At least 61 women in the UK have been diagnosed with a potentially fatal cancer linked to breast implants, but the type they received continues to be used, with no plans by the regulator to follow France and Australia in banning them.
Lawyers for more than 40 of the women, who are bringing legal action against the manufacturers as well as the clinics and doctors who carried out the surgery, say the textured implants linked to anaplastic large cell lymphoma (ALCL) should be withdrawn from the market. Smooth implants are available instead, which have no proven connection to the cancer of the white blood cells.
The Medicines and Healthcare Products Regulatory Agency (MHRA) says the disease is very rare, but Sarah Moore, a solicitor at Leigh Day law firm, believes there are more cases than the regulator is aware of. “I think there has been misdiagnosis and under-diagnosis, and I think we have to bear in mind that in the last 18 months there have been 17 more reported cases of ALCL,” she said.
“There is now greater patient awareness and as a result, I think women are pushing for diagnosis. I think we’re going to see a significant increase in diagnosis, unfortunately.”
The leading manufacturer of textured implants, Allergan, has withdrawn them from worldwide sale. In December 2018 its European kitemark for the implants expired – the French agency that had granted certification had asked for extra safety data that the company said it could not provide in time. They have not been on sale in Europe since then. The US authorities asked the company to recall its textured implants in July 2019 and Allergan took them off the market.
France and Australia have since banned the sales of all textured implants, although neither has suggested that women should actively seek to have them removed.
In the UK, other brands of textured implants are still in use. Neither NHS England, the NHS Business Services Authority nor the MHRA could say how many had been given to women in the NHS after a mastectomy for breast cancer.
The MHRA says women should be counselled about the risk of breast implant-associated (BIA) ALCL, but it says the chances of having to undergo revision surgery are higher with smooth implants.
“We understand the concern that some individuals may have about this very rare disease. Research is ongoing in the UK and worldwide to better understand how BIA-ALCL develops,” said an MHRA spokesperson.
“Based on our analysis of the latest scientific evidence and expert clinical input, our advice remains unchanged: there is no new evidence of an increased risk to patients and there is no need for people with breast implants to have them removed in the absence of any symptoms.”
Moore says the MHRA’s position is worrying. “It is deeply concerning that the MHRA continues to adopt a ‘keep calm and carry on’ position when it comes to BIA-ALCL,” she said. “We are continuing to be approached by women who have been diagnosed in the last year and who have had to battle to get that diagnosis and appropriate treatment.”
Her clients were motivated by anger and a sense of justice, she said. None was given any warning, even those who had surgery as late as 2016, when the World Health Organization published guidance on the link with cancer.
“They were never told there were these risks involved and they feel incredibly angry. They have had a product which is supposed to be life-enhancing and yet it has caused them to suffer potentially life-threatening cancer.”
Prof Fabio di Pompeo Santanelli, chair of plastic surgery at the University Sapienza of Rome, has been sounding the alarm about BIA-ALCL since 2011, he said. In October he and a US expert, Dr Mark Clemens, convened the first world forum on the disease.
Santanelli presented data for the number of women affected in Europe, showing 287 diagnosed cases so far and 11 deaths. He believes doctors should feel morally obliged not to use textured implants.
“Do you agree you can implant something for cosmetic reasons – because breast augmentation and breast reconstruction are cosmetic procedures? Are you allowed to risk giving someone lymphoma for a cosmetic reason? In my view, no – not a single one,” he said.
BIA-ALCL causes fluid to build up around the breast and can cause lumps, swelling and pain. Caught early, it can be easily treated by removal of the implant and the scar tissue around it. If it is not, it may spread.
Moore believes the UK should ban all textured implants and that there needs to be far better regulation of the cosmetic surgery industry. “The cosmetic surgery market is just rife with cowboys. It’s rife with poor regulation and it preys on quite a vulnerable sector of society,” Moore said.
“It seems to me that this cancer is a rather grim but logical sequela of leaving an industry unregulated for so long.”
The MHRA spokesman said it was “working closely with clinical stakeholders to raise awareness of this rare disease” and pointed to information on its website.
“Clinicians are reminded of the importance of reporting to us any cases of ALCL in their patients who have, or had, breast implants via our yellow card scheme. This information will help us build a more accurate picture of the occurrence of this rare disease,” he said.
Carla Wilson, 37, had never heard of a blood cancer linked to breast implants when she decided, after much research, to have surgery in 2012. She was given the standard warnings about infection and other minor risks. But even though the medical regulator knew in 2011 that textured implants had been linked to a kind of lymphoma, none of the three separate surgeons she saw mentioned it.
The swelling in her right breast four years afterwards, in December 2016, was nothing to worry about, said her surgeon. “He basically said to me, ‘You have probably pulled something at the gym.’ He said to have a hot bath and some ibuprofen and sent me on my way,” she said. But the swelling kept coming back.
She saw her GP. “She actually said, ‘This is cosmetic surgery – you should go and see your surgeon,’ but the vibe I got was that she was very judgmental about the fact that I’d had surgery,” said Wilson.
By then, the MHRA had sent letters to doctors warning about BIA-ALCL. But nobody was looking for it, and if Wilson had not been a persistent self-advocate, she said, “Who knows what would have happened?”
Wilson had been given a textured implant made by Nagor, which is still on the market in the UK. When emails to her surgeon received no response, she contacted the clinic. Another surgeon, who ran it, invited her in and realised the swelling needed urgent attention. He advised that a build-up of fluid should be drained and the implants be replaced – but she would have to self-fund the surgery, which cost several thousand pounds. Luckily, she said, she could raise the money.
“Without that, I could have gone on for another six to 12 months, and who knows what could have happened? It doesn’t bear thinking about,” she said.
After the operation, she expected to be given the all-clear. Instead, she was asked to sit down. Tests on the fluid had come back as “highly suspicious” of the blood cancer ALCL. “It was a bit of a smack in the face. It had never even been on the table before,” she said.
The implants then had to be removed in a third operation, along with the scar tissue that forms around them inside the breast. This time, the GP was sympathetic. Wilson was referred to an NHS breast care consultant and then into the private sector because she had medical insurance.
“I wasn’t allowed any kind of reconstruction, which is difficult for a woman in her early 30s. What I was left with was a mess,” she said. “It affected me a lot as a person. I got very depressed. I lost confidence. It was affecting my job because I wasn’t able to work properly through the surgeries. It was a really difficult time.”
In a recurrence 12 months later, her breast swelled up again. “I was kind of numb. You go on autopilot. I’d been told it wouldn’t come back,” Wilson said. “I thought it must be a complication. Something normal.”
But it was ALCL again, and within days she was in the operating theatre for the fourth time. And finding herself by now a better-informed patient about this rare disease, she spent stressful weeks arguing that the evidence indicated that neither chemotherapy nor radiotherapy would benefit her.
“So far I have remained in remission,” Wilson said. “But this is something I’m going to have to live with for the rest of my life.”
Nevertheless, she said, “I’m one of the lucky ones. I’m quite active in advocacy circles. People die from this.”