Lois Rogers

https://www.dailymail.co.uk/femail/article-6415201/Breast-implants-hidden-cancer-scandal.html

Debbie Grokes bitterly regrets the day youthful insecurity led her to the door of a cosmetic clinic.

‘Looking back on it, it was so silly. I just wasn’t confident about how I looked,’ she says. ‘I was 25. I thought I would feel better about myself if I had breast implants.’

That impulsive decision led to a nightmare health scare that threatened to deprive her two young sons of their mother as she endured cancer, repeated surgery and chemotherapy.

‘I could have died,’ she says. ‘It has been a horrible experience, and I want other women who have had breast implants to know about this danger.’

When news broke in 2011 that Edwige Ligoneche, a 53-year-old French woman from Marseille, had died from anaplastic large cell lymphoma (ALCL), a sinister rare type of cancer associated with the PIP implants, doctors began to investigate what the implants were made of.

Studies quickly showed they were manufactured from an unapproved type of silicone. The French tragedy was followed by the death in June 2012 of a British woman, Susan Grieve, a 40-year-old legal secretary from Musselburgh, East Lothian.

In total, 50,000 other British women who had received PIP implants were warned they could also be at risk of developing cancer as a result of having breast implants.

Many, including Debbie, were offered free replacements by the private cosmetic surgeons who had unwittingly supplied the dangerous PIP devices. She underwent surgery thinking she would no longer be in danger.

Yet it has become clear that other brands among the 240 types of implant approved for cosmetic use can also trigger ALCL, which is not breast cancer. It is a cancer in the immune cells which can be triggered by a breast implant.

When detected early, it can be cured by removing the implant and capsule of scar tissue that forms around it. Some women have needed chemotherapy and radiotherapy.

Three British women have died and a further 54 have had to undergo additional surgery and cancer treatment for breast-implant associated ALCL, according to new data from the Medicines and Healthcare Products Regulatory Agency (MHRA), a body which monitors the safety of medical devices.

Debbie, who has two sons — Alfie, ten, and Charlie, seven — and lives with her husband, Billy, 36, an electrician, thought that was the last she would have to worry about ALCL.

‘I was told the replacement implants were made by a company called Allergan,’ she says. ‘The new, courser-textured implants were put in in May 2012 and the PIP ones were removed.

‘At first, everything was fine. Then, in the summer of 2016, my left breast started to swell when we were on holiday in Ibiza.

‘I tried to contact the company which had put the implants in, but they were always on voicemail.

‘Eventually, in September, I went to another private hospital, where they aspirated the fluid and removed 310ml. They tested me for infection, but not ALCL.’

Almost a year of anxiety followed as Debbie suffered the unspoken prejudice of a National Health Service programmed to deflect unhappy cosmetic surgery victims.

‘My breast repeatedly swelled,’ she says.

‘I went to my GP and was referred to an NHS breast consultant at Basildon Hospital. I was told it was an infection and that the affected implant would have to be removed, but that it would have to be done privately.

‘I went back twice more to have the fluid drained off. Each time it cost £280. As fast as they were draining the fluid, it was coming back and each time there was more.’

By this point, Debbie just wanted to have her implants removed but she couldn’t afford to pay for the operation.

‘I went to another private clinic in Chelmsford,’ she says. My breast was very swollen and I was told I needed a scan, but it was May Bank Holiday weekend, so it was put off.

‘When the private breast consultant did the scans the following week, he said he wouldn’t take me on because I was very high risk. He said I probably had ALCL and should go to A&E at an NHS hospital.

‘So I went to A&E at Basildon and was immediately referred to a breast specialist, who said he would do more tests but it would take two weeks to get the results back.’

Results of the tests were inconclusive. ‘He told me I needed more tests and to come back to see him in three or four weeks,’ Debbie says.

‘When I went back in July, he said he was very sorry, but the results of the tests were positive — I did have ALCL.

‘The next day I was referred for a scan to see if it had spread, which it hadn’t, but I couldn’t wait to get the implants out. I’m married, I’ve got children — my life was at risk.

