Dutch Study Links Implants to Increased Breast-ALCL Risk

Breast implants are associated with an increased risk — albeit small — of anaplastic large-cell lymphoma (ALCL) in the breast, according to Dutch researchers.

The results of the study, led by Mintsje de Boer, MD, of Maastricht University Medical Centre in the Netherlands, were published in JAMA Oncology.

 The study was prompted, the team explained, by the fact that the number of women with breast implants who have been diagnosed with breast-ALCL since 2008 has increased, with several reports suggesting a link between breast implants and breast-ALCL.

The researchers, therefore, performed a case-controlled study to determine the relative and absolute risks of breast-ALCL in women with implants.

Using the population-based nationwide Dutch pathology registry, de Boer and colleagues were able to identify patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and then retrieved their clinical data, including breast implant status.

Among the 43 patients with breast-ALCL (median age of 59), 32 had an ipsilateral breast implant (median age of 56) compared with only one patient among 146 women with other primary breast lymphomas, resulting in an OR of 421.8 (95% CI, 52.6-3385.2) for breast-ALCL associated with a breast implant.

The investigators also examined the connection between specific types of implants and breast-ALCL. Of the 28 patients with breast-ALCL with a known implant type, 23 (82%) had macrotextured implants, which was more than expected considering that less than half (45%) of implants sold in the Netherlands between 2010 and 2015 were macrotextured.

 When looking at the absolute risk for breast-ALCL associated with breast implants, the researchers determined that the estimated prevalence of 20- to 70-year-old women with a breast implant in 2015 was 3.3%, ranging from 2.3% for those ages 20 to 30, 4.0% for those ages 31 to 40, 4.2% for those 41 to 50, 3.6% for those 51 to 60, and 2.1% for those 61 to 70.

The cumulative risk of breast-ALCL in the general population increased with age, reaching about 0.35 per million at the age of 75. For women with implants, the cumulative risk increased from about 29 per million at age 50 to about 82 per million at age 70. De Boer and colleagues calculated that the number of women with implants needed to cause one breast-ALCL case before the age of 75 was 6,920.

“Our relative risk estimate of over 400, implying an attributable risk approaching 100%, is highly suggestive of a direct or indirect causal role of the breast implant-associated ALCL,” de Boer and colleagues wrote.

They also pointed out that their calculations concerning the absolute risk of breast-ALCL has multiple implications considering the relatively large number of women (3.3%) in the Netherlands having implants. These include the need for comprehensive counseling of women considering having breast implants for cosmetic or reconstructive surgery, alternative cosmetic/reconstruction procedures, and the establishment of a registry program for breast implants and their complications.

As for the study limitations, de Boer et al noted that retrospective data on the prevalence of breast implants were not available because of an absence of breast implant registration — which only began in the Netherlands in 2016 — and the lack of reliable and complete historical implant sales data.

“Therefore our absolute risks of breast-ALCL in implant carriers were based on extrapolated data. Even in this nationwide study, numbers were too small to allow definite conclusions on modifying factors, such as duration of implant exposure and implant types.”

In an accompanying commentary, Colleen M. McCarthy, MD, and Steven M. Horwitz, MD, both of Memorial Sloan Kettering Cancer Center in New York City, wrote that while de Boer and colleagues should be commended for their “rigorous approach” to defining the risk of breast-ALCL in patients with implants, the conclusions appear to “more confirmatory than new.”

For example, as noted in this article in MedPage Today, the FDA earlier this year affirmed a link between ALCL and breast implants, and suggested that women with implants should be regularly monitored for signs and symptoms of the disease.

De Boer et al “conclude that breast implants are associated with a strongly increased relative risk of breast-ALCL, yet the absolute risk of the disease presented here remains extremely low,” McCarthy and Horwitz wrote, pointing out that most women with implants newly diagnosed with ALCL are successfully treated with implant removal and capsulectomy alone.

“For a woman and her physician considering options for implant-based surgeries, differences in underlying beliefs and values among women will sway decision making in different directions. Thus, when considering options where there is uncertainty, it is particularly important that the process of decision-making be shared, because these decisions are highly dependent on individual patient preferences and assessment of risk.”

