Textured breast implants manufactured by Allergan were withdrawn from the European market in December 2018 after a small number of women were found to have developed a rare type of blood cancer called Anaplastic Large Cell Lymphoma (ALCL).
According to Macmillan Cancer Support, ALCL develops when white blood cells (T-cells) become abnormal and build up in the lymph nodes, usually in the form of scar tissue, which then develops around the implants and can spread to other parts of the body.
The two most common symptoms include late onset of seroma (a collection of fluid around the breast) which results in breast swelling, and the development of a breast mass (lump) which can form next to the implant or within the fibrous tissue around the implant. These symptoms can develop at any time following surgery but usually occur more than a year after surgery.
The Medicines & Healthcare products Regulatory Agency (MHRA) is an agency of the Department of Health and Social Care in the UK. It is responsible for ensuring that medicines and health care products are safe for patients. In December 2018, MHRA published a statement on ALCL and breast implants in which they advised: “there is no need for people who have Allergan breast implants to get them removed or to have additional clinical follow up”.
“there is no need for people who have Allergan breast implants to get them removed or to have additional clinical follow up”.
Measures need to be put in place, at least in the interim, to ensure women with these types of implants are closely monitored for any symptoms suggestive of ALCL. Additional surveillance may assist in providing early detection and prompt treatment. Women with Allergan implants are likely to suffer ongoing anxiety as to whether they are at risk and those who have been diagnosed and treated will have fears over whether the cancer will return.
It has been reported that curative treatments are available if the cancer is identified and treated at an early stage. Inevitably, delays in diagnosis can make treatment more difficult and may result in the need for radiotherapy and/or chemotherapy. However, should MHRA be doing more? Should the manufacturer be doing more to assist with monitoring and be required to fund treatment costs for any women affected?
The primary concerns relate to whether these women had been consented appropriately with regards to the risks of textured breast implants. The widely reported case of Montgomery v Lanarkshire Health Board in 2015 reaffirmed the position in this area of law, namely that clinicians are under a duty to take reasonable care to ensure that a patient is fully aware of any material risks in any recommended treatment to enable them to make an informed decision. Despite ALCL being a rare form of cancer, it is certainly arguable that patients would be likely to attach significance to the risk.
Women who have had an Allergan textured implant should get in touch with a solicitor to seek further advice. Clinical negligence claims being pursued are likely to be against the private medical consultant (if the procedure was carried out at a private hospital) or a hospital trust (if the procedure was done under the NHS). A product liability or breach of contract claim may also investigated at the same time against the manufacturer and/or UK distributor.
Maryam Abdullah, a solicitor in the clinical negligence team at Lime Solicitors
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