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What’s the problem with breast implants?
Assoc Prof Elisabeth Elder, ASBD President
Each year, approximately 20 000 women undergo breast implant surgery in Australia. Cosmetic augmentation accounts for about 80% and the remainder is reconstruction after mastectomy for breast cancer or for risk-reduction or rarely to correct developmental abnormalities. Recently there has been much publicity about risks associated with implants, particularly in relation to Breast-Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
BIA-ALCL is a rare form of non-Hodgkin lymphoma, which in 2016 was classified as a distinct clinical entity separate from other categories of ALCL. Characteristically it is ALK-negative and CD30 positive.
As the awareness of this condition has increased and more systematic research has been conducted, recent reports have shown that BIA-ALCL is more common than previously appreciated, with an estimated incidence of 1/1 000 – 1/10 000 people with breast implants. Furthermore, it has been shown that the risk of BIA-ALCL is related to the roughness, or degree of texturing of the surface of the implant, rather than the filling material or shape of the implant. The most likely cause is T-cell stimulation due to development of a chronic bacterial biofilm. The higher the degree of texturing, the larger surface area, and the higher risk for biofilm formation.
As of April 2019, there have been 76 confirmed cases of BIA-ALCL in Australia and all of these patients have had textured implants at some point – many of them have had multiple implants over a number of years.
There is some controversy regarding the most accurate classification system for implants but broadly speaking the surface texture can be divided into smooth, micro-textured and macro-textured. Example of smooth implants are Motiva; Mentor Siltex and Nagor are commonly used microtextured implants and Allergan Biocell as well as Eurosilicone are macro-textured due to different manufacturing processes. Polyurethane implants, such as Silimed, are different in that they are covered with a type of foam that adheres to the tissue and can therefore not be directly placed in the classification above, however, they have also been associated with a high risk of BIA-ALCL. The reason for using textured implants rather than smooth is better tissue adhesion causing less risk for malpositioning and potentially lower risk for capsular contracture. 82% of all implants used in Australia today are textured.
Earlier in the year, the French and Canadian regulators decided to ban macro-textured and polyurethane coated implants from their markets because of safety concerns. However, Allergan implants were already withdrawn from the EU market as well as from Brazil, due to a lapse in the EC certification. In July, the US regulator FDA requested that Allergan recall their Biocell textured implant and tissue expanders and subsequently Allergan has decided to recall all their non-implanted macro-textured breast devices globally, including in Australia.
Regulatory authorities around the world have issued alerts and warnings. The TGA has proposed regulatory action (ie suspension or cancellation) in a relation to a broad range of textured implants and a final decision is expected later in the year.
The most common presentation of BIA-ALCL is a delayed seroma formation around the implant occurring on average after 8 years, with 95% of cases occurring between 3 and 14 years after insertion of the implant. Occasionally BIA-ALCL may also present as a lump in the breast or axilla.
All patients who develop swelling around an implant should have an ultrasound to confirm the presence of fluid and evaluation of any potential mass or regional lymphadenopathy. However, it’s important to bear in mind that most cases of seroma are not caused by BIA-ALCL. An ultrasound-guided aspiration (biopsy) should be performed and the fluid (tissue) sent for BIA-ALCL specific analysis including cytology (histology) and flow cytometry +/- molecular studies. MRI +/- PET/CT should be performed in confirmed cases to evaluate the extent of the disease and a new MBS item number has been introduced for MRI in this setting. There is currently no role for mammography in the investigation of BIA-ALCL.
The only treatment required in most cases is removal of the implants as well as complete excision of the capsule around the implant, but chemotherapy and radiotherapy may be indicated in the rare instance of metastatic spread, and all cases should therefore be treated in specialised centres in a multidisciplinary setting. The prognosis is usually excellent although deaths have been reported in advanced cases.
The international consensus is that there is no evidence to support the replacement of current implants, unless there is a clear diagnosis of BIA-ALCL or other symptoms.
There is also consensus that registries are an important tool in the surveillance of breast implants. The Australian Breast Device Registry (ABDR) is a Commonwealth Government health initiative that was established in 2015 and is currently almost completing its national roll-out. It records information on surgeries involving breast implants, tissue expanders and acellular dermal matrices. Its purpose is to identify and report on trends and complications associated with breast device surgery; to track the long-term safety and performance of implantable breast devices; and to identify best surgical practice and optimal patient health outcomes. All surgeons, including plastic, breast and cosmetic surgeons, who are performing implant surgery (including explanation of implants) are strongly encouraged to participate in the ABDR and report all their cases.
Much of the safety data from registries will be enhanced by the pooling of data from similar breast implant registries existing in other countries. The International Collaboration of Breast Registry Activities (ICOBRA) was established as an Australian initiative to achieve this goal via the use of an agreed minimum dataset.
It is important to remember that although more common than previously thought, BIA-ALCL is still a rare condition and for breast cancer patients, the risk of developing BIA-ALCL needs to be put in perspective and is far less than the risk of developing recurrent breast cancer. Immediate or delayed breast reconstruction has been shown to have psychological benefits for women who need to undergo a mastectomy. Depending on a woman’s individual circumstances, an implant-based reconstruction is often the best choice.