A type of breast implant used by millions of women around the world is under scrutiny after French surgeons were advised to stop using it because of a potential link with a rare kind of cancer.
Textured breast implants have been linked with anaplastic large cell lymphoma (ALCL), which forms in the scar capsule around the implant and normally begins with pain and swelling in the breast.
Women who have the implants and capsules removed can make a full recovery, but if left untreated the disease can spread throughout the body and become life-threatening.
There is growing concern about the effects of the implants, with figures collected by plastic surgeons suggesting there have been at least 615 cases of the disease associated with breast implants, and 16 deaths.
In France, where 85% of the breast implants used in women are textured, the health regulator, ANSM, has recommended surgeons switch to smooth implants while the links are investigated.
ANSM said it would convene a meeting of experts in February to hear from patients, health professionals and other stakeholders, before making a ruling. The situation in France is likely to stir the debate about the implants in other countries.
In the UK, where most of the implants used are textured, there have been 45 confirmed cases of the lymphoma being linked to them, and one fatality. The health regulator estimates the risk at one in 24,000 women with implants.
In the US, 252 cases have been confirmed, but experts believe the true figure to be 800 to 1,000, with many as yet undiagnosed.
Australia’s health watchdog, the Therapeutic Goods Administration, reported 72 cases and has said “expert opinion puts the risk of ALCL at between one in 1,000 and one in 10,000”.
The first report of a link was made in 1997, and the UK’s health regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), put out an alert in 2011 after reports of cases in other countries.
“ALCL is rare, but it is important healthcare professionals and patients who have implants know about it,” the regulator’s most recent update said.
However, several women who have received textured implants since the first alert in 2011 said they were not told about the risk – and an apparent lack of awareness among doctors meant some waited months before getting treatment.
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Carla Wilson, 36, from London, who was diagnosed with ALCL in 2016, three years after receiving her implants, said it was unacceptable. “They’ve known about it for long enough now to warn women about it,” she said. “I could have avoided this.”
Wilson said she was initially told to take hot baths because she might have strained a muscle at the gym.
Another woman, who wished to remain anonymous, was diagnosed more than a year after her symptoms emerged, having first been prescribed physiotherapy for a spinal problem, and then chemotherapy for a different type of cancer, which proved ineffective.
By the time ALCL was considered “there was an 11cm x 8cm mass in my chest and various lymph nodes in my neck were enlarged, the lymphoma had also spread to my heart, I was quite poorly. I was diagnosed at stage four,” she said.
“The doctor wanted to take me into hospital straight away because the nodes were pressing on my trachea and also a main artery; he was concerned I was going to stop breathing over the weekend.”
She only received appropriate treatment after contacting a doctor in the US.
After 13 rounds of immunotherapy, she had surgery to remove the implants. “I had implants simply due to being under-confident. I thought they would make me happy but it was very short-lived.”
Charlie Fouracres, 33, from Essex, was diagnosed after the cancer spread beyond her breast, although in her case doctors were quick to identify ALCL.
She had four rounds of chemotherapy and eight of immunotherapy before going into remission in spring 2016, nine months after noticing a pea-sized lump on her chest. The tumour spanned from her neck to her armpit. “I couldn’t even move my arm, I couldn’t get myself dressed in the morning. It was really painful, it was immobilising,” she said.
Nigel Mercer, a plastic surgeon who chairs the plastic, reconstructive and aesthetic surgery expert advisory group (PRASEAG) for the MHRA, said: “There is no excuse now for a surgeon working in the UK not telling people what the risk is.”
He said the rarity of the illness was perhaps the reason why surgeons were not giving proper warnings. “The committee is asking the MHRA on a regular basis whether this poses a public health risk, and at the moment it doesn’t.”
He advised anyone having implants replaced to have the capsule surrounding them taken out too. “This is where the problem lies,” he said. “You can have women who have had several different implants but the capsule is still there.”
Doctors in the US have been studying the link between ALCL and breast implants for more than 20 years, and have helped provide British women with a diagnosis.