Deaths From Rare Cancer Linked to Breast Implants

CNN reports that nine deaths have been attributed to breast implants. In each case, a rare form of breast cancer, anaplastic large cell lymphoma (ALCL) was responsible. The FDA responded that this cluster was no cause for alarm as breast implants are linked to only a slightly increased risk of cancer.

Breast cancer is one of the most feared diagnoses a woman can receive. One in 8 women will develop invasive breast cancer in her lifetime. Genetics play a role in breast cancer but there are steps you can take to reduce your risk.

In the largest review of research into lifestyle and breast cancer, the American Institute of Cancer Research estimated that about 40 percent of U.S. breast cancer cases could be prevented by lifestyle choices. I believe this number understates the positive impact of lifestyle modifications.

One of the easiest to implement changes is to improve your diet. Refrain from consuming sugar, especially fructose, and consume only nourishing and whole foods. Processed foods are to be avoided and I recommend limiting protein intake and increasing healthy fat consumption. Obviously, you will want to optimize your gut flora and make sure GMO foods don’t sneak their way onto your menu.

Iodine may also be a crucial player in cancer prevention. Iodine is an essential trace element required for the synthesis of hormones, and the lack of it can also cause or contribute to the development of a number of health problems, including breast cancer. There is evidence that mega doses of iodine are counterproductive.

No matter what health challenges you face, I always recommend optimizing your vitamin D levels. There are hundreds of studies showing the importance of vitamin D. According to Carole Baggerly, founder of GrassrootsHealth, as much as 90 percent of ordinary breast cancer may in fact be related to vitamin D deficiency.


Cancer risk of breast implants ’10 times higher than first feared’: Shock warning from surgeons .. as one British survivor relives ordeal

The number of women at risk of blood cancer triggered by the most popular type of breast implant used in Britain has been ‘hugely underestimated’, warns a world authority on a newly emerging disease.

American plastic surgeon Professor Mark Clemens, who has been tracking cases since the first were reported in 2011, said while ‘still very rare’, the true incidence was ten times higher than women were often told.

Breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, has been identified in 173 patients worldwide. At least 11 of them are British.

However, the numbers currently being seen ‘could be just the tip of the iceberg’, according to one NHS breast surgeon who has treated three women with the disease in the past year.

BIA-ALCL is not breast cancer, but a type of ALCL, a cancer that develops in the lymphatic fluid, part of the immune system, which can circulate throughout the body forming solid tumours. Women aged from the mid-30s to over-60s have been affected, and problems are typically seen at least four years after the implant operation.

One patient struck down with the illness is 30-year-old Charlotte Fouracres, who claims she was not warned about the risk when she had an augmentation in April 2012 to take her from a B to a D cup.

Last July the teacher from Colchester, Essex, discovered a lump the ‘size of a 5p piece’ at the top of her right breast, near the cleavage, and sought medical advice.

The mother-of-four was referred by her GP to a breast-screening centre. It performed an ultrasound scan and needle biopsy, which confirmed ALCL. She started chemotherapy immediately, but the treatment failed to halt the disease.

After four months, scans revealed that her tumour had spread to her chest wall and was inoperable.

Charlotte said: ‘My right breast was swollen, felt burning hot and I had developed a red, itchy rash. I became unable to raise my right arm to brush my hair or teeth and could no longer cook or drive.

‘I felt absolutely lost with no control over my body. I had to contemplate the unthinkable – that I might not see my children grow up.’

With her disease progressing at an alarming rate, Charlotte’s doctors sought specialist help. She was referred to consultant breast surgeon Fiona MacNeill at cancer centre The Royal Marsden NHS Foundation Trust in London.

Ms MacNeill, who had treated two other patients with BIA-ALCL, said: ‘It’s a new cancer, so many doctors don’t recognise it when they see it.

‘To diagnose BIA-ALCL as distinct from ALCL, specific tests have to be carried out.

‘Although Charlotte was put on the correct treatment for regular ALCL, it is possible the BIA-ALCL does not respond well to the type of chemotherapy used to treat the more common form.’

