Implants ‘must carry stronger warnings about cancer risk’ | Breast cancer

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Lawyers are calling for stronger warnings on breast implants as government figures show at least 88 women in the UK have been diagnosed with cancer linked to the surgery.

A small number of women who have implants can develop a rare type of lymphoma known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Several types of the implants most commonly associated with the disease – known as textured implants – are banned in France and Australia. The US Food and Drug Administration issued “black box” warnings – its most stringent warnings for drugs and medical devices – in October for breast implants, including their association with BIA-ALCL.

There have been 733 cases of this cancer linked to breast implants reported worldwide and 36 deaths. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provided the figure to the Observer of 88 reports of confirmed cases in BIA-ALCL in UK patients as of 31 October. That includes some cases where the original operation was not in Britain.

The cosmetic surgery industry came under tougher regulatory scrutiny in 2010 after it was found that breast implants manufactured by the French company Poly Implant Prothèse (Pip) had been filled with cheap industrial silicone unauthorised for human use. It was estimated about 50,000 British women had had Pip implants fitted, which had more than double the rupture rate of other implants. A breast implant register was subsequently set up, but it is not mandatory and thousands of women are missing from it.

Carole Roberts, 61, from Derby, had Pip implants fitted at a private London clinic in 2004. They were removed after the scandal emerged and replaced with textured implants at a private hospital in Birmingham in 2012. Seven years later, she was diagnosed with BIA-ALCL.

A defective silicone gel breast implant
Medical device regulations do not require patients to be provided with written warnings of the possible adverse effects of implants. Photograph: Eric Gaillard/Reuters

She said: “I was concerned because I found a lump under my arm. I was diagnosed with BIA-ALCL and was told by the doctors ‘this is not breast cancer, this is down to your implants’. I was in absolute shock. I hadn’t been given any warnings about the risks.”

Roberts recovered after an operation to remove the implants, followed by chemotherapy and radiation treatment. She is now one of eight women represented by legal firm Leigh Day who were diagnosed with BIA-ALCL and are now planning legal action over the alleged product failures of their implants.

Bozena Michalowska Howells, head of product safety and consumer law at Leigh Day, said patients needed to be better informed about the risk. She said: “There should be better warnings and closer follow-up. The breast implant registry should also be mandatory.”

Sarah Moore, a partner at the legal firm Hausfeld who has worked on product liability involving medical devices, said: “Breast implants shouldn’t be seen as an extension of Botox and having your eyebrows done. These are significant surgical interventions and there can be serious problems.” She said prominent warnings on possible side effects should be provided to the patient along similar lines to the “black box” warnings used by the FDA.

Suzanne Turner, professor of cellular and molecular tumour biology at Cambridge University, said the Allergan Biocell textured implant which had been linked to higher rates of BIA-ALCL was voluntarily withdrawn by the manufacturer in July 2019. Out of 733 cases of the cancer identified by the FDA in January 2020, 620 were reported to have involved Allergan products.

Turner, who is investigating whether BIA-ALCL may be linked to chemicals in implants, said regulators should consider withdrawing other textured breast implants. She said: “It should perhaps be the case that we need to understand more about the link between these implants and cancer before we let them be freely used.”

She said patients who had had the implants faced a small risk and were not advised to have them removed. They should contact a doctor if they notice a sudden onset of swelling, a lump, and/or pain.

Nora Nugent, a plastic surgeon and council member of the British Association of Aesthetic Plastic Surgeons (Baaps), said the MHRA was consulting on the regulatory system for medical devices, including implants, which may result in new requirements about advice given to patients. Baaps members are already advised to discuss the risk of BIA-ALCL with patients.

Medical device regulations do not currently require patients to be provided with written warnings of the possible adverse effects of breast implants, but clinicians have a legal obligation to discuss the potential risks with patients.

The MHRA said its consultation proposed a new requirement for information on implants to be provided for patients in leaflet or digital format. A spokesperson said: “This could include a caution that risks may emerge during the use of an implantable device.”

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