Breast Implant Cancer Scare
With the EC seeking to update scientific opinions on the safety of breast implants it is important to understand that this breast implant cancer scare is not unfounded. Most patients with breast implant-associated ALCL require proper management which includes capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants.
Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL) and is associated with the breast implant cancer scare. Like all lymphomas, it’s a cancer of the lymphatic system – part of the body’s immune system. It 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.
This may cause:
- a painless swelling in the neck, armpit or groin
- loss of appetite
- tiredness
- night sweats
- high temperatures
- weight loss
- a cough.
Doctors describe ALCL as ALK positive or ALK negative. This depends on whether a protein, called anaplastic lymphoma kinase (ALK), is on the lymphoma cells. ALCL often responds well to chemotherapy and disappears with treatment (remission). But sometimes it can come back and needs further treatment to try and control it.
The EC view of the Breast Implant Cancer Scare
In 2013 the European Commission released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP),which were found to have been manufactured to deficient standards.
The committee is now seeking information on the possible association between breast implants in general (not just PIP Implants) and the rare cancer known as anaplastic large cell lymphoma (ALCL). This has reignited the debate about the breast implant cancer scare.
“The information to date suggests that women with breast implants may have a very low but increased risk of developing ALCL while the rarity of the disease makes it difficult to establish a definite causal relationship,” the committee says.
Nevertheless, there is a link and the extent of that link is what the committee is seeking to establish.
What you need to do if you have a Breast Implant Cancer Scare
If you have a breast implant cancer scare and are concerned that you have ALCL then you need to report this to your GP and be referred to hospital as soon as possible. Implant diagnosis requires fresh seroma fluid to be sent for 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.
The clinician treating you is also encouraged to discuss concerns with haematology and histopathology colleagues so that appropriate specialist diagnostic services can be involved.
When the implant is removed the capsule should be sent for pathological tests to rule out ALCL.
The management of ALCL must be with the involvement of a specialist Lymphoma Multi Disciplinary Team (MDT).
All cases of ALCL must be reported to the MHRA and information should include:
1. Patient age, gender, race/ethnicity.
2. ALCL diagnosis: date of diagnosis, anatomic site of ALCL, whether ALCL was primary in this site and pathologically confirmed
3. Clinical presentation
4. Detailed pathology findings
5. Breast implant exposure: date implanted, brand and type of implant (saline or silicone-filled), type of implant surface (smooth or textured), complications, length of time from implant insertion, and history of subsequent revision surgeries
6. Treatment(s) the patient received
7. Name, contact information and medical specialty of reporter
The practitioner/hospital should keep a secure copy of this information for ease of future audit purposes and in anticipation of a registry of cases.
The MHRA has advised that no change is needed to current practice and despite the breast implant cancer scare patients should be advised that ALCL is a very rare condition.
Dr Victoria Handley, Director of Handley Law and founder of ‘Solicitors for Women‘ stated that
“until further evidence is presented there is no need to remove breast implants as a matter of course. It is important for ladies to be watchful and if you experience any sudden unexplained changes, lumps or swelling you should speak to your GP or surgeon.We are writing to all of our PIP Ladies to advise them on what to look out for and what to do if they have concerns. For example, we are concerned about those who have had lymph nodes removed as a result of silicone leakage. We need to gather knowledge about ALCL and ladies need to report to their healthcare provider and to the MHRA, any side effects or health problems they have encountered as a result of their breast implants”.
“The MHRA Yellow Card scheme allows anyone to report a problem with a medical device or complication. The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them. I would encourage everyone to take part”.
If you have any breast implant cancer scare concerns or want to know more then please contact Dr Handley at vhandley@handleylaw.co.uk or ring 0800 470 2009