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Information for women diagnosed with breast implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Posted on 6th August 2018

Recognition of the condition

The recognition by mainstream science of breast implant associated anaplastic large cell lymphoma (BIA-ALCL), means cancer is now a recognised and rare complication of breast implants.

The first cases of BIA-ALCL were reported in the USA in 1997.

The World Health Organisation recognised BIA-ALCL as a distinct entity in 2016.

In July 2018, the Medicines and Healthcare products Regulatory Agency published an alert which recognised the condition and called for action by GPs and specialists involved in breast implantation.

A joint statement agreed between the UK Association of Breast Surgeons, the British Association of Aesthetic Plastic Surgeons, the British Association of Plastic, Reconstructive and Aesthetic Surgeons and the MHRA has also been published.

Lack of knowledge in the medical community about BIA-ALCL has led to it being a condition which was not being diagnosed early and commonly mis-diagnosed. It is hoped the recent publicity will reduce the numbers being mis-diagnosed. The numbers of patients diagnosed is however likely to rise, possibly significantly.

How common is breast implant associated cancer?

A scientific paper published in the Journal of Plastic reconstructive surgery in October 2017 found the risk of developing BIA-ALCL was 1 in 3817 cases.

About 10,000 breast augmentation procedures are performed each year in the UK.

Analysis suggests the problem seems to particularly arise where the surface of the implant is textured rather than smooth.

Although small numbers of cases have been reported to date, increased recognition of the condition may cause the rate of diagnosis and overall incidence reported to rise.

Diagnosis

In investigating possible BIA-ALCL, physicians will carry out a number of investigations

The first stage involves an ultrasound or MRI scan in search of the presence of pre-prosthetic fluid.

If such fluid is located then a fine needle is used to draw out some of that fluid for analysis.

The fluid is then tested to ascertain whether there are CD30 proteins contained in the fluid. A positive finding of such proteins confirms the diagnosis of BIA-ALCL.

The average latency period (ie period between implantation and onset of cancer) is about 11 years. It affects both cosmetic and reconstructive implants. It is rarely fatal and chemotherapy and radiotherapy are often unnecessary if the problem is diagnosed early.

Prognosis

Where the disease is found only around the implant, treatment will include removal of the implant. Prognosis is then very good. Chemotherapy and radiotherapy may not be required.

Where the disease has spread beyond the tissue around the implant, more aggressive treatment including chemotherapy and/or radiotherapy may be required.

The overall survival rate for patients is said to be 89% at 5 years.

Legal implications

Recognition of BIA-ALCL has legal implications for patients, doctors and pharmaceutical manufacturers.

The MHRA has now advised doctors to ensure patients are warned of the risks of BIA-ALCL prior to breast implantation.

Many patients having implants since 1997 will be aggrieved for not having been warned of this complication which had been reported in the scientific literature since 1997.

Peter Todd, a product liability specialist and partner in Hodge Jones & Allen LLP solicitors commented :-

“Diagnosis with cancer is a terrible shock and life changing event for anyone. Although the prognosis of BIA-ALCL overall is positive, there will inevitably be some who will receive late diagnosis where the disease has spread, and where the prognosis will be more guarded. It would be wrong of the industry to shrug off these incidents as merely unfortunate accidents, especially where no warning was given to consumers of any such risks. Our no-fault compensation system for defective products should ensure consumers are fairly and fully compensated for such events”

Hodge Jones & Allen LLP offer a free consultation and advice service for anyone diagnosed with BIA-ALCL and who was habitually resident in England or Wales at the time of the implantation.

Please call Peter Todd on 020 7874 8467 or email ptodd@hja.net for specialist legal assistance

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