Irene Kennedy, 49, depicts rare breast implant-associated anaplastic large cell lymphoma
September is going to be a difficult month for Irene Kennedy as she waits to find out if she has accidentally exposed herself to a death sentence.
"I now receive a letter every day inviting me to the first check-up because I had removed my breast implants in February," she says.
"That will tell me if the cancer caused by the implants has spread elsewhere."
It was in January of this year when Irene discovered that she had anaplastic large cell lymphoma (BIA-ALCL) associated with breast implants. It is a rare form of cancer associated with the "structured" silicone breast implants that are inserted into the breast of an estimated 3 percent of all Western women between the ages of 20 and 70 and the most commonly used implant in the UK.
Millions can unknowingly incubate the rare cancer of the lymphatic system that develops on average for seven years.
Irene, a 49-year-old babysitter from Leeds, is one of more than 400 British women who have consulted lawyers about what they believe to be defective products sold to them without warning of the known cancer risk.
If BIA-ALCL is treated early, in most cases this can be eliminated by removing the breast implants as they develop on the surface of the implant.
But a large number of cases are believed to have been missed because women with the symptoms of sudden, dramatic breast swelling and pain had removed their implants without being tested for evidence of cancer cells.
Irene, in the photo, splashed out over the breast augmentation in 2011, but last Christmas her & left breast suddenly swelled up from the side & # 39; of her bra. She is now waiting to find out if the cancer has spread elsewhere
Some experts fear that these women may have left loose cancer cells and that they may subsequently cause cancer in the lymphatic system (which normally removes toxins from the body).
In the UK, the number of confirmed cases of BIA-ALCL increased from 52 to 72 in just one month.
Last month, the Medicines And Healthcare Products Regulatory Agency (MHRA), which monitors the safety of all devices, revealed to Good Health that over the past five years alone it has received nearly 1,600 reports of breast implant problems in women in the UK alone.
The use of textured implants made by market leader Allergan, as well as Nagor, Eurosilicone and Polytech, has been banned in France since April. In July, the Food And Drug Administration, which regulates health safety in the US, asked Allergan to voluntarily withdraw its textured breast implants from the market following reports of 573 BIA-ALCL cases worldwide, including 33 deaths. Similar action has been taken in 38 other countries.
However, the MHRA maintains that there is no cause for concern and has not followed it here. "All breast implants on the market meet the essential requirements of the Medical Device Regulations," said an MHRA spokesperson. "Where necessary, we take appropriate security measures. Patient safety is our top priority. & # 39;
There were 7,745 breast augmentations in the UK last year
Lawyer Sarah Moore of the London firm Leigh Day & Co, who represents the majority of the women affected, disagrees. She says: "The group of women that has emerged so far is the tip of a much larger iceberg, and once consciousness has spread, there will be many more. We are trying to find out more about which brands of breast implants belong to this cancer, but we are being blocked. & # 39;
She insists that the implants be removed from the market and her customers compensate for the damage they think they have caused.
Irene, who is married to Roger, 49, who runs a contract cleaning company and has an 18-year-old son, already decided in 2011 to splash on breast enlargement.
"I just wanted to be a little more curvy," she says. "I was a 34A cup and wanted to feel better about myself." She was delighted with the result. & # 39; But just before Christmas last year, my left breast suddenly swelled out of the side of my bra. It didn't hurt, but I knew something was wrong, so I went to the private plastic surgeon who did the original augmentation. & # 39;
It was devastating news.
Although Irene & # 39; s implants have been removed, she said that it was a constant concern that one of the cells would come outside the affected breast, that she might get a new growth somewhere else
"He examined me and said he thought it was ALCL and that I was urgently seen by an NHS cancer unit," says Irene. "It took about three weeks for me to get the diagnosis."
Detailed scans were performed to assess if the cancer had spread, and Irene and Roger were taken to a consultation room with a specialized Macmillan cancer nurse to discuss the implications of the ALCL diagnosis.
"I realized that I had to tell my son that there was a possibility that I would die and that's when it hit me," says Irene. "I had the surgery to remove the implants on February 20, the day after my 49th birthday. They took out absolutely everything, the implant and the tissue capsule around it.