Charlotte was given seven cycles of a £10,000 biological therapy drug called brentuximab. This mimics immune-system antibodies that attacked and destroy tumour cells. ‘This new drug was amazing,’ said Ms MacNeill. ‘The disease melted away in front of our eyes.’

This was followed by surgery in April to remove Charlotte’s implants, and she has been told she has no remaining cancer.

Charlotte with daughters Maisey (eldest), Ellie, (hairband), Imogen, her husban Chris and son George

Charlotte with daughters Maisey (eldest), Ellie, (hairband), Imogen, her husban Chris and son George

She will need monitoring for the next five years, with scans every three to six months and then yearly, to guard against recurrence.

She said: ‘After having two children, my body changed. I suppose I had the boob job to boost my self-esteem. Now, looking back, maybe having smaller breasts wasn’t such a bad thing after all.’

Earlier this month French health authorities confirmed a ‘clearly established link’ between implants and the development of BIA-ALCL.

Watchdogs the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) ordered manufacturers to prove the safety of their products or face them being banned. Under scrutiny are implants with a textured surface – the most common type in Britain, accounting for 99 per cent of all used.

The ANSM argues that it is vital that research is done into how these silicone prostheses interact with body tissues to ‘reduce the risk [of cancer] as much as possible’.

Some research has suggested bacteria on the outer shell introduced during implantation leads to immune system changes that trigger the cancer. However, this is not proven.

British body the Medicines and Healthcare Products Regulatory Agency (MHRA) has not revised its guidance since 2014. A spokesman said: ‘We will closely monitor the results of the investigation by the French Regulatory Authority and will take appropriate regulatory or safety action if needed.’

Charlotte Fouracres claims she was not warned about the risk when she had an augmentation in April 2012 to take her from a B to a D cup

Charlotte Fouracres claims she was not warned about the risk when she had an augmentation in April 2012 to take her from a B to a D cup

In most cases of BIA-ALCL, women are successfully treated with surgery alone, but chemotherapy and radiotherapy may also be needed.

There has been growing concern among the medical community about BIA-ALCL since 2011, when US health chiefs the Food and Drug Administration (FDA), the MHRA, and the World Health Organisation issued alerts to doctors and urged them to report cases.

Since then, doctors registered with the British Association of Aesthetic and Plastic Surgeons BAAPS, who represent all cosmetic surgeons working in the NHS, have warned patients of BIA-ALCL.

Consultant plastic surgeon and BAAPS council member Paul Harris said: ‘The risk is extremely low and the disease is almost always treatable. However, it is a duty of care and mandatory for any doctor to fully disclose the nature of any risks to a patient undergoing medical treatment, no matter how small that risk is perceived to be.’

But Prof Clemens, who has studied the disease in depth, believes the true scale of risk has been misunderstood. He says: ‘A figure of one in 500,000 has been quoted, but this is a huge underestimate. It does not take into account that it takes on average ten years after an implant for symptoms to occur.

‘Given this, the actual number is one in 50,000. Many women may have been told the risk is smaller than it is. The UK uses the same number of implants every year as in France, but only 17 cases are known in the UK compared to 29 in France, where they are very alert to the dangers of BIA-ALCL. All surgery carries risk. But patients must be properly informed about what those risks are if they are to make a decision on whether to go ahead with it.’

Charlotte says the disease was not mentioned by her doctors or their staff.

Approximately 29,000 women in Britain have breast implants, for cosmetic reasons or following breast-cancer surgery.

Dr Suzanne Turner, senior lecturer at Cambridge University’s department of pathology, who published a major study on the incidence of BIA-ALCL in 2014, agrees that the risk factor has been understated. She says: ‘I think we will see more cases as more women are reporting them.’

Ms MacNeill agreed, saying: ‘Because of the length of time it take for the disease to show, and because many doctors are not aware of it, women may have gone undiagnosed. It is rare, but there is the worry that the numbers we have seen so far are just the tip of the iceberg. Whatever the case, low risk does not equal no risk, and patients must be advised as such.’

What you need to know about breast implants

Today a shocking report into Australia’s most popular cosmetic surgery providerrevealed six patients undergoing breast implant surgery had life threatening complications. The Cosmetic Institute is also accused of knocking patients out without their consent, and administering drugs at a dangerously high level.

