the different grades of texture on the implants and have asked suppliers to also provide samples of several of their products. Australian breast implant suppliers have 10 working days to respond to the requests.

While BIA-ALCL is rare, as of 8 April 2019 there have been 76 reports of BIA-ALCL in Australian women – all of them had textured implants. While this is a small percentage compared to the number of breast implant procedures in Australia which is estimated to be between 13,000 and 17,000 each year, the TGA says they take the potential risk to women’s health very seriously. In fact, it was Australian Plastic Surgeon Dr Anand Deva’s research on women with textured implants that contributed to France’s decision to ban textured implants.

Dr Deva’s research estimated that the risk of developing BIA-ALCL is 1 in 2,800, however the TGA’s official position on their website is that between one in 1,000 and one in 10,000 patients with textured breast implants are diagnosed with the condition.

implant manufacturer Allergan have announced a worldwide recall for all their Biocell textured implants and tissue expanders. This move comes in response to the link between textured implants and Anaplastic Large Cell Lymphoma (ALCL), a rare form of cancer which at last count had around 560 confirmed cases worldwide with 16 deaths.

The specific implants that have been recalled include Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants, Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

Allergan Textured Breast Implants Recall - TGA Announce Recall

Dr Naveen Somia

The Australasian Society of Aesthetic Plastic Surgeons (ASAPS) is urging Federal and State Governments to introduce a national screening program for women with textured breast implants to identify those at risk of ALCL and detect any implant ruptures, capsule formation, or fluid of seroma around the breast implant which can all be signs of implant infection. ASAPS say there is currently very little support for those patients with textured breast implants.

Dr Naveen Somia, President of ASAPS, said a screening program will help any woman feeling worried about having textured implants to be put at ease. “The clinics of our ASAPS Members have received hundreds of calls in the wake of the news that textured breast implants could be putting patients at risk of ALCL.”

Dr Somia also says there should be a social marketing campaign to support the screening program to help direct patients to the TGA website for reliable information.

Move by TGA to classify breast reconstruction as cosmetic surgery

An additional concern for ASAPS is that the TGA have moved to classify breast reconstruction as cosmetic surgery. This would deny some breast cancer patients access to breast reconstruction, proven to aid in the mental and physical recovery of patients post breast cancer. Dr Somia says it’s essential to keep breast reconstruction separate from cosmetic surgery in order to continue to support breast cancer patients. “Access to tissue expanders (which are microtextured) must be maintained. Tissue expanders are an essential component in breast reconstruction surgery, and many women would be significantly disadvantaged if these were not available. Tissue expanders are unlikely to be in situ for long enough (generally 3-12 months) to cause an ALCL if the hypothesis regarding causation is correct.

“Another vulnerable group who benefit from the use of textured breast implants are those who suffer from breast deformities due to radiation, burns, or congenital disabilities.”

It is important to note that most patients with textured implants will be fine and it is recommended that they do not need to take any action, however Dr Somia says any patient with textured implants who has noticed changes in their breasts should see a Specialist Plastic Surgeon who can do further examination to ensure the health of both the patient and their implant.

Benefits of Textured Implants – The Flip Side

The working group also discussed the benefits of textured implants. It has long been recognised that textured implants are less likely to move around in the patient’s body compared with smooth or teardrop implants. However, obviously patient safety is paramount and once the relevant information is received the TGA say they will consider whether or not to suspend or completely cancel particular textured implants from the Australian Register of Therapeutic Goods. It was also identified there is a need to update the TGA website with the most up-to-date information about both the benefits and risks of any implant, including the signs and symptoms of BIA-ALCL (the most common being swelling or a lump in the breast). The TGA have also confirmed the introduction of a new requirement for Patient Information Leaflets to increase patient access to information.

In the meantime patients with textured implants need to recognise that BIA-ALCL is a VERY rare disease. In fact, one of the reasons why it’s taken so long to compile data is that such a large number of women have them and are completely fine. If you have any symptoms and are concerned at all, contact your surgeon or doctor.

To read more about BIA-ALCL check out the blogs below:

Banning Textured Implants - TGA Announce Recall

What is ALCL? A Facebook Live with Dr Mark Magnusson tells you everything you need to know

Further Reading Related to Breast Implant