‘I had the implants removed in August last year. In the end, my uncle offered to pay for the £4,700 operation so it could be speeded up, because the waiting times for the NHS were very long. After the surgery, I was offered chemotherapy to prevent the cancer coming back, and that finished in mid-November last year.

‘I’m clear of the cancer and well now, and I’m fine about how I look. I don’t care about the size of my breasts — I’m happy without implants and I wouldn’t want them anyway.

‘I don’t think women know about this risk. If they did, why would anyone want implants?’

Compared with 36-year-old Vicky Cattell, another PIP survivor, from Kidderminster in Worcestershire, Debbie has been incredibly lucky.

Vicky’s hopes of motherhood have been dashed and she has been left with painful nerve damage to her legs as a result of the chemotherapy she needed after she developed ALCL.

Like Debbie, she had had replacement implants.

‘I went to have the PIP implants replaced for free in 2012 after the high rupture risk was reported, and I had the new, course-textured ones put in,’ she says.

‘I was fine for the next few years, but in 2015 I started getting symptoms like a dust allergy. My nose and eyes just kept running.

‘Then I started to feel quite unwell, and I was tired and depressed. I didn’t know what was the matter with me.’

By February 2016, she had developed neck and shoulder pain and couldn’t sleep.

‘I had to wear my arm in a sling because of it,’ she says. ‘It was like nerve pain in my back. I thought I had hurt my arms exercising,’ she says

‘Within six months, the pain had changed, it was like something was crushing my chest.

‘That went away, and then a month later I found a lump in my neck. Blood tests showed I had inflammatory markers. They said it was an infection caused by a cold.

‘The inflammatory markers stayed raised for the next six weeks. I asked if it was cancer, but the doctor said no.

‘The lumps came and went, and I developed more in my neck. One was under my ear and was pea-sized.

‘I went back to my GP and he referred me to hospital, but by the time I went to see the specialist it had gone down.

‘Then I woke up one Saturday morning and couldn’t move my head. I went to A&E, and was told to see my GP but by the time I did I seemed all right.’

Vicky was referred for scans and ultrasound investigations. In February 2017, a blood cancer specialist finally diagnosed that she had life-threatening stage four lymphoma, but he didn’t know what type it was or what could have caused it.

‘It was pretty devastating,’ she says. ‘I had six cycles of a chemotherapy drug called brentuximab over four to five months. At the end of my treatment, they said there was a 2cm lump left and they wanted to do a stem cell transplant.

‘But they still didn’t know what kind of lymphoma it was.’

Vicky, who works as an accounts director and has lived with her partner for the past ten years, was not prepared to accept such a vague diagnosis.

‘I started reading up online about breast-implant associated ALCL and I emailed the haematologist about it,’ she says.

‘He referred me to another haematologist at the Queen Elizabeth Hospital in Birmingham, who [confirmed] it was related to the implants.’

It was another five months before the cancer was sufficiently under control for the breast implants to be removed.

‘They were finally taken out only in February 2018,’ Vicky says. ‘I had seven more cycles of brentuximab, which has caused terrible neuropathy [nerve damage] in my legs.’

A cancer drug cycle involves the patient taking a dose of the toxic chemotherapy drug which usually kills normal cells alongside the cancerous ones and makes patients feel sick and ill.

Each cycle involves several weeks’ recovery time before a new dose is given.

In Vicky’s case, it caused major toxic side-effects: ‘I had to crawl upstairs on my knees because I couldn’t walk,’ she says. ‘I stopped treatment in June, but although it’s getting better I have lost the feeling in my legs.’

The final blow was the loss of Vicky’s chances of starting a family. ‘We had been planning to have children, but they said the chemo would probably affect my fertility and now I would be too scared to have a baby anyway,’ she says.

‘It was hard to take when I was told I couldn’t have children, but I’m just glad to be alive.’

Mark Marmur, spokesman for Allergan, acknowledged the risk of breast implant-associated ALCL which he said is ‘an uncommon occurrence in the population of patients with textured breast implants’.

