No Bra Day 2022: CSA Breast Implant Safety Update
I have had breast augmentation and can only imagine how much breast reconstruction means to women following breast cancer or preventative mastectomy. Breast implants change lives. Breast augmentation done for cosmetic reasons can help increase self esteem and overcome past trauma. Breast implants also play a key element in many breast reconstruction procedures.
Two organizations I support, the Plastic Surgery Foundation (PSF) and the American Society of Plastic Surgeons (ASPS) are sponsoring an amazing Breast Reconstruction Awareness campaign that I want to publicize today.The Close the Loop 5K 2022 NO SWEAT CHALLENGE (NSC) is a fantastic way to support this campaign, raise money and spread the word. First you need to register as a 5K participant and connect your social media accounts (it’s easy)!
Then all you need to do is tweet #BRADay or add hashtag #BRADay to your Instagram posts or you can donate through my page.
The mission behind this campaign mirrors mine, with the aim of educating, engaging and empowering women to choose the procedure that will give the highest chance of optimal results, with realistic expectations. To make this as simple as possible I am providing a review of new data and communications from the FDA, MHRA and BAAPS, regarding breast implant related disorders.
FDA Safety Communication
There have been new Reports submitted to the FDA, since September 1st 2022 regarding breast implants and cases of cancer. The reports submitted to the FDA report two types of cancer that have been found in the scar tissue capsules surrounding breast implants.
There have been 10 medical device reports (MDRs) about squamous cell carcinoma (SCC) , a common type of skin cancer and 12 MDRs about various lymphomas, a type of blood cancer. These cases do not relate to and are separate from any cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare T-cell non-Hodgkin lymphoma.
SCC and various lymphomas have been found in the scar capsule around all types of breast implants, including, breast implants with textured and smooth shells, and saline and silicone filled breast implants.
There are cases of diagnosis many years after initial breast augmentation with breast implants and it is important to monitor for:
- Swelling of breasts
- Pain in or around breasts
- lumps in breast, neck, armpit or groin areas
- itchy skin
- red skin
- fatigue
- fever
- night sweats
- unintended weight loss
Symptoms of squamous cell carcinoma (SCC)
- scaly red patches of skin that may crust and bleed
- open sores that bleed or crust and last for weeks
- rough skin
- raised growths with a central depression that may bleed
- growth that looks similar to a wart that crusts and may bleed
British Association Aesthetic and Plastic Surgeons (BAAPS) Statement
Statement on breast implant associated squamous cell carcinomas (BIA-SCC) cancers – 10th September 2022
Very few cases of these cancers have been reported worldwide and as such, there is not enough information available to provide concrete guidance on risk factors or patient management. These cancers are distinct from BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).
Fewer than 20 cases (to date) of BIA-SCC have been reported, on a background of a worldwide population of several tens of millions of women having breast implants. It should be noted that other cases of SCC have been reported in the breast unrelated to breast implants.
Of the cases that have been documented, they presented between 11 and 40-years after the original breast implant surgery. They occurred with both smooth and textured surface implants, and with both silicone and saline filled implants.
Patients reported delayed swelling of the breast (late seroma), pain, redness and often hardness (capsular contracture) of the breast.
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Data Update
Current data on BIA-ALCL and the rate of incidence varies considerably from 1 in 3817 to 1 in 3000 women with breast implants. The Medicines and Healthcare products Regulatory Agency incidence based on confirmed diagnosis of BIA-ALCL, is an occurance of 1 case per 15,000 breast implants sold in the UK.
‘As of April 1, 2022, the Food and Drug Administration (FDA) has received a total of 1,130 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’
Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, FDA
The total number of deaths following a BIA-ALCL diagnosis is 59 as of the 1st of April 2022 Almost all cases have been in the scar tissue capsules, surrounding textured implants or tissue expanders. The highest number of related cases are related to Allergan Biocell textured implants which were withdrawn from the worldwide market on July 24th, 2019.
The majority of diagnosed cases of BIA-ALCL have been related to textured implants, or when tissue expanders, sometimes referred to as expandable implants, have been in place for a long time. BIA-ALCL can occur many years after implant placement, with approximately 50% of BIA-ALCL diagnosis occurring after an average of seven to eight years.
The main symptoms of BIA-ALCL include:
- breast pain
- lumps in breast or armpit
- swelling of breasts
- seromas
- capsular contracture
- change in breast shape
Treatment for BIA-ALCL when diagnosed early, normally only requires removal of the implant and the complete scar capsure, referred to as an en bloc capsulectomy. Diagnosis of BIA-ALCL will normally start with an ultrasound to check for seromas. If a seroma or seromas are found or there is concern about any other symptoms, an MRI might be performed followed by an ultrasound-guided needle aspiration.
The fluid from around the implant is then tested for T-cell markers. Any suspicious enlarged lymph node(s) should undergo a biopsy at the time of the en-bloc capsulectomy. If lymphoma is found in lymph glands, then chemotherapy and radiation may be recommended treatments.
In most cases when there are no signs of BIA-ALCL spreading outside of the implant capsule, immediate reconstruction following an en-bloc capsulectomy, with smooth implants is possible. Another alternative for women who do not want to have implants, is fat transfer, when larger implants have been used, a breast uplift at the time of en-bloc capsulectomy may also be recommended. There is also the option of breast reconstruction with flap reconstruction.
The current advice based on extensive data from the FDA and MHRA is textured implants do not need removal if there are no signs of BIA-ALCL. Widespread consensus among plastic surgeons, hematologists, oncologists and other medical professionals, is that the risk of BIA-ALCL is extremely low. To put it into perspective the risk of developing BIA-ALCL is estimated between 0.04 and 0.001 percent and the risk of breast cancer in a woman with, or without implants is approximately 12.95 percent.
Breast Implant Illness (BII) Update
The current data is inconclusive and the symptoms and conditions that have been linked to BII, can be caused by various other factors.
Symptoms of BII reported include:
- fatigue
- poor concentration
- memory problems (brain fog)
- joint and muscle pain
- anxiety/depression
- hair loss
- weight loss
Although some women report improvement or resolution of symptoms following removal of the implants, the cause of the symptoms and the degree to which they may be related to the implants are unclear at the current time.’ Medical Device Reports for Systemic Symptoms in Women with Breast Implants, FDA
The FDA, MHRA and other health organizations continue to research BII and collate data on symptoms and conditions reported by women with breast implants. Currently BII is not categorized by the World Health Organisation (WHO) as an official disease. However, FDA guidance is that breast implants are provided with a warning which includes ‘Breast implants have been associated with systemic symptoms’.
My Opinion
I have Allergan Biocell textured implants and have decided to keep them due to the very low chance of developing BIA-ALCL. The recent finding relating to BIA-SCC might make it seem that the potential to develop cancer from breast implants is rising. However, it is really important to put both BIA-ALCL and BIA-SCC into perspective. The risk of BIA-ALCL is estimated to be 0.04% or less and with only 20 cases (reported to date) of BIA-SCC the risk is well below 0.0001%. Only you can know if you are going to worry, and no amount of guidance is going to put your mind at rest if you feel concerned about your implants. If you do decide to exchange your implants or remove them completely, I would recommend you find a plastic surgeon who has experience with breast reconstruction.
For more information here are some blogs you might be interested in:
BIA-ALCL En Bloc resection (prophylactic capsulectomy) Breast Implant Removal and Exchange
Breast Reconstruction Surgery: Alternatives to Breast Implants
Breast Augmentation with Fat Grafting
Everything You Need to Know About Breast Lift and Breast Reduction