"It is a constant concern. I was seen by a hematologist after the operation who said that if one of the cells had gone outside the affected breast, I could get a new growth somewhere else. That is always in the back of my mind. & # 39;
Professor Jim Frame, a breast surgeon consultant in Essex who has led criticism of breast implants in Britain, says that structured implants were introduced in the 1990s without any long-term research, because manufacturers believed they would probably remain more anchored in place by scar tissue.
Rare cancer ALCL is linked to the "structured" silicone breast implants inserted into the boxes of an estimated 3 percent of all Western women aged 20 to 70 and the most commonly used implant in the UK. Irene is pictured
Professor Frame says: "We have created a monstrous problem. It has nothing to do with the silicone they are made of – it is the texture that causes the problem and we don't know exactly why.
"We have probably missed many of these cancers because problematic implants have been removed without being tested for ALCL."
A study published in May in the Journal Of Plastic And Reconstructive Surgery by Professor Anand Deva, of Macquarie University in Sydney, Australia, confirmed that textured implants had a "strong link" with ALCL.
Carla Wilson, 37, from Uxbridge, West London, was almost one of those left in the dark. She has had two ALCL attacks, the second in 2018, one year after her implants were removed. She first had Nagor structural implants in 2012 and developed pain and swelling in her right breast just before Christmas 2017.
"I went to my doctor, who was very judgmental," says Carla. "She said," It's not my problem – go see your surgeon. "
She endured the problem for another three months until a rash appeared on her chest. "I went back to my doctor. Her attitude was still that it wasn't her problem if I was stupid enough to undergo cosmetic surgery. She abandoned me. & # 39;
Carla went to another private surgeon who advised to replace the implants. ALCL was not mentioned.
Suzanne Turner, a cellular and molecular pathologist, said no one has ever shown what happens to implants after prolonged periods in the body and the women with them are & # 39; guinea pig & # 39; s & # 39 ;. Irene is pictured
"I got the impression that an implant change was all I needed to solve the problem. I scraped a few thousand pounds for new Nagor implants. Only at the first check-up, a few weeks after the operation, did they announce that I had cancer. & # 39;
This was the summer of 2017. Her implants were removed and no evidence of cancer spread was found at that time. She says: "I did not know what the prognosis was, what the treatment was or that I would die. It was very difficult. I thought of the fact that I had no will. It was life-destroying. & # 39;
The following year she had an inspection every three months.
"I had ALCL back in the summer of 2018, a year after the implants were removed," Carla adds. "The surgeons took a larger margin from the round of the capsule. They could not tell whether part of the original capsule had not been removed or whether the cancer had returned.
"I have just received my latest scan results. Unfortunately, there were some abnormalities in two of my lymph nodes and in my stomach. There is a concern that the lymphoma may have spread, so I have just had ultrasounds and biopsies of my lymph nodes. This will be something that hangs over me for the rest of my life. & # 39;
The MHRA has established the Expert Advisory Group Plastic, Reconstructive And Aesthetic Surgery (PRASEAG), an independent group of experts. Suzanne Turner, a cellular and molecular pathologist at the University of Cambridge, is a member of the group and a leading BIA-ALCL expert.
She says: "No one has ever shown what happens to implants after prolonged periods in the body and what changes in the chemical structure can occur. These ladies are guinea pigs. & # 39;
Last year, a joint statement from three associations of breast surgeons and the MHRA said: "It is essential that all patients considering a breast implant for reconstructive or cosmetic purposes are fully aware of the potential risks of their surgeon. "
An Allergan spokesperson does not comment on ongoing lawsuits, but says: "We continue to support the needs of patients. Allergan is fully committed to investing in and supporting work to better understand and enhance BIA-ALCL. & # 39;
GC Aesthetics, which produces Nagor implants, says: "The safety of our breast implants has been demonstrated by large-scale European studies with ten years of patient follow-up.
& # 39; With more than three million implants sold in 70 countries in the last ten years, the incidence of BIA-ALCL incidence for (our) textured implants is less than 0.0007 percent and 0 percent for smooth GCA implants during the same period.
"The overall risk of BIA-ALCL has been rated as very low in the published literature compared to other relative risks associated with medical procedures and in the context of risk in general."
But Irene has a simple question: "Should these companies continue to sell products that make women sick?"
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