Safety Concerns about Breast Implants – BAAPS Update June 2019
There’s been a lot of news about a link between breast implants and a rare incidence of cancer BIA-ALCL, which has led to a medical company having one of its products, a textured implant, pulled off the shelf.
In response, the UK’s leading independent plastic surgery association BAAPS has released a statement (Mr Anthony MacQuillan is an active member of BAAPS).
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a very rare type of lymphoma which may be caused by implants. We say ‘may’, because as of yet there has been no proven link between it and implant insertion.
The main symptoms of BIA-ALCL include excessive fluid build-up around the implant, which can cause pain, swelling or lumps in the breast or armpit. These symptoms tend to occur from between three and 14 years after the fitting of the implant.
The good news is that BIA-ALCL is a rare condition – and eminently treatable.
In their statement, the British Association of Aesthetic Plastic Surgeons (BAAPS) pointed out that current research suggests the risk of developing this condition in the UK is approximately 1 in 24,000 breast implants sold.
To date, BIA-ALCL has only occurred in patients with a textured implant.
What are textured implants?
Currently, breast augmentation patients in the UK can choose between smooth and textured breast implants.
There are three main differences between these implants. Firstly, there is less movement with the textured implants because the surface composition means it ‘grips’ to the body’s tissues. They can feel firmer because the outer shell is thicker – although when placed in the body, particularly under the muscle, it is unlikely you’d notice any difference. Finally, there is less risk of capsular contracture occurring with textured implants which is why they have been such a popular choice.
For this reason, the majority of breast implants now used in the UK have textured surfaces, and according to all the latest scientific data these remain safe – and there is no medical reason for any woman to consider removing or replacing them.
All major breast implant manufacturers produce a textured implant and it is only one particular brand that is in the spotlight. The Allergan-produced Natrelle implants which have a Biocell textured surface have been flagged up by the EU regulators.
As of November of last year, all implants featuring Biocell lost the right to be used in Europe, meaning that these implants are simply not available to surgeons from 2019 – and BAAPS has instructed its registered surgeons (which includes us) not to use the product.
Should you be concerned about breast implant safety?
If you have had implant surgery and are worried you may be carrying a Biocell textured implant, BAAPS advises that you needn’t worry, as there is no need to remove or exchange any current implants based on the most up-to-date scientific data available. They stress that unnecessary replacement surgery may cause additional harm in a small number of patients.
They are also keen to point out that the removal of Biocell textured surface implants is a precautionary step taken by the regulators, whilst the link between breast implant surface and BIA-ALCL becomes clear, and advise any clients with new symptoms – such as swelling or pain – to contact their implant surgeon for specific advice. If there is no swelling or pain, they should discuss any concerns when they make their next routine appointment.
Bottom line: as in all surgical procedures, breast implant side-effects are a very rare occurrence, but the chances of them happening are always taken with the utmost seriousness by professional and reputable clinics such as ours.
Mr Anthony MacQuillan will always discuss the risks in depth with you during the consultation period, and we will also be on hand if you have any questions after surgery.
BAAPS BIA-ALCL Update June 2019
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
What is BIA-ALCL?
This is a rare type of lymphoma that affects women with breast implants. It is not a
cancer of the breast itself but can form on the capsule that surrounds a breast
implant. In 2016 the WHO provisionally classified BIA-ALCL as a novel type of
lymphoma.
How common is BIA-ALCL?
We do not know the exact incidence but it is thought to be around 1:20,000 to 1:60,000. For comparison the general incidence of breast cancer in the UK is 1 in 9 and affects women with and without breast implants equally. Cases of BIA-ALCL have occurred between 2-28 years after breast implant insertion with the average time being 8 years. Up to 2018 there were 414 reported cases of BIA-ALCL and 16 confirmed deaths worldwide from BIA-ALCL.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) collect all the data regarding suspected cases and publish regular updates, the latest of which can be found online.
What causes BIA-ALCL?
We do not know, but it is thought to be associated with the coating around some breast implants. Most of the cases worldwide have occurred in women with textured breast implants with a higher incidence seen in women with implants that have a coarser texture than those with a finer texture.
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 are able to 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.
Are there some types of implant that are not associated with BIA-ALCL?
BIA-ALCL is a rare condition so there are certain implants which the manufacturers say haven’t been associated with BIA-ALCL but the condition is too rare to say this for certain. It does appear that smooth implants have a lower risk of BIA-ALCL compared to textured implants.
Why don’t all plastic surgeons use smooth implants then?
Plastic surgeons are trained to use the full range of implants and there are significant advantages and disadvantages of both textured and smooth implants – BAAPS recommends you have a frank discussion about implant choice with your surgeon during your consultation to ensure you are fully informed about both implant types.
I have textured implants – should I be worried?
Whilst there exists some differences around the World regarding the availability and current use of some textured implants, there is no recommendation that patients with textured implants should have them removed as a precautionary measure.
The British Association of Aesthetic Plastic Surgeons (BAAPS) advises that concerned patients need not take any action currently. 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.
How will patients know they have BIA-ALCL?
Any onset of swelling, pain, increase in size in the breast over days or weeks should be investigated for BIA-ALCL. There are however, many causes for breast swelling which are not BIA-ALCL.
Is there any screening test for BIA-ALCL?
Currently there is no screening test but if patients with breast implants have any symptoms of swelling, lumps or pain they should seek urgent advice from their implanting surgeon or a BAAPS member plastic surgeon.
How is BIA-ALCL investigated?
This involves an ultrasound scan or MRI to look at the swelling, then a needle is used to take a sample of the fluid which is tested in the pathology laboratory to see if there any cells present showing markers for lymphoma.
How is BIA-ALCL treated?
This is treated by complete en-bloc surgical excision of the implant with surrounding capsule and involved local tissues. If the disease is confined to the capsule then surgical removal is usually adequate, however if there is disease outside of the capsule then patients may require chemotherapy. Recent developments in treatments that manipulate a patient’s own immune system appear to be very promising in gaining control of the disease, particularly if it has spread to outside of the breast.
This information sheet is produced for patients based on the most recent and accepted scientific research available – June 2019.
