Textured breast implants and Anaplastic Large Cell Lymphoma
The British Association of Aesthetic Plastic Surgeons (BAAPS) has issued a statement on the Channel 4 Dispatches programme and concern over the safety of breast implants.
Full text from BAAPS:
24 June 2019 (Last updated: 24 Jun 2019 14:45)
The British Association of Aesthetic Plastic Surgeons (BAAPS) understands the concerns of patients and journalists expressed in the Channel 4 Dispatches programme aired on 24th June 2019. The programme has highlighted two main areas of concern – the first being a very rare form of cancer and the second being a poorly defined general illness. This statement sets out the BAAPS current advice to surgeons and patients regarding these concerns.
Over recent years, plastic surgeons have become aware of and studied a known link between breast implants that have a textured surface and the condition Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This is not a cancer of the breast tissue. It is a rare type of lymphoma which develops the fluid and internal scar, or capsule, around breast implants.
BIA-ALCL is very rare and, usually, eminently treatable. Several factors, including genetics, may promote the development of this condition, and current research suggests the risk in the UK is approximately 1 in 24,000 breast implants sold. For comparison the general incidence of breast cancer in the UK is 1 in 9 and affects women with and without breast implants equally. More guidance on BIA-ALCL can be found here.
Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions at this time. Texturing of an implant surface also offers advantages, particularly with more anatomically shaped implants. Hence many surgeons in the UK still advocate the use of textured implants for their patients. It is vital however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients prior to surgery so that patients can make informed choices.
Several different companies manufacture breast implants for both aesthetic and reconstructive use. These implants can have different types of texturing on their surface and some research has indicated that BIA-ALCL might be related to a particular type of texturing or manufacturing processes. One major company, Allergan, produces implants known as Natrelle® with a surface called Biocell®. These implants have been available Worldwide but only under licence. In Europe this licence is known as a CE mark.
Breast Implant Illness (BII) is a term used by patients who have breast implants and describe a variety of generalised symptoms that they feel are directly connected to their silicone implants. At this stage there is no scientific evidence to confirm this causal link or diagnostic test to show that a patient suffers from such a condition. Research continues in this area to establish if all of the symptoms that patients describe can be brought together into a single diagnosis. Some patients do report that their symptoms improve if their implants are removed but this is not true for all. More guidance on BII can be found here.
Because both BIA-ALCL and BII appear to be linked to the scar tissue, or capsule, around breast implants, many patients request that this capsule be removed at the time of implant removal. Some also believe that to be effective this capsule should be removed intact with the implant. This is known as an en bloc excision and can lead to much more extensive scarring with additional damage to the remaining breast tissue.
THE CURRENT SITUATION
Due to concerns over the possible link with Allergan’s textured surface (Biocell®), the CE mark was not re-awarded for this product in December 2018. Hence Allergan’s textured implants are no longer available for patient use in the UK. This was a precautionary measure until more data becomes available and Allergan continues to work with the authorities to clarify the issue. The BAAPS advised its member surgeons not to insert Allergan textured implants from December 2018.
Since December 2018, many regulatory bodies around the World have issued statements regarding their own position and some have limited the distribution of other textured devices. The advice does vary from country to country because the research data available is limited and not conclusive. None have called for the precautionary removal or replacement of textured devices that are already inside patients’ breasts.
Breast implants however are not lifelong devices and in general will need removal or replacement at some point. In an effort to have more robust data about both conditions, the Breast and Cosmetic Implant register (BCIR) collects breast implant data for patients in England and Scotland. The MHRA continues to collect and analyse UK information through a reporting system. It also has links with up to date information from international public health organisations. The most recent advice from MHRA on BIA-ALCL was updated on the 4th April 2019.
GUIDANCE FOR PATIENTS
There has been no change in the scientific evidence available in recent weeks despite the heightened media attention. The BAAPS advises that concerned patients need not take any action at this stage. They should continue their routine follow up with their healthcare professional and discuss any questions they have about their breast implants. There is no need to remove or exchange any current implants based on the most up-to-date scientific data available. Indeed, unnecessary surgery may cause additional harm in a small number of patients.
Paul Harris, President of BAAPS stated: “We recognise that patients are concerned about the potential to develop ALCL if they have textured, and particularly Allergan textured, devices in place. We need to remain vigilant and support patients wherever possible. However, it would be wrong to call for these implants to be removed or exchanged for other devices at this stage. Such surgery is likely to cause even more patient harm as no operation is without risk”. He continued, “We advise any patients with new symptoms such as swelling or pain to contact their implant surgeon for specific advice, otherwise they should make a routine appointment when available to discuss their concerns”.
Mary O’Brien, Vice President of BAAPS added “Breast implant illness is a lay term describing a wide range of symptoms experienced by group of patients that they attribute to their breast implant surgery. Currently this is not a recognised medical diagnosis and therefore there are no diagnostic criteria nor investigative protocols. The reality is that a small proportion of patients exist who are very troubled by these nonspecific symptoms. The BAAPS is an association that puts patients’ wellbeing at the very centre of its ethos. This group of patients deserve respect from clinicians in being listened to and supported going forwards. This support is not necessarily surgical. Further robust research is one way forward to find answers along with collaboration with the MHRA, breast implant registry and other professional associations and patient groups”.