In an industry where the difference between a cosmetic and a plastic surgeon can be seven years of training – what questions should you be asking before you let anyone near you with a scalpel?

Have a chat to your GP

It might feel weird to ask your doctor about cosmetic surgery – you probably normally see them about the flu, not whether you look hot in a bikini. But if your doctor is a good one, they should give you unbiased advice on who you should speak to about surgery and whether it’s right for you.

Kate Browne – investigative journalist for Choice – has put together this handy guide for getting your boobs done. She says seeing a GP first is important because they won’t be “trying to sell you a package” and they might be able to recommend you a reputable surgeon.

“Make no mistake, you’re going to get very different levels of service depending on how you choose to go.”

If you are too awks to ask your GP, check your surgeon out on this website.

The Australian Health Practitioner Regulation Agency (AHPRA) keeps track of registered medical practitioners. If there’s been a complaint upheld against a doctor, you’ll be able to find evidence of it here. Also, it will give you their most up to date medical qualifications.

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Spot the difference: Cosmetic Vs Plastic Surgeons

Any GP can perform surgery. Yes, you read that right: there’s nothing to stop a general practitioner performing cosmetic surgery without any extra training. A plastic surgeon has been specifically trained in that kind of surgery.

“Having said that, some cosmetic surgeons are very practised and very good at their job, they’ve been doing what they’ve been doing for a very long time” says Kate Browne.

Which makes the next step really important:

Be prepared, ask lots of questions

Before you walk inside the surgery, make a list of questions. Kate suggests you ask the following:

  • What are your qualifications and experience?
  • How many times have you performed the procedure?
  • How many times have you performed it in the past six months?
  • Can I speak to previous patients?
  • Are there any complications associated with the procedure?
  • If complications do occur or the procedure is not successful, how will you deal with this?
  • Where will the surgery be performed?
  • Will a qualified anaesthetist administer the anaesthetic and/or sedative medication?
  • Who will be looking after me during the surgery?
  • Will I need time off work?
  • Are there post-operative side effects?
  • Will there be any visible scarring following the procedure? How can this be minimised?
  • What aftercare will be provided and will this be included in the treatment costs?

Two points that are particularly important; going under anaesthesia can be dangerous. And it’s expensive to hire a specialist anesthetist, so it’s an area that clinics can try to cut costs.

Another hidden cost is aftercare: if something goes wrong and you need follow up, how much will you have to shell out?

Kate says “everyone wants to think that their procedure will be straightforward and there’ll be no problems, but the reality is that doesn’t always happen.”

Saline Vs Silicone

Saline implants are basically full of salty water. Some say they don’t look as natural, but if they leak – the salty water will be absorbed by the body with fewer problems.

But if silicone leaks the gel can “escape into the scar tissue… that is a bit of health concern. It can cause pain or a change in breast change or size.”

Kate says the type of implant that will best suit you depends on your body type. So she advises going to a professional who do both types of implant.

Location Location Location

Where you’re having the surgery is important. Many clinics will perform the surgery right there. But you’re better off being in hospital or in a day surgery. Because – fingers crossed – if something goes wrong, you want to be close to the best resources possible.

“If you go into cardiac arrest, you can go straight into theatre [in a hospital]. And day surgery hospitals do have fairly strict regulations about the way they’re run and the kind of reporting they have to do.”

Every surgical procedure is not without risk.

“Our recommendation would be to avoid in-office surgery,” says Kate.

Holiday with benefits?

There are reputable hospitals overseas who do plastic surgery. But it’s hard to be 100% sure about the conditions of the hospital until you’re there.

And if you have complications or an infection and the flights are non-refundable or you can’t afford to stay overseas, you might be tempted to fly home. That can be risky.

A Melbourne man recently died after he flew home post-cosmetic surgery.


Even if you’re not thinking about kids in your early 20’s, you might want the option to breast feed later on. So make sure you talk with your doctor about that.

Be prepared for more surgery

Breast implants may need more work down the track.

“You are potentially looking at a lifetime of tweaks and potential future surgery,” says Kate.

“You need to be prepared to cover the costs of that.”