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Regulator confirms link between breast implants and rare form of cancer

Posted: 15/05/2017


A new warning by the US Food and Drugs Administration (FDA) has underlined that women with breast implants are at increased risk of developing a rare but serious type of cancer called anaplastic large cell lymphoma (ALCL).

Penningtons Manches published an article on the link between breast implants and ALCL in April 2016. Since then the number of cases has risen. There have been 359 reported occurrences of the disease in the US, with nine of those affected having died; and 51 in Australia, including five who have died. In the UK there is currently no accurate data available but as of March 2016, there had been 14 reported cases. The purpose of this article is to provide an update on the steps that are being taken to investigate the association between ALCL and breast implants and to share issues that are arising from potential clinical negligence claims involving ALCL.

What is ALCL?

ALCL is a rare type of non-Hodgkin lymphoma. Like all lymphomas, it is a cancer of the lymphatic system - part of the body's immune system. ALCL develops when abnormal T-cell lymphocytes, a type of white blood cell, divide in an uncontrolled way. These build up in parts of the body like the lymph nodes, lungs or skin.

When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, ALCL has generally been found adjacent to the implant itself and contained within the fibrous capsule. Although it has been discovered in the breasts of some women with implants, it is important to be clear that it is not cancer of the breast tissue.

Development of ALCL is now recognised to occur, albeit at a very low frequency, in patients who have breast implants. In a typical case, a persisting seroma (build-up of fluid) occurs around the implant. More rarely patients will develop a lump with or without enlargement of axillary lymph nodes.

Initial alert

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a medical device alert in the UK in 2011 and a similar alert was issued by the FDA in the US. The recommendation of these alerts is that patients who develop persisting seroma following breast implant use should be investigated for the possibility of ALCL development.

The key literature - Miranda et al, Journal of Clinical Oncology 2014 - indicates that most patients with breast implant associated ALCL disease confined within the fibrous capsule achieve complete remission following treatment. Those patients who develop a mass lesion may have a more aggressive clinical course and require cytotoxic chemotherapy in addition to removal of implants.

The alert in 2011 was prompted when a study found that 34 women diagnosed with ALCL in a breast had implants. FDA scientists looked at results from other studies, consulted implant experts and manufacturers and contacted international health agencies. The scientists found six more US women and 24 women internationally who were diagnosed with ALCL in a breast with an implant.

The FDA continued to gather data to learn more about the actual incidence of ALCL in women with breast implants, the characteristics that might increase the risk of ALCL, and the pathological characteristics and clinical features of ALCL in women with breast implants. Based on information gathered between August 2010 and September 2015, it concluded that women with breast implants may have a very low but increased risk of developing ALCL.

Update

In 2016, the World Health Organization recognised breast implant-associated ALCL as a rare T-cell lymphoma that can develop following breast implants and regulatory bodies issued communications on ALCL.

The Australian Therapeutic Goods Administration (TGA) has been monitoring the link between breast implants and ALCL. It has been working with the FDA and a local expert panel (made up of surgeons, data analysts and cancer researchers) to evaluate the benefits and risks of various breast implants. It has concluded that ALCL linked to breast implants is still rare and is not recommending that women without symptoms have breast implants removed or undergo regular screening. The risk estimate from the TGA expert panel ranges from one in 1000 breast implant recipients, to one in 10,000.

Dr Gazi Hussain, Vice President of the Australian Society of Plastic Surgeons, said that the true incidence and cause of ALCL was not yet known but that surgeons had a working theory: "We think what might be happening is there are potentially issues with technique when inserting breast implants where low amounts of bacteria may be introduced into the patient. That causes low grade inflammation and this inflammation may lead to the development of this type of lymphoma. It's a theory."

Last year French regulators acknowledged the ‘clearly established link’ and the French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.

The FDA advises that the exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global implant sales data. At this time, most data suggests that ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Meanwhile, the UK MHRA is yet to establish the link, although it is looking into the American and French findings. A spokesperson 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.”

Recommendations

The MHRA currently advises no change to current practice and that all patients should be informed that ALCL is a very rare condition. The British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) remains in close communication with the MHRA and, if its advice changes, this will be passed on to its members as soon as possible. BAPRAS maintains that until further evidence is presented there is no need to routinely remove breast implants as a matter of course.