A pioneer of the work, Mark Clemens, an associate professor of plastic surgery at MD Anderson Cancer Center in Houston, said he had never seen a case of ALCL that was not linked with textured implants.
“It is an uncommon disease so when women are deciding on breast implants they need to be aware of the risks and benefits of textured and smooth; they need to be told that it can exist, what the symptoms are and what to do about it.”
Clemens said he did not use any textured implants in his surgery, and that was in line with other surgeons across the US. “There needs to be an established benefit to justify the increased risk. With my patients I don’t see any drawback from smooth implants.”
Paul Harris, the president of the British Association of Aesthetic Plastic Surgeons, said: “What I tell patients is that there is a link between textured implants and BIA [breast implant associated]-ALCL, and that the figure given in the UK is about one in 30,000, but I say some reports suggest the risk is higher than that.
“Some reports have suggested it may be as much as one in 2,500 or one in 3,000 for some textured implants. In the least risky types of textured implants it is lower: one in 50,000 or 60,000.”
Some women admitted the stigma of having breast implants may be preventing others from finding out more.
“I didn’t talk about it to friends and family,” said Wilson. “A lot of women who have BIA-ALCL live in a state of guilt. I felt almost like I’d done it to myself. You don’t feel like a valid cancer patient in the way other cancer patients do, despite never having been warned of the risk of cancer when I made the decision.”
The breast implant maker Allergan said it was “fully committed to investing in and supporting work to further understanding and increasing awareness” of BIA-ALCL and had developed new product labelling as well as funding external research.
“While these efforts to enhance understanding and awareness are ongoing, we continue to support the needs of patients and their surgeons.”
Another maker, Mentor, said it was important for patients to understand the benefits and potential risks of the different types of implants.
“The newest generation of shaped breast implants are textured to reduce movement of the implant. Textured implants have other benefits in reducing complications, which may require reoperation, that occur much more frequently than BIA-ALCL, including capsular contracture.”
‘It was the worst pain I’ve ever had’
It was Deborah Grokes’s husband who first spotted a problem with one of her implants in 2016. “We were on holiday and he said ‘Oh my God, your left breast has swollen’. I hadn’t noticed. I didn’t have any pain,” she says.
Her textured implants had been put in four years earlier as replacements for some made by the French manufacturer PIP, which was found to have used dangerous silicone in its products.
Grokes went to a private hospital for a checkup. “They aspirated my breast – they took out 310 millilitres of fluid – about the same as a can of Coke, and it looked normal again. But six weeks later it was back to the same size.”
After two more aspirations she went to her GP. “I’d had them put in privately so I thought my doctor wouldn’t help – I had this idea that I needed to sort it out myself.”
Her GP was sympathetic and referred her to a hospital, which prescribed antibiotics.
She turned to another private clinic and eventually a plastic surgeon suggested she might have a lymphoma. “She sent me an email explaining it all, which I could show to my doctor. At the end it had the word lymphoma – I knew a bit about cancer and my first thought was: ‘Oh my God, I’m going to die’.”
Grokes went back to the NHS and a different surgeon. She says he told her he had never heard of ALCL, and thought it was unlikely she had it but would do tests.
Two weeks later he said he would remove the implants and do a biopsy on the capsule that had formed around them.
Grokes felt better as soon as they were removed, and took along her young sons to what she thought would be a routine checkup a few weeks later. “He examined me and then said: ‘I’m really sorry, but you have BIA-ALCL’.”
After further tests she was back on the operating table to have the capsules removed. “It was so painful. I’ve had implants twice, I’ve had two natural births, and it was the worst pain I’ve had.”
She was given the all-clear after the operation, but had chemotherapy to ensure the cancer was gone. Months later she feels much better, but worries the cancer could return.
She cannot recall any discussion about the pros and cons of the implants before she had the operation six years ago. “I was not told they were textured. I wasn’t told about ALCL … it didn’t come into conversation even though I know now that there was a case back in the 1990s – it was known about when I had the implants.”
