Breast implants have been linked to a fatal immune system cancer known as BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). On 24th July 2019, FDA gave a recall notification for Biocell breast implantations produced by Allergan and ordered the manufacturer to withdraw and discontinue their supply within the U.S. market.
Allergan, the breast implant’s manufacturer, was expected to withdraw all tissue extenders and Biocell textured implantations worldwide since BIA-ALCL was associated with them. Reconstructive implantation used in mastectomy was also part of the products that were required to be recalled.
In a newsletter made by the company, they affirmed that all the novel tissue extenders and Biocell textured implantations should not be used by healthcare providers and should return all unused products to them.
Apart from the link between BIA-ALCL and Allergan products global cases, several deaths have been linked to it, as well. After the FDA made an analysis of numerous BIA-ALCL cases, 573 related cases were found, with 33 deaths recorded worldwide. Of the cases, 481 cases were associated with the Allergan breast implant.
Furthermore, 12 people among the 13 recorded deaths were of people with the condition and patients that had used the Allergan implantations. The other twenty deaths were associated with unknown texture identification or manufacturer.
In a statement released by the FDA, they concluded that Allergan’s Biocell textured implantations have an approximate of six times to cause BIA-ALCL, and the continued supply of them within the U.S. would likely lead to severe health effects and death associated with this type of cancer. This statement was backed with the information that they had and the newly submitted data and analysis. If you have BIA-ALCL, get in touch with us at Consumer Alert Now for help in filing a breast implant & cancer lawsuit.
Recalled Allergan Breast Implants
Several Allergan breast implants were recalled. These implants fall under particular brands and specific models. Here is a list of all the Allergan Breast Implants that were recalled.
The Allergan Saline-Filled Natrelle Implants
This type of breast implant was previously considered as Saline-Filled McGhan RTV Mammary Implant with the approval number P990074. The specific models that fall within this brand include the Style 468,163,363 and 168.
The Allergan Silicone-Filled Natrelle Textured Implants
This type of implant was formerly considered as Silicone-Filled Inamed Implants. It was approved under the code P020056, and the specific models that fall under this category include the Style 110, 120, 115, TRL, TRM, TRF, TCL, TCLP, TCX, TSLP, TSL, and TSX.
410 Highly Compatible Skeletal Shaped Filled with Silicone Natrelle Implants
This type of breast implant was approved under the code P040046. The specific models that fall under this brand include Style 410FM, 410MM,410MF, 410FL, 410ML, 410LL, 410LM, 410LF, and 410LX.
Allergan Tissues Expanders
The Allergan tissues expanders that were recalled include the 133 Plus and the 133 Natrelle implants that have suture tabs.
Suspension of Allergan Breast Implant in Canada
On 30th May 2019, an announcement was made by Health Canada over the suspension of Allergan ’s breast implant. They banned macro-textured implants because of the high record of patients with cancer-related to these products.
The macro-textured breast implant accounted for 85% of the 26 BIA-ALCL cases recorded all over the country. The veto resulted from the safety review of breast implants and their link with the condition back in 2017.
Health Canada believed that the likelihood of getting BIA-ALCL was one person in 3,655 compared with one person for every 16,703 people when it comes to the Mentor Siltex implants with micro-texture. The numbers were confirmed by the number of device sales that the manufacturers provide.
Initially, Health Canada had resolved to suspend Allergan’s license unless they could downplay the risks that result from their products. Eventually, the agency found that the response made by the company was insufficient enough to consider the licensing of its products. As a result, Allergan decided to recall all the unused Biocell breast implantations from the Canadian market voluntarily, although they had thoughts to appeal their resolution.
The Link Between Breast Implants and Cancer
Breast implants have been used since the 1800s. They enhance the shape and feel of a person’s breast and are generally characterized by a prosthetic material made out of silicone gel, saline solution, or composite filler.
Miscellaneous materials such as polypropylene string and soy oil have been banned from the U.S and Europe since they are associated with health risks and several complications.
From the data provided by ASPS (American Society of Plastic Surgery), more than four hundred thousand people get breast implants every year within the U.S. About three hundred thousand of all the procedures that people undergo the procedure for cosmetic procedures while the rest consider the method for reconstructive surgeries.
Patients usually undertake cosmetic procedures to improve their appearance using the implants. Based on the information provided by the American Society of Plastic Surgery, breast implants meant for cosmetic cost at an average of $3,824. On the other hand, patients undertake reconstructive surgeries to restore the shape of their breast after undergoing a breast removal procedure, commonly considered as mastectomy.
Unfortunately, the synthetic material utilized in both procedures is associated with the T-cell malignant neoplastic disease commonly considered to be BIA-ALCL. Since the synthetic material is made out of a rubber silicone shell, it has been considered as the primary source of this condition.
Understanding BIA-ALCL
BIA-ALCL can be considered as a form of T-cell malignant neoplastic disease type that is common with people with breast implants. Please note, BIA-ALCL has no similarity with breast cancer, but it’s a form of cancer referred to as non-Hodgkin’s malignant neoplastic disease that has an effect on a patient’s immunity. This type of cancer can affect various body parts, which includes the lymph nodes and the skin. There are suggestions that the use of textured breast implants is the main cause of this condition rather than breast implants with a smooth feeling.
