Breast Implant Illness – an update

Breast implant illness (BII) is an overall phrase that has been used by some women who have breast implants to describe a broad spectrum of systemic (affecting their whole body rather than a single body part) symptoms experienced by them. These symptoms may include tiredness, joint ache, brain fog, memory loss and headaches but other symptoms have also been described.

The WHO (World Health Organisation) does not recognise “BII” as a medical diagnosis as it has not fulfilled the criteria to be classified as a disease. No scientific link between breast implants and these symptoms has yet been identified, however, many women who identify as having these symptoms experience varying degrees of relief after their implants are removed.

 

So, what is new?

In light of 3 recently published high quality scientific studies investigating the possibility of systemic symptoms associated with breast implants (often referred to as breast implant illness) I have written this update to summarise their findings to help with a deeper understanding of this possible entity.

One hundred and fifty patients were enrolled in the studies*, 50 of whom identified as having symptoms they attributed to their implants, 50 women with breast implants requesting removal or exchange with no symptoms they attributed to their implants and 50 who were undergoing mastopexy (breast lift) surgery with no implants.

Detailed information was collected from the patients prior to surgery as well as 3-6 weeks after surgery, 6-months and a year after surgery. Blood was also collected and breast implant capsule (the scar tissue around the implant) was collected from the first two groups at the time of their surgery.

Were there any differences in lifestyle between the 3 groups?
In short, yes: the first group (who identified as having symptoms they attributed to their implants) reported more marijuana use, more tattoos and more allergies than those in the other groups. The first group also had a significantly higher use of certain pain medications and other herbal medicines. Finally, they used social media significantly more than those in the other groups as their primary source of medical information.

Study Part 1:
What was this about?
This investigated whether there were any differences in relief of symptoms of patients that related to the way in which the capsule was treated at the time of surgery. The 3 approaches were an “en bloc” capsulectomy (which means the implant is removed within the capsule as one unit, requiring a large scar); a total capsuectomy (in which the whole capsule is removed via a normal sized incision) or a partial capsulectomy (in which around half of the capsule is removed).
Why was this studied?
The belief of many women who attribute systemic symptoms to their breast implants is that only an “en bloc” capsulectomy will succeed in alleviating their symptoms.
So, what did they find?
The findings were that there was no difference in symptom reduction based on the type of capsulectomy. However most (but not all) of these patients did demonstrate that they had at least a partial improvement in their symptoms after surgery, and this improvement lasted for at least 6-months.
Conclusions
In conclusion the way in which the capsule was surgically managed did not make a difference to symptoms.

Study Part 2:
What was this about?
This part of the study was to determine whether heavy metals are present in the implant capsules and whether there are statistical differences in the presence of heavy metals in those in women who attribute systemic symptoms to their breast implants compared with the other groups. A wide range of substances were studied.
Why was this studied?
Many women who attribute systemic symptoms to their breast implants believe that they might be being poisoned by heavy metals leaking from their breast implants into the capsules and then into their blood stream.
So, what did they find?
Heavy metals were found in all three groups, including the last group, which was composed of women who had never had a breast implant (and indeed the levels recorded in this group were higher than in the other two groups). The only statistically significant differences found in the first group were higher levels of arsenic and zinc (both of which were actually found in amounts lower than the acceptable daily intakes), lower levels of cobalt and manganese, silver and tin.
However, there were “confounding factors” in the group of women who attributed systemic symptoms to their breast implants – women in this group had higher rates of smoking, gluten free diets (which often include higher amounts of rice or rice flour, which are a high source of arsenic and other heavy metals), dietary supplements and the presence of tattoos, all of which are significant sources of arsenic and zinc.
Conclusion:
In conclusion there was not a significant risk of heavy metal exposure from breast implants.

Study Part 3:
What was this about?
This part of the study aimed to investigate whether there was a difference in inflammation or infection in the capsules between the three groups. Also studied were differences in thyroid hormones, vitamin D levels and blood counts between the groups.
Why was this studied?
Some women who attribute systemic symptoms to their breast implants believe that their symptoms might be caused by an underlying infection or exposure to silicone particles.
So, what did they find?
No statistically significant differences were found between the first two groups’ capsules in relation to infection or inflammation, apart from those women in group 2, who had higher rates of capsular contracture, which would be expected to have higher rates of inflammation.
The presence of silicone particles on the capsules was actually lower in the first group (women who identified as having systemic symptoms) compared with the second group.

