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Women take legal action on breast cancer implants

Linsey Bromfield implanted with breast implants in 2005, but later developed implant-associated lymphoma

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Lenzi develops rare lymphoma 13 years after the breast implant surgery

Twenty women in the UK are taking legal action after developing a rare form of breast implants-related cancer.

More than 50 women are diagnosed with the same condition in the UK and hundreds more worldwide.

A top surgeon said there were gaps in implant information and people were almost used as guinea pigs.

One manufacturer has issued a worldwide reminder of some textured implants that are associated with most cases of breast implant lymphoma.

MHRA, the Medicines and Healthcare Products Regulatory Agency, which regulates medical devices in the UK, is currently collecting data on women affected by breast implants associated with anaplastic large cell lymphoma (BIA-ALCL).

He estimated the risk of being one in every 24,000 implants sold (looking at both textured and other types of breast implants).

It is estimated that tens of thousands of breast implant surgeries are carried out in the United Kingdom each year, mainly in private clinics.

"I'm worried I'm going to die"

50-year-old Linsey Bromfield is one of the women who is taking legal action – in her case against the manufacturer.

She paid privately for breast augmentation in 2005 after giving birth to two children, and went from size B to cup D.

Linsey was very pleased with her implants, but 13 years later in 2016, she noticed that her right breast had become so swollen that she could not wear a bra.

She had leaky breast fluid at an NHS hospital and was later diagnosed with implant-associated lymphoma.

"I was crying, I was really crying. I was angry and hurt. At first I couldn't take it. I was worried I was going to die."

"I think when you hear the word 'cancer' you think, will I die?"

Both implants were removed from the lens and it has not been a disease ever since. Other women, however, need further treatment, including chemotherapy.

What Is Lymphoma Implantation?

It is a cancer of the immune system, not a type of breast cancer and is a rare subtype of T-cell non-Hodgkin's lymphoma.

Mr Nigel Mercer, a plastic surgeon and chairman of an advisory group of surgeons who monitor cancer cases for MHRA, said: "The same type of implant has been in existence for 30 years, but it is only now that we have begun to see it as a disease, so it seems that this is a really new disease. "

Cancer cells are usually found near tissue and fluid scar near the implant, but in rare cases they can spread.

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Scientists believe lymphoma may be a reaction to textured implant surface

If caught early, the lymphoma can be cured by removing the implant and the capsule around it.

The cases occurred between three and 14 years after surgery.

Doctors are not sure how BIA-ALCL is caused – but scientists believe it may be a response to the textured implant surface or a bacterial infection.

What Do Surgeons Say?

Linsey's surgeon, Professor James Ram, who works in Chelmsford, Essex, says he was shocked by her case, which is the only one he has seen in 30,000 or more breast surgeries that he has performed.

He says there is insufficient information from surgeons about the potential risks associated with various breast implants.

"There needs to be a more stable information package for those who provide the service. [UK research around this] it's terrible, "he said.

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Prof. Ram was Linsey's surgeon

Prof. Frame believes that insurance packages can be provided to patients who have undergone private surgery to ensure they receive ongoing care.

Mr Mercer says there are many unknowns regarding breast implants and doctors have a moral obligation to say this to patients.

He said that women in the UK were not "properly warned that breast implants were not mandatory for life."

"There are unknowns with every implant, but that means we use our entire population as guinea pigs."

Mr Mercer and Prof Frame call for international collaboration among global clinicians to share breast implant data.

What is the advice for women?

In July, the MHRA issued a joint statement with several of the UK's leading surgeon associations. It said it was "essential" for surgeons to make all patients considering breast implantation for reconstructive or cosmetic purposes fully aware of the potential risks.

The organization also says breast implants undergo a rigorous risk-based approval process before being used by the general public.

Women who have textured implants may not need to remove them, but should consult their doctor if they have any concerns or symptoms.

Removal of implants unnecessarily may carry the risk of additional surgical complications.

What next?

When implants were placed on the lens in 2005, BIA-ALCL was not widely known and neither surgeons nor patients were aware of the risks.

Linsey says the operation may have continued, but believes some women may be delayed in the future.

Women are taking legal action against surgeons and manufacturers. They want reimbursement for implants and their removal, as well as compensation for injuries, disasters and any potential financial loss they have suffered. Pre-action letters are sent to the countries concerned this month.

Their lawyer Zahra Nanji of Lee Day says: "I truly believe that the manufacturers, manufacturers and distributors of these implants should take responsibility."

Manufacturer Allergan said patient safety is a priority and will support informative labeling "to promote and promote the safest use of breast implant products."

"We continue to invest and support work to further understand and raise awareness of BIA-ALCL," the company said.

He has issued a voluntary worldwide seizure of breast saline and silicone implants and silicone fillers.

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