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Textured Breast Implant Illness Causes Recall What to do
Last updated 03/16/2023
In recent years there has been emerging cases over breast implants causing illness. This has led to certain brands and types being recalled. Textured breast implant.
If you haven’t already, learn which device you had placed. Find out if your implant is shown on the list. In conclusion, note any changes to your breast concerning your implant.
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Textured Breast Implants
Textured surface implants first materialized in the 1980s. They have an outer surface that is similar to sandpaper that attaches to the nearby tissue. This keeps the implant from shifting or rotating around in the pocket the surgeon has created.
Further, they can be round, or teardrop shaped and filled with silicone gel or saline (salt water).
For instance, all teardrop shaped breast implants are textured. Due to if the implant were to flip, the breast would look distorted. There is a lower risk of developing capsular contracture with textured implants versus smooth implants.
Capsular contracture happens as scar tissue circling the implant tightens, potentially causing pain and distorting the breast shape.
According to the American Society of Plastic Surgeons this can cause the breast to feel hard and unnatural.
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Augmentation Surgery
Surgeons have chosen to use these textured implant devices in most of their breast surgeries. As a result, the patients’ chest could seem misshaped they say not placing this type of implant.
Many patients are not aware that they can choose where to place their breast implant. This can be either over the pectoral muscle or under the muscle. And there are several factors taken into consideration specifically for you.
These factors are:
- Your body type
- Your current health
- What size (cc's) the actual implants are
- Saline or silicone implants
- Your goals and desires
Textured Breast Implant Dangers
Studies have shown those who received textured implants had an increased risk of cancer. This involves the breast implant associated anaplastic large cell lymphoma (BIA-ALCL). In short, it can be a serious cancer of the immune system different from breast cancer.
Plastic surgeons acknowledged more than 680 cases of BIA-ALCL by February 2019. Most of these patients received the textured implants. On the other hand, at least 24 patients received the smooth surface implant.
What is BIA-ALCL?
According to the Breast Cancer Organization BIA-ALCL is a rare form of T-cell lymphoma. In that cent it is not breast cancer. It occurs in the scar tissue capsule and fluid around the breast implant. However, it can spread past the surgery location.
Symptoms of BIA-ALCL are:
- Breast hardening
- Changes in breast size or shape
- Enlargement of breast
- Fatigue
- Lumps in the breast or armpit
- Pain and/or swelling
- Redness or rashes on the skin
- Unusual weight loss
BIA-ALCL can develop near saline-filled, or silicone gel filled implants. To sum up, these implants are placed during breast reconstruction after mastectomy or cosmetic augmentation (enlargement).
Illness usually develops years after implants are inserted. BIA-ALCL symptoms include persistent swelling or pain around the breast device. Above all, the location should be monitored for any changes.
Surgery is successful in treating most patients with BIA-ALCL. This is to remove the implant and scar tissue around it. In addition, notes the FDA some patients could require radiation, chemotherapy, or both.
Most importantly, if diagnosed early and with the appropriate treatment most patients are curable. But they say a small number have died due to the illness.
This tends to affect only those who have textured surface implants or had them prior.
How do Textured Breast Implants Cause BIA-ALCL?
There is no known cause for BIA-ALCL. One theory with textured implants rough, sandpaper-like surface could cause chronic inflammation in certain patients that leads to lymphoma. And the rough surface along with the greater surface part collects more bacteria producing a biofilm.
Biofilm
A biofilm consists of microbes in a colony sticking to each other and the implant surface. Allergan BIOCELL implants could have more cases due to deeper grooves compared to other textured implant kinds.
Genetic Factors
Possible genetic factors could play a role in the disease. Researchers have found some genetic mutations, JAK1 and STAT3, could increase the risk. Further a possibility in the future is combining genetic testing with HLA testing. In short, this blood test checks the antibodies versus human leukocyte antigens (HLA).
Chronic Inflammation
Studies say that chronic inflammation plays a huge role. Irritation is caused by the implants textured surface to the inner “pocket” created by the surgeon the implant sits in. As a result, scar tissue forms around the implant holding the device in place. So, the cancer cells occur in response to scar tissue circling the device.