Interestingly, specific markers of inflammation from blood tests (e.g. CRP) were higher in the first group. The confounding factors are that this group had higher rates of thyroid disease, allergies and smoking, all of which can result in the elevation of these markers. In addition, anxiety, which was reported with a higher prevalence in this first group, has been associated with raised levels of other markers of inflammation that were also detected at higher levels in this group.

Conclusion:
The DNA, microbiology and antibody data from this study failed to demonstrate an infectious theory as a primary cause for the systemic symptoms reported in BII. In addition, there was no evidence of small silicone particles being a likely cause of symptoms.

Study Limitations:
All scientific studies have limitations. Whilst this series of studies is probably the most accurate study on this topic to date, and uses the very latest state of the art technology, there were relatively limited numbers – 50 in each group. These groups were large enough to produce meaningful data, but even larger groups would be beneficial for further study.
Systemic symptoms are by definition subjective, and cannot be accurately measured or verified, so this also introduces a variable that is hard to control.

*
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208825/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9400612/

https://academic.oup.com/asj/advance-article/doi/10.1093/asj/sjac225/6671500?login=false

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“No-one knows what it is like to be in someone else’s skin”

This was a comment made during a consultation recently with a patient, and I think it perfectly summarised how important it is not to be judgemental or opinionated about people’s life choices, particularly when it comes to plastic surgery or aesthetic procedures.

I am only too aware of the widely varying views people might have about plastic surgery, and it frustrates me whenever I hear negative comments that are inevitably pejorative and condescending about an individual’s choice. You can only imagine the number of conversations I have on this topic when I am introduced to people who then find out what I do professionally! I sometimes have this situation arising with some medical colleagues from other specialties, and from general practice, which I find particularly disappointing. I expect these opinions are fuelled by the portrayal of stereotypical exaggerated cosmetic treatment outcomes in the media…which in no way reflect the broad spectrum that exists in reality.

I often describe myself as a psychologist, who happens to use surgical therapies rather than talking therapies to improve the self-confidence and self-esteem of my patients, and I see evidence of the benefits and effectiveness of this concept day in, day out.

People might consider undergoing elective plastic surgery for a number of reasons, but the fundamental link most have is related to self-confidence and self-esteem. At the end of the day, it is about how one feels about oneself, not about what anyone else thinks – how it feels to live in one’s own skin. If someone radiates positivity and self-confidence, it is reflected back everyday in their lives and becomes a virtuous cycle. If someone lacks confidence or feels insecure, it can lead to a progressively attritional negative cycle. In selected situations, plastic surgery is the right choice to address this.

There are innumerable occasions when I have heard incredibly rewarding comments following plastic surgery – “you’ve changed my life”; “this is the best thing I have ever done”; “I cannot thank you enough”; “it has transformed my relationship”; “finally I can go swimming/on holiday/wear a bikini”…I could go on! The positive impact plastic surgery can have is incredible – albeit in those who are fully informed, are aware of the risks, and in particular have realistic expectations.

We often talk about our quality of life, but perhaps those who are judgemental about plastic surgery do not consider this in relation to other people when they have a dogmatic resistance to differing perspectives and points of view. Life is not only about getting by or managing, it is also about quality, interpersonal relationships, and enjoyment – “life is for living”. Elective plastic surgery can have a tremendously positive impact on people’s quality of life, and one that is usually not short-lived.

The long-term positive effects can be evidenced in a number of ways. One simple example is when I consider my patients who have undergone breast implant surgery. Inevitably at some point their implants will need changing, or further breast surgery will be indicated, sometimes 10-20 years later. I always offer the opportunity to have the implants removed, but the most common response is a definite “no”. Even in cases when someone might have experienced discomfort, pain or significant issues relating to the appearance of their breasts due to their existing implants, most would rather have further surgery that involved new implants, than would want them removed. This is surely evidence of the long term net positive effects of having breast implants for these women in this example. There are countless other examples too, in the arena of facial rejuvenation or body contouring too.