Currently, surgeons are told to be aware that most confirmed cases of ALCL have occurred in women with textured breast implants. ALCL has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.

If ALCL is suspected, a patient should be referred to an appropriate specialist for evaluation. Fresh seroma fluid and representative portions of the capsule must be sent for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.

Patients are encouraged to educate themselves about breast implants before agreeing to surgery, including the benefits and risks of textured-surface versus smooth-surface implants. They are advised that there is no need to change their routine medical care and follow-up, but that they should contact their surgeon or GP promptly should they notice any changes. Patients should be aware that symptoms of ALCL, such as pain, lumps, swelling or differences between breasts, can occur as late as eight to nine years after surgery.

Reporting requirements

There is a strong need for more robust and prospectively collected data to enable better understanding of the incidence, pathogenesis and outcomes for patients diagnosed with ALCL. Any new cases of ALCL should be discussed at a Breast MDT and Haematology MDT. They must be reported to the MHRA as per its ALCL alert in 2011.

In the UK, the recently launched Breast and Cosmetic Implant Registry (BIR) also affords opportunities for registering cases of ALCL. The BIR was primarily designed to record the details of individuals who have breast implant surgery for any reason so that they can be traced in the event of a product recall or other safety concern relating to a specific type of implant. It requires explicit patient consent.

Those affected may also wish to register their case with the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE), a registry launched in the US several years ago in conjunction with the FDA.

Issues arising in clinical negligence claims

Over the last year, Penningtons Manches has been approached for advice by a number of people on claims concerning breast implant associated ALCL. Elise Bevan, a senior associate in the clinical negligence team, comments: “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. In light of the increased reported incidence, we believe that surgeons and patients should be vigilant when it comes to spotting the early warning signs and that they should then follow the guidance that has been issued by the MHRA and other professional organisations.

“Currently, we do not consider there to be any product liability issues concerning the breast implants themselves. The areas of concern that do arise relate to the clinical management of the patient by the surgeon, in terms of providing information regarding ALCL before surgery; suspecting ALCL when presented with relevant symptoms; referring the patient to the appropriate experts; and ensuring the correct tests are done.

“Informal surveys suggest that up to three quarters of surgeons do not discuss ALCL when obtaining informed consent for breast implant procedures. This is likely to be in part due to the difficulty in determining an accurate assessment of the risk. Following the case of Montgomery v Lanarkshire Health Board and the change to informed consent, there is now a greater responsibility on surgeons to ensure that their patients are aware of any ‘material risks’ involved in a proposed treatment. Most surgeons would consider that ALCL is a material risk and, therefore, as part of the consent process, it is strongly encouraged that patients should be made aware of the existence of the risk, the common presenting symptoms and what to do should these occur.

“The most frequent issue that arises is a delay in spotting the signs and symptoms of possible ALCL. While one would not expect surgeons to make a diagnosis themselves, they should be aware of the warning signs and make a referral to an expert who is able to make a diagnosis. It is clear from the evidence that early diagnosis and treatment leads to a better prognosis. The more common symptoms include a spontaneous fluid collection in the breast, developing many months or years after receiving a breast implant, and redness and swelling of the breast around an implant that is not from an infection. Other less common symptoms are tenderness and contraction of the scar tissue capsule surrounding the breast implant. If left untreated, patients can develop a firm distinct mass in their breast. We are seeing cases where patients present with recurring seroma on a number of occasions before the surgeon eventually makes a referral to another expert or sends the fluid off for analysis.

“The second most frequent issue that we see is incorrect testing on the samples taken. The seroma fluid that is drained should be sent for cytological examination which should include immunocytochemical evaluation of cells present with ALCL markers such as CD30. These are specialist tests and must be requested as standard testing will not reveal ALCL. Tissue biopsies should also be subjected to relevant immunocytochemical analysis. If these tests are not carried out, this would be contrary to the advice given by the MHRA and also supported by professional organisations such as BAPRAS. This could lead to a missed diagnosis.

"The whole ALCL issue really highlights the importance of monitoring long-term outcomes for breast implants. We will continue to report on significant findings as new information and analyses become available.”


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