It is not exactly clear how this precise pathology causes cancer. But it is known lymphoma attacks the immune system.
Recall for Textured Breast Implants
A warning letter was issued by the FDA on May 14, 2020, to breast implant manufacturers. These were Allergan of CA and Ideal Implant Corporation of TX. The manufacturers failed to go along with regulatory requirements.
No studies were done to determine any potential risks and the safety of the two recalled textured breast implants in 2019. In September 2019 a recall was requested by the FDA of all Allergen BIOCELL and Natrelle textured breast implants.
According to the FDA, this involved women who received Allergen BIOCELL textured breast implants. The letter stated they could be at higher risk for developing a certain kind of cancer from breast implants. Furthermore, this is called breast implant associated anaplastic large cell lymphoma.
An estimate by the FDA says there are hundreds of thousands of women who received these Allergen implants. The manufacturer complied with the FDA’s recall request so the number would minimize those adversely affected by the breast implants.
Breast Implant Cancer Advocates has a list of the recalled Allergan implants here.
Diagnosing BIA-ALCL
Typically, there is first a physical exam. If your doctor should suspect BIA-ALCL imaging with ultrasound or MRI is ordered. When the imaging results reveal additional fluid collection around the implant or a mass a sample should be taken. Further, a fine needle aspiration is used to collect the fluid.
A test is done on the fluid for CD30. This protein shows higher than normal numbers with lymphoma cells, especially in BIA-ALCL. In other words, a positive result for CD30 should also be tested for anaplastic lymphoma kinase (ALK).
These proteins assist in controlling cell growth. Lymphoma cells don’t product ALK protein with BIA-ALCL. So, the test is negative for ALK. Tissue biopsy should be used to examine a mass.
Treatment for BIA-ALCL
Above all, the NCCN suggested if your pathology results indicate BIA-ALCL to have the implant and scar tissue removed. This is to take out the implant and the complete surrounding scar tissue capsule (en bloc capsulectomy). Both implants should be removed no matter if just one is affected by BIA-ALCL.
The surgery is a more involved procedure compared to regular implant removal. This is due to certain implants encourage inflammation that can increase the chances of occurring cancer. And implants can assist in hiding developing cancers from your immune system.
These should also be removed if any are found during the surgery; masses (tumors) or any complex or skeptical lymph nodes. In addition, some patients have required radiation therapy, chemotherapy and/or stem cell transplant therapy.
Because BIA-ALCL is a fairly new illness many doctors don’t have experience diagnosing and treating it. There have been reports from patients of not receiving appropriate care during their diagnosis and treatment process.
If you have any concerns that you could have BIA-ALCL question your physicians to follow the latest NCCN guidelines. This is on your diagnosis and treatment.
Certainly, viewing your situation you could consider care from a medical team at a large cancer center. If your state allows it at least a virtual consultation can be done. This is a facility that has experience treating BIA-ALCL like MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center.
Prognosis After Treatment
The key is to be diagnosed and treated early. Receiving appropriate and timely treatment has a very good prognosis. According to research 93% of patients have no disease at three years after treatment.
What you can do
The FDA doesn’t think all women, despite the danger, with no symptoms should have their implants removed. Consult your physician with any concerns or questions.
Know the Symptoms of BIA-ALCL
Everyone with breast implants no matter of surface texture or brand should know the symptoms of BIA-ALCL.
Regular Screening Mammograms
In addition, continue your regular screening mammograms according to your physician.
Breast Changes
Be aware of changes in the look and feel around your breast implants. And talk to your provider about any concerns you have.
Brand, Type and Manufacturer
Knowing as much information on the implant you received will be easier for you to track just in case of a recall. For instance, do you know the brand, was it textured, silicone or saline?
Wrapping it up
If you have had a breast implant procedure find out if your device is on the list. The surgeon’s office can be contacted to receive your medical information about which implant was placed. Most importantly, monitor your breast for changes and know the symptoms of BIA-ALCL. Consult your physician immediately if you have these symptoms or any concerns about your implant.
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Mary is the founder of All About Our Skin. Former esthetician and CPC. Enjoys researching skincare and has been studying our skin for the past fifteen years.