Of course, nothing is permanent, and “maintenance” is a common word used in plastic surgery – whether it is ensuring core muscle exercises are performed and maintaining a healthy weight after tummy tuck surgery or having non-surgical interventions to prolong the rejuvenation effects of a facelift.

Proceeding with plastic surgery is a big decision, and if you are considering it you should be well informed, reflect on the reasons you would be having it for, the long term effects, and the inevitable changes in the effects of the surgery over the course of time, with ageing and gravity being unavoidable.

Plastic surgery is not magic – it is not going to solve all the concerns and problems an individual might have. However, it has the potential to make an incredibly positive contribution to the quality of life of many people.

So I hope that if someone who might have had a judgemental, dogmatic and negative opinion of plastic surgery, and those who undergo it has read this, they might pause to reflect on the variety of views and concerns people might have. Just because they might not consider plastic surgery themselves, I strongly feel they should not brandish anyone who would have plastic surgery in a negative way, after all, they do not know what it is like to live in someone else’s skin.

 

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New Coronavirus Measures

We are delighted to say that we have made plans to re-open Purity Bridge on 1st June to start seeing patients following our closure of the clinic since mid-March. However, as we are sure you will appreciate, we have taken extensive measures to maximise your safety and the safety of our staff.

All patients attending the clinic will be sent a COVID screening questionnaire that must be completed prior to the appointment. If any answers to this questionnaire raise any “red flags”, you will be contacted and if necessary, the appointment rearranged.

Therefore we will be requesting that anyone attending the clinic for an appointment arrives wearing a face mask or nose and mouth covering. We would also request that you attend your appointment alone so we minimise the number of people in the building at any one time. Please therefore arrive for your appointment on time – we apologise in advance if we turn you away if you arrive early!

There will be alcohol gel for you to use on arrival and departure from the clinic and other strict protocols in place – please see below for more information.

Finally, in order to ensure that in-person clinic appointments are only for those whose needs cannot be met via video consultation, we will only be arranging in-person appointments for people coming for clinical examinations, treatments and procedures, and for post-surgical follow-up appointments. All other appointments will be via secure video link.

The clinic rooms will be thoroughly cleaned between each appointment and at the end of each day, and our staff will be wearing appropriate PPE as set out by Public Health England and other authoritative bodies.

We appreciate it will take some time getting used to the new way of doing things, and appreciate you bearing with us with these new measures.

 

Protocol for patients attending Purity Bridge

  1. Patients to complete on-line screening questionnaire within 48 hrs of appointment
    1. If screening questionnaire ok, patients can attend
      1. Screening questionnaire to be on-line
      2. Alert is raised if red flagged answer
    2. If screening questionnaire raises anomaly, situation to be discussed and risk assessed on a case by case basis including phone call to patient
    3. Outcomes might be either to allow patient to attend, to postpone appointment for a further 1-2 weeks or to advise the patient to seek medical attention prior to re-booking.
  2. All patients to wear face mask/mouth & nose covering for clinic attendance
    1. If patient comes without, we can supply on arrival
  3. Patient to be provided with alcohol hand gel for use on arrival
  4. Ideally patient to proceed straight to clinic room on arrival
    1. If patient required to sit in waiting room, patient to be directed to a specific seat by Front of House (seat to be wiped down after use)
  5. Patient to wear mask throughout time in clinic – only to be removed if necessary for clinical examination or treatment
  6. Patients to use alcohol hand gel on departure

Further measures:

  • No refreshments to be provided to patients – unless required after a procedure (clinical judgement)
  • If patients require toilet facilities they should be instructed to follow the signage regarding wiping surfaces

 

 

 

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New Coronavirus Safety Measures at Purity Bridge

We are delighted to say that we have made plans to re-open Purity Bridge on 1st June to start seeing patients following our closure of the clinic since mid-March. However, as we are sure you will appreciate, we have taken extensive measures to maximise your safety and the safety of our staff.

All patients attending the clinic will be sent a COVID screening questionnaire that must be completed prior to the appointment. If any answers to this questionnaire raise any “red flags”, you will be contacted and if necessary, the appointment rearranged.