BIA-ALCL Signs and Symptoms
The significant symptom that precedes from BIA-ALCL is resolute pain or swelling at the implant position. The pain usually persists after the breast implant wound has already healed. Patients can easily confuse BIA-ALCL to breast cancer since most of their symptoms are alike. You must contact a healthcare provider if you experience the following symptoms:
- Changing of the shape or size of your breast that cannot be explained
- Unexplained breast swelling
- Dimpling on any breast’s surface
- Breast asymmetry
- Unexplained breast shrinkage
- Changing of the breast’s skin
- Having the nipple turn slightly inverted or inward
- Tenderness of the nipple or thickening on the underarm or close to the breast
- Change of the texture of the skin around the breast
- Abnormal swelling or lump inside the breast
These symptoms might appear to be breast cancer, but cases related to BIA-ALCL usually affect the area around the implant. The effusion fluid can as well swell the breast and make it tender.
BIA-ALCL Diagnosis
Based on the guidelines provided by the National Comprehensive Cancer Network (NCCN), if a doctor suspects the chances of acquiring BIA-ALCL, one should order an ultrasound, imaging, or MRI. In case the results indicate a minimal collection of a fluid or a tumor around the implant, the doctor should take a sample of the fluid. The doctor should draw the fluid using a fine needle aspiration, which is a type of needle that is inserted through the skin.
The doctor should treat the fluid with CD30, which is a type of protein that indicates BIA-ALCL when found in a higher amount than average amounts on the lymphoma cells. In case the fluid tests positive for CD30, it should be tested for ALK (anaplastic lymphoma kinase), which is a protein that controls the growth of cells. If the test is negative, this indicates the likelihood of getting BIA-ALCL since lymphoma cells do not make the ALK protein. Once this has been confirmed, the doctor should go ahead to conducting a biopsy of the tissue.
BIA-ALCL Treatment
If your pathology results test positive BIA-ALCL, theNational Comprehensive Cancer Network outlines that surgery should be undertaken to remove the implantation and the entire scar tissue capsules surrounding it. The operation is referred to as en bloc capsulectomy, which refers to the removal of the implantation and the scar tissue capsule around it as one piece. The surgeon should remove both implants even if one of them has the infection. Also, any tumors or lymph nodes that are suspicious should be done away with during the surgery.
To some extent, patients might require chemotherapy, stem cell transplant treatment, or radiation, based on the scope of the situation.
BIA-ALCL is a new illness that doctors have no experience in diagnosing or treating. Therefore, there are reports that most patients suffering from this illness do not receive proper treatment when diagnosed with this condition. Anyone with concerns about the kind of treatment that the doctor should undertake, he or she should ask the doctor to consider the NCCN guidelines. Based on every patient’s situation, it is worthwhile seeking care from a cancer center that has a reputation in treating this condition.
Following appropriate treatment and prognosis, studies have concluded that 93% of patients end up being free from the disease three years after undertaking the treatment.
The Effect of BIA-ALCL on Patients
Since some patients receive beast cancer as reconstructive surgery due to mastectomy, it can be devastating to get another diagnosis such as BIA-ALCL. Back in 2017, a profile made about a woman aged 43 years who ended up with a BIA-ALCL diagnosis after she almost lost her life because of breast cancer six years ago was made by the New York Times.
According to a statement that she gave, she had spent six years seeking oncology services four times a year to handle her breast cancer. After winning her battle with cancer, she decided to use an Allergan breast implant and try regaining her normal body appearance and regaining her self-esteem. Unfortunately, the breast implant ended up giving her BIA-ALCL, and she feared that this diagnosis would render her from seeing her children grow up.
Her story gave details about an update of the FDA that outlined the death of nine people due to this condition. At that time, a prediction had been made about the increase of cases since the doctors barely knew the link between BIA-ALCL and breast implants.
Based on the information given by Dr. Clemens, a professional of BIA-ALCL as well as plastic surgery based on the University of Texas, only 30% of plastic medical experts would talk about the likelihood of cancer. The number of surgeons is considered when they are taking their patients through the surgery. With the low number of uninformed patients, the number of augmentation has risen by 37% between 2000 and 2016. Besides that, the number of people seeking reconstruction surgeries due to mastectomy rose by 39% over the same period. Finally, Mentor and Allergan have remained as the largest breast implant makers over this period.
Complications of Health Insurance Concerning BIA-ALCL
According to most health experts, the best way to handle BIA-ALCL is by the removal of the implantation and the scar that surrounds it. They believe that there are chances of having the disease recur and probably get worse if the implant is not removed. This would bring a devastating economic and emotional weight to the victims. Even if such a situation can be covered by health insurance, the life of a patient would be severely impacted due to the likelihood of missing work, recovery time, and the depreciation of life.
Kimra Rogers, a patient from Idaho, had encountered the procedural nightmare that results from the lymphoma assessment. She alludes that her doctor did not have enough information on the relationship between the lymphoma and her