Britain's breast implant scandal: Channel 4 Dispatches

24 June 2019

Monday 24th June, 8pm, Channel 4

Dispatches investigates the true impact of breast implants, whether some women’s implants are making them ill, and reveals that over 250 women are preparing to bring a class action over possible links to breast cancer. 

This Dispatches investigation has also persuaded the medical regulator (MHRA) to rethink their stance on the acknowledgement of the illness.

• “I think it's entirely reasonable that book should be opened again now, and we and our advisory group are already looking at the evidence around this and we would be eager to learn more from patients, particularly about their experiences in this area,” MHRA
• Breast Implant Illness is now listed on the American regulator’s website under ‘risks and complications’ for breast implants. That’s not the case in the UK.

Breast Implant Illness:

For decades a small but vocal number of women have complained of breast implant illness, but the medical profession could find no evidence to link their symptoms to their implants.

Symptoms associated with what is referred to as Breast Implant Illness vary but can include; choking, heart palpitations, brain fog, rashes, hair loss, joint pain, anxiety, depression.

Presenter Abbie Eastwood had breast implants put in when she was 25, “My hair fell out, I had memory fog, aches and pains, utter exhaustion. I had to stop work. I spent whole days in bed.” After her Doctors told her she had rheumatoid arthritis she found an American website, hosting 70,000 women with the same symptoms and realised it could be her implants.  

But this year, the American regulator, The Food and Drug Administration (FDA) changed its stance and said, “while the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed.” And that they are “taking steps to better characterise the condition and its risk factors.”

Azhar Aslam, a private surgeon working on Harley Street, discusses the results of the 3,000 explants he has performed. “Anecdotally almost everyone said they were feeling better. Almost everyone who I did then and even patients we are doing now, they say they feel better.”

An NHS spokesperson said: “While there isn’t currently any clinical evidence that these symptoms represent a new kind of illness, women experiencing them should seek advice from their GP at the earliest opportunity.”

Implants Banned in France still in circulation in the UK:

In April this year, the French regulator banned a particular type of implant, made by six manufacturers, as a precautionary measure. The implants banned have a highly textured shell known as a macro textured shell.

Two of the brands, whose highly textured implants are banned in France, are popular in Britain: Nagor and Allergan. Nagor’s implants are still on sale in the UK, to private clinics and the NHS. But Britain’s most popular implant range, Allergan’s Biocell, has had its license suspended and the products have been recalled.

Nagor says it is “extremely surprised with the decision taken by the French regulator” and the decision “went against the recommendation of its own scientific committee.” Nagor told us there’ve been no reported cases of breast implant cancer linked to their implants in France.

The MHRA has known about the Breast Implant related cancer since 2011, but it has only recently come to public attention.

Abbie, “Would you say that breast implant related cancer is under-diagnosed in the UK?

MHRA, “Because it’s an evolving diagnosis, the WHO only classified it as a condition fairly recently, it’s reasonable to assess that it probably is underdiagnosed. We’ve consistently been communicating with the medical community, we’ve put out several medical alerts, we’ve been working with the professional bodies to increase awareness of this condition. Our focus is on the professionals to improve their knowledge and understanding of this evolving condition.

Scientists don’t know what’s causing the cancer. Current thinking is it could be toxins in the gel and shell, the abrasiveness of the shell, or bacterial contamination during surgery but research is ongoing to determine the implications of different surface textures.

Allergan responded, “The safety of Allergan’s implants is supported by extensive pre-clinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies. The benefit/ risk profile of textured implants is positive. As with all Allergan products, the company is committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards.”

MHRA response:

The British regulator says there is no need for women to remove their implants based on current evidence.

MHRA say, “we’ve been working extensively with the best expert input that we can get to establish the facts around the safety and performance of these devices and at this stage we have no reason to believe they should be taken off the market. We reckon that something around in excess of a million implants have been placed in the UK - breast implants - over time.  That's a number increasing rapidly all the time. Over all of that  time we’ve had 57 reports of breast implant related ALCL.”

Nagor says its implants “are designed and tested to meet all applicable international standard and regulations supported by clinical data which demonstrates their long-term safety and performance.” And that it supports the “work done by regulators to better understand any associated risk factors to ensure women have all the information needed to make best-informed decisions.”

Case Study – Julie:

Julie Harris used to work in the cosmetic industry selling Allergan breast implants, in 2012 she had Allergan Biocell implants. Nine months after the implants were put in her left breast began to swell. She had the fluid drained, but it kept filling and after extensive tests Julie was told she had advanced breast implant related cancer. It had taken two and a half years to diagnose.

Julie has had 6 cycles of chemotherapy. She wrote to Allergan and two weeks ago was offered just under £4,000 for ‘out of pocket expenses.’ Julie is now taking legal action, alongside 250 other women.

Case Study – Kathryn:

Kathryn Hewitson is one of thousands of women in the UK to have breast implants after surviving breast cancer. She was recommended a mastectomy and immediate reconstruction, she now believes she has Breast Implant Illness.

She suffered from fatigue, pain, poor concentration and brain fog. But after surviving cancer and still in remission she found it hard to persuade her doctors to take her concerns about breast implant illness seriously.

BRITAIN’S BREAST IMPLANT SCANDAL: DISPATCHES. MONDAY 24th JUNE, 8pm, CHANNEL 4

Executive Producer: Karen Edwards

Prod/Dir: Esther Oxford

Presenter: Abbie Eastwood

Production Company: Blakeway Productions