Therefore we will be requesting that anyone attending the clinic for an appointment arrives wearing a face mask or nose and mouth covering. We would also request that you attend your appointment alone so we minimise the number of people in the building at any one time. Please therefore arrive for your appointment on time – we apologise in advance if we turn you away if you arrive early!

There will be alcohol gel for you to use on arrival and departure from the clinic and other strict protocols in place – please see below for more information.

Finally, in order to ensure that in-person clinic appointments are only for those whose needs cannot be met via video consultation, we will only be arranging in-person appointments for people coming for clinical examinations, treatments and procedures, and for post-surgical follow-up appointments. All other appointments will be via secure video link.

The clinic rooms will be thoroughly cleaned between each appointment and at the end of each day, and our staff will be wearing appropriate PPE as set out by Public Health England and other authoritative bodies.

We appreciate it will take some time getting used to the new way of doing things, and appreciate you bearing with us with these new measures.

 

Protocol for patients attending Purity Bridge

  1. Patients to complete on-line screening questionnaire within 48 hrs of appointment
    1. If screening questionnaire ok, patients can attend
      1. Screening questionnaire to be on-line
      2. Alert is raised if red flagged answer
    2. If screening questionnaire raises anomaly, situation to be discussed and risk assessed on a case by case basis including phone call to patient
    3. Outcomes might be either to allow patient to attend, to postpone appointment for a further 1-2 weeks or to advise the patient to seek medical attention prior to re-booking.
  2. All patients to wear face mask/mouth & nose covering for clinic attendance
    1. If patient comes without, we can supply on arrival
  3. Patient to be provided with alcohol hand gel for use on arrival
  4. Ideally patient to proceed straight to clinic room on arrival
    1. If patient required to sit in waiting room, patient to be directed to a specific seat by Front of House (seat to be wiped down after use)
  5. Patient to wear mask throughout time in clinic – only to be removed if necessary for clinical examination or treatment
  6. Patients to use alcohol hand gel on departure

Further measures:

  • No refreshments to be provided to patients – unless required after a procedure (clinical judgement)
  • If patients require toilet facilities they should be instructed to follow the signage regarding wiping surfaces

 

 

 

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What will surgery look like after lockdown?

The Coronavirus pandemic will have changed life for all of us in recent times. Surgery and medicine are at the forefront of its impact. Specifically, this will have had a significant impact on aesthetic surgery. Aesthetic surgery is elective surgery – therefore it needs to be as safe as possible and, in this case, we need to minimise the risk of lung complications and other potential COVID related side effects.

Bearing this in mind I have been having numerous conversations with colleagues, both surgeons and anaesthetists, about how we can maximise the safety of my patients in the future, once elective surgery can start up again.

One very promising approach is to reduce the number of patients having general anaesthetic procedures, making more use of sedation and local anaesthetic. This is something we already do for a variety of procedures, so we have a lot of experience with it. Therefore, extending its use to more procedures is something we are very comfortable with in the future.

For example, in the same way as caesarean sections are performed with spinal anaesthesia, we could perform tummy tucks in a similar way. We already perform local anaesthetic facelifts for less invasive approaches, so adding sedation will help us to perform more extended and involved facelifts in a safe and comfortable environment. Finally, breast surgery is an area that we can perform under local anaesthesia with sedation by combining the use of local anaesthetic with “regional nerve blocks” where some of the main nerves that provide sensation to the breast are targeted by specific injections.

Whilst these approaches may add some time to the procedures, they might help increase the safety profile with respect to COVID-19, and therefore I feel that this is an approach well worth considering. Every case will be reviewed on an individual basis, and the best overall plan made for each of my patients.

Exactly how we will be doing things moving forwards is still uncertain. We have the advantage of watching how other countries are starting back up – from Europe to the US, so we will be able to learn what works (and what doesn’t) from them.

Coronavirus testing will inevitably be crucial – when quick results turnaround testing becomes more widely available it will be transformational. Prospective surgical patients will be tested (and isolated as appropriate between testing and results) but also staff will need to be tested on a regular basis to ensure they are not asymptomatic carriers of the disease.