He added: ‘Allergan is and has been fully committed to investing in and supporting work to further understanding and awareness of breast implant-associated ALCL. Patients considering breast implants are encouraged to have a comprehensive conversation with their surgeon about all potential risks and benefits, allowing for a fully informed decision.’

A study from the University of Maastricht in Holland estimated that 3 per cent of women aged between 20 and 70 in developed countries now have breast implants of one type or another.

This would mean around 500,000 in Britain.

The precise number is not known because a voluntary register set up after the PIP scandal began collecting names only in October 2016, and has just 20,095 so far.

In the meantime, in the U.S. the Food and Drug Administration (FDA) has said the lymphoma is more likely to occur in women with implants that have a coarse-textured surface — designed to prevent implants moving around after insertion.

Although the cancer can occur in other circumstances, it was previously very rare.

It is not clear whether PIP women and those having more than one set of implants are at an increased risk, or if the risk stems from the increased surface area of the rough implant causing a bacterial inflammation that develops into cancer.

What is known is that the average time between implant insertion and a diagnosis of cancer being made is seven to ten years.

It is scandalous that, unlike the tight regulations surrounding drug ingredients, manufacturers of implanted medical devices are not required to reveal what materials they use.

Dr Suzanne Turner, a Cambridge University expert in cancer tumour biology, says there is an urgent need to find out what breast implants are actually made of. She believes ALCL is caused by an interaction between the body’s immune system, bacteria in the body and specific toxins on the implants.

‘I think lots of women have their implants removed without anyone ever realising they had this cancer,’ she says.

‘Because they don’t disclose what’s in the implants, we just don’t know what ingredient could be causing this effect.

‘The saddest thing is that many of these women have implants because they have lost a breast to cancer. They have these things put in, and then they get a second type of cancer.’ She says women will recover if they are diagnosed early and their implants are rapidly removed, but she has seen other cases like Vicky’s, where aggressive anti-cancer treatment with life-long side-effects has been needed.

‘People need to be aware of the symptoms for the disease to be caught early,’ she says.

‘I have struggled to get funding for this work. One manufacturer was going to fund me but they have withdrawn.

‘I’m dragging bits of money together. At the moment I have one PhD student funded by Cancer Research UK and Wellcome Trust.’

Some breast specialists are demanding that use of all coarse-textured implants is suspended pending more research.

‘I’m not sure surgeons are ever doing the right thing by offering women cosmetic breast implants,’ says Jim Frame, professor of aesthetic plastic surgery at Anglia Ruskin University’s Postgraduate Medical Institute.

‘I think the use of coarse- textured implants should be reconsidered with a view to stopping their use until it can be proved they don’t cause an increased incidence of breast implant-associated ALCL.’

Other experts are demanding implant patients are monitored to ensure there are no signs of developing ALCL. ‘We think all breast implant patients should have annual check-ups,’ says professor Anand Deva, head of cosmetic plastic and reconstructive surgery at Macquarie University, Sydney.

‘We think some types of breast implant may cause ALCL to develop in as many as one in 1,000 patients.

‘There have been at least 16 reported breast implant deaths worldwide, but I think many more are being missed or covered up because of fear of litigation.’

The Medicines and Healthcare Products Regulatory Agency’s spokesman said: ‘Patient safety is our highest priority and we are actively investigating this issue. While we understand the concern, breast implant-associated ALCL remains very rare.’

He said breast implant patients who notice lumps, swellings or distortions in their breasts, necks or armpits, should speak to their surgeon or GP.

He added: ‘Clinicians are reminded of the importance of reporting cases to us. This will help us to build a more accurate picture of the occurrence of this rare disease in association with breast implants.’

Debbie is not convinced that this is enough.

‘I was told there was no knowledge of this disease, but I think they knew about it as long ago as 2005 when I had my first implants put in, and it’s only textured implants that cause it,’ she says.

‘I’ve been told some women have been so damaged they have had to have complete mastectomies.

‘Maybe these implants should be taken off the market, but certainly everyone should be warned about ALCL so they can go in with their eyes open.

‘I would never have had them if I had known about the risk.’