I am sure testing like this will become routine in due course, but again, I don’t yet know when.

So, there does seem to be some light at the end of the tunnel, but we should not be too hasty in getting back to elective surgery until we are as confident as we can be about minimising risks to our patients and the healthcare staff.

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ALCL – how do I know if I may have it? What does it look like? What should I do?

I wanted to write a blog to talk about BIA-ALCL – breast implant associated anaplastic large cell lymphoma.  There is a lot written about it in the media at them moment (and rightly so) but unfortunately I see a lot of inaccurate reporting and understandably lots of worry is created.

BIA-ALCL is a rare form of lymphoma (cancer of the immune system) associated with textured breast implant surface. To date, no causal relationship has been found – i.e. we do not know if textured breast implants cause ALCL, but we do know that in all cases of BIA-ALCL so far, the patient either has or has had a textured implant in place.

Not all texturing is the same – it seems that the rougher the texture, the greater the association. In my practice for many years I have predominantly used Mentor (Johnson & Jonhson) breast implants, which have microtexturing, in other words, fine texturing. The best estimate for the development of BIA-ALCL with Mentor textured breast implant is around 1:86,000, so fortunately, very unlikely. Furthermore over 90% of cases are cured by removal of the breast implant and surrounding capsule (scar tissue).

So…how would you know if you were developing BIA-ALCL?

The most common symptom is spontaneous breast swelling (usually one but can be two) normally at around 8-years after the implants were put in. Therefore if you notice one of your breasts starting to swell, please seek medical attention straight away. There are benign causes of breast swelling too, so just because your breast starts to swell, it does not necessarily mean you have developed ALC. In fact, the last 3 patients I have seen with this symptom all proved to have benign underlying causes.

Sometimes patients present with a lump they have found, so it is important that you regularly check your breasts for lumps once a month, as normal.

What happens if I have a swollen breast?

The first thing, as I mentioned above, is to seek medical attention – either come back to see me or see your GP. After a careful medical history and clinical examination, an ultrasound scan may be organised. This is useful for two reasons – the first is to identify whether there is fluid around the implant causing the swelling; the second is to enable a needle to be introduced to take a sample of the fluid to be sent off for testing.

There are very specific tests for BIA-ALCL that can be done on any fluid that collects around an implant.

What happens if the fluid comes back diagnosing BIA-ALCL?

If you were to be diagnosed with BIA-ALCL there would be some more tests that would need to be done, and your situation would be discussed in a breast cancer MDT (multi-disciplinary team meeting). If the tests suggest that the ALCL is confined to the capsule (which it normally is) then surgery to remove the breast implant and capsule would be planned.

If there is more advanced ALCL (which is much less common) then other treatment options as well as surgery might be suggested, such as chemotherapy and radiotherapy.

 

It is important to state again that this is a rare entity and by far the majority of cases are completely curable with surgery, which I hope is reassuring.

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Breast Implant Illness – what we know, and what we don’t know

What is Breast Implant Illness?
A small proportion of women who have breast implants (for both aesthetic and reconstructive purposes) self-identify as having a number of symptoms they believe arise from the presence of their implants. Whilst not a medical diagnosis, they refer to their symptoms as Breast Implant Illness (BII).

What are the symptoms of Breast Implant Illness?
As stated above, Breast Implant Illness is not a medical diagnosis, but rather a term developed by those who have a variety of symptoms they feel are related to their breast implants. These include tiredness, “brain fog”, joint aches, immune-related symptoms, sleep disturbance, depression, hormonal issues, headaches, hair loss, chills, rash, hormonal issues and neurological issues.

Why has BII suddenly come to light?
It appears that the recent increase in patients reporting symptoms of BII is related in great part to social media. One Facebook group alone has more than 50,000 members who report symptoms of BII. This may account for the sudden increase in awareness of BII, however, BII is not an official medical diagnosis (see below).

Could these symptoms be caused by any other factors?
There are a variety of other reasons these symptoms might be found. These include other background illnesses or hormonal changes. In addition, there have been a number of scientific studies investigating similar symptoms experienced by women in the population in general.

For example, a Swedish study looking at a random sample of 4,200 women between 35-64 years old found a significant number experienced similar symptoms to those ascribed to BII, although they did not have breast implants. They concluded that the symptoms related to stress and depression.

A 20-year study on a Danish study population with breast implants regarding musculoskletal symptoms concluded that interestingly, the occurrence of mild, moderate and severe musculoskeletal symptoms was generally lower among women with implants, compared with women with other cosmetic surgery and women in the general population.

Do symptoms of BII improve when breast implants are removed?
On the whole, around 50% of women who self-identify as having BII feel that their symptoms improve after implant removal – sometimes temporarily and sometimes permanently. It therefore appears that removing breast implants does not necessarily improve symptoms in everyone. There is no research demonstrating which symptoms may or may not improve with implant removal – with or without removing its surrounding capsule (scar tissue).

In more detail:
A study on breast implant removal from 1997 (when older, less robust implants were still in use) looked at women in whom 186 implants had been removed. Over half the implants were ruptured or leaking, and many had other issues. Therefore in this study population, the women would theoretically have had a significant exposure to silicone from within the implants (compared with the more modern implants used today). Immune system blood tests showed no difference in levels of autoimmune antibodies between the study population and a control group of women without breast implants. The small number of women in the study group with diagnosed autoimmune conditions did not have any improvement when questioned over 2-years after implant removal. However, the majority of women reported an improvement in their psychological well-being after implant removal.

Is there medical evidence linking medical grade silicone to immune system problems or other diseases?
In short, the answer so far is no. Medical grade silicone is derived from the natural element, silica. Whilst silica has been shown to activate the immune system, silicone used in breast implants is very different, and to date has not been shown to cause any disease. Medical silicone does not exist is nature and is created to form polydimethylsiloxane. Medical grade silicone has had antioxidants, dyes, and plasticizers removed during processing.

Whilst there is no current evidence to support a direct link between breast implants and any specific disease process, it does not mean further research is not indicated. As stated below, further new research is being conducted principally in Australia and USA. It is important to recognize that in rare diseases (of any type), it can take many years to come to a scientific conclusion. In addition, there are many factors that can influence and confound the interaction of a patient and her breast implants – all of which have an impact on studying an entity such as BII.

A lack of evidence to date does not mean that the symptoms experienced by patients are not real. Therefore, as plastic surgeons, we take these symptoms seriously and are committed to supporting further investigation and research in this area.

Do tests exist for BII?
There are no tests that can show BII. However, there are a number of research studies underway, principally in Australia and the USA hoping to provide further information. In the meantime, there are tests that can be performed for autoimmune conditions. In a similar way to the population without breast implants, there are breast implant patients who have symptoms (they attribute to BII) with positive immune testing and others where all tests show no abnormalities.

What scientific data are there that shows that breast implants actually cause the symptoms of BII or any other disease?
To date there is no demonstrable link between breast implants and any systemic illness. There have been a variety of studies designed to look at the safety of breast implants and these have also looked at specific autoimmune disorders and diseases. Overall, these studies have shown few or zero links between breast implants and any disease. These studies have not shown any consistent laboratory test abnormalities to enable a distinct syndrome to be defined or categorized.

However, as in all areas of science, “absence of evidence does not equal evidence of absence”. Therefore further studies are on-going to investigate other possible links and symptoms in women with breast implants.

What should I do if I think I might have symptoms I identify with Breast implant illnesss?
If you experience symptoms you feel might be related to your implants it is important you see a doctor. It is important to bear in mind that your symptoms might not be related to the implants, and that other medical investigations should not be overlooked or ignored. Therefore you should involve your GP in the first instance to exclude any other underlying disease processes, such as autoimmune conditions, inflammatory conditions or neurological disease processes.

Should you wish for your implants to be removed, you should discuss this with your plastic surgeon. Most commonly, when patients are seeking to have their implants removed for symptoms they attribute to BII they request that their capsule is removed. This can either be done “en bloc”, referring to the whole capsule being removed containing the implant, or by other techniques. There is no evidence that en-bloc removal offers any benefit to the patient, and indeed this technique is more invasive and requires larger incisions. This should be borne in mind when discussing your situation with your plastic surgeon.

The “en-bloc” concept is one of the medical inaccuracies perpetuated on the internet and on social media. It is important to appreciate that sometimes it is impossible to remove the capsule without making a hole in it, even in the most experienced surgeon’s hands. Sometimes it is also not possible to remove the whole capsule, depending on how adherent it may be to the ribs, for example.

What is the risk of developing BII?
Due to the lack of official medical diagnosis, the disparate array of symptoms reported and the lack of definitive evidence, there is no “known” risk for BII. Many of the symptoms described by those identifying with BII are experienced by the general public on a regular basis, with or without implants. It is also important to understand the other recognized risks of having breast implants – related to the surgery itself and the long-term possible effects of having breast implants.

In summary, Breast Implant Illness is a phenomenon being discussed increasingly on the internet. As no link between silicone breast implants and a specific disease has yet been identified, more research is underway. Plastic surgeons need to listen and acknowledge that their patients may be experiencing symptoms, but must also ensure a general medical work-up to investigate other causes. Any woman concerned about symptoms of BII should feel comfortable bringing this up with their plastic surgeon.

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Dr Instagram…

With so much information out there on the Internet of a variety of quality, it can be hard to know where to look for credible and honest information. Social media is such a dominant presence on-line, that many doctors are using it to educate and update their followers about a wide range of topics.

I have been using Instagram for just over a year, and I’ve found it incredibly helpful to demonstrate and discuss all sorts of aspects of plastic surgery. These include how operations are done (with some actual video clips from the operating theatre), updates on the world of plastic surgery (as well as the latest news from conferences around the world) and educational pieces and photographs that I hope my followers find interesting!

My Instagram handle is @marcpacifico – why not have a look (and follow me!) to see the sort of content I post.

With such a fast paced and ever-moving world, I think Instagram provides an excellent platform for me to keep you informed and educated about my world of #plasticsurgery

If you have any questions or would like me to post on particular topics, please let me know, or message me directly on Instagram!

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A short note about risk

As you will appreciate, there are risks with any medical or surgical procedure. These risks vary, and some of the variation will depend on the procedure itself, whilst other influences will include your medical and genetic background, smoking and sun exposure history and more.

On the whole, the incidence of surgical/medical risk is quoted according to population studies. In other words, a study may, for example, look at 1000 patients undergoing a particular procedure and work out the number (or percentage) who get a wound infection. They may find that, say, 5% of the study population get a wound infection. This figure may then be used as an indication of the likelihood (or risk) of getting a wound infection if undergoing this particular procedure.

So, if you then read that there is (in this example) a 5% risk of wound infection it gives you some information. However, whist you may hear that there is a 5% risk, it does not (and can not) tell you whether you will be in the 5% who get the wound infection, or the 95% of people who do not! So, perhaps not as helpful a statistic as it appears at very first glance…

How you interpret this statistic is also very individual and varies between people.

In addition, how the risk is presented to you can significantly influence your thoughts. For example, you may feel that 5% is quite a low risk, however, if you were told that the risk of infection was 1 in 20, you may feel that is high. In reality of course, these statistics are exactly the same.

At the end of the day, no-one can undergo a procedure with zero risk. Therefore everyone must weigh up the pros and cons of exposing themselves to risk, and then take a view on whether they feel it is “worth” exposing themselves to risks – of a complication, an adverse outcome or the risk of potential dissatisfaction with a procedure.

Surgery is not an exact science – there are factors out of the control of the surgeon and the patient. These are a result of genetics, smoking history, sun exposure, environmental factors, and many more.

Whilst risk cannot be eliminated, it can be minimised and I will always strive to do this, with my advice, surgical technique, and after care instructions. Importantly, if you are unlucky enough to have a complication, I will always ensure I look after you and get you through it.

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Detailed information about BIA-ALCL

I have recently received an email from the American Society of Aesthetic Plastic Surgeons (ASAPS) that provided a clear and well-written detailed patient guide to anaplastic large cell lymphoma, something that I always discuss with my breast implant patients. This is a very rare, but important, breast implant-related cancer of the immune system, that is being discussed more in the media.

I thought it would be useful to publish the ASAPS Q&A patient guide here. If you have any more questions or concerns, please do not hesitate to get in touch.

BIA-ALCL: Patients’ Frequently Asked Questions

Q: What is BIA-ALCL?

A: : BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a rare spectrum of disorders that can range from a benign collection of fluids around the breast implant (seroma) to a rare lymphoma. BIA-ALCL is not a cancer of the breast tissue itself. When caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

Q: What are the symptoms of BIA-ALCL?

A:  The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation.  The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.

Q: What is the risk of developing BIA-ALCL?

A:  Based on current data, the risk can be explained by the texture grade of the implants as follows:

  • Grade 1 (Smooth only) – The current lifetime risk is zero.
  • Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
  • Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
  • Grade 4 (e.g. Polyurethane) – 1:2,800*

Q:  Have there been any deaths due to BIA-ALCL?

AThere have been 16 confirmed deaths, (globally), attributed to BIA-ALCL since the disease was first reported nearly 20 years ago. However, when detected early before it becomes a lymphoma, BIA-ALCL is readily cured with removal of the implant and surrounding scar pocket or capsule.

Q: Is it a problem with Saline or Silicone implants?

A: Of the 414 reported cases of BIA-ALCL, 312 reports included information on the types of implants used. Of those,234 reported implants with silicone gel and 119 reported implants filled with saline. It appears to purely be related to the surface of the implant and not to what the implant is filled with.

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm

As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 9 deaths1. BIA-ALCL are counted for those with a confirmed pathology test, or ALK or CD30 biomarkers, or reported by health care professionals. There are 272 reports with data on surface information at the time of reporting. Of these, 242 were on textured implants and 30 on smooth implants. There are 413 reports with data on implant fill type. Of these, 234 reported the use of silicone gel-filled implants, and 179 reported the use of saline-filled implants.

Q: How does this impact those with breast implants?

A: ASAPS and ASERF emphasize that the most important issue for women with breast implants is to screen for breast cancer with self-exam, a regular physician exam, and mammography/ultrasound/MRI as recommended by their physician.  All women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.

Q: Why would my surgeon have recommended textured implants for me?

A: There are two primary reasons your surgeon may have recommended textured surface breast implants. First is that some data has shown a lower rate of capsular contracture (firm scar tissue formation around the implant). Second, all teardrop or anatomic shaped implants have a textured surface to help hold them in place. Some surgeons believe these implants can offer an enhanced shape for certain patients, perhaps with a reduced risk of rippling.  

Q. How is BIA-ALCL treated and what is the prognosis?

ACurrent recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a very common procedure performed by plastic surgeons, identical to what is done when an implant has ruptured or capsular contracture has developed. Smooth implants can be put back in or the patient can choose not to have implants. In all but a few cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or adjacent tissues, chemotherapy or radiation may be necessary. This has only been necessary in a small percentage of patients.

Q: Should patients have their implants removed because of a risk of BIA-ALCL?

A:  Since BIA-ALCL has only been found with textured breast implants, smooth implant patients do not need to be concerned.  For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA-ALCL. However there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.

Q: Should women with breast implants be screened for BIA-ALCL?

A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.

Q: What causes BIA-ALCL?

A: ASAPS, ASERF, the FDA, and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified.  Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study.  The best theory today is that a combination of four factors are required for the development of BIA-ALCL: 

  1. Highly textured implant
  2. Chronic bacterial-inflammation
  3. Genetic pre-disposition
  4. Time

The source of the chronic inflammation is thought to be bacteria that have been identified around the implants in affected breasts.  Evidence is accumulating that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing and cases are being monitored.

Genetic factors may play a role. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.

Q: Does ASAPS recommend against the use of textured implants?

A: The available data does not support discontinuance of textured implants. The best practice is always for the physician to discuss with each patient the known risks and potential complications associated with any procedure. It is important for the patient and her doctor to frankly discuss all options available, and the risks involved.

Every plastic surgeon offers patients options regarding breast implants in terms of sizing, shape, and surface. Depending on a particular patient’s needs, a textured implant may be preferable. The plastic surgeon must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured.  The patient must then make an informed decision, based upon her own assessment of her needs and the risks involved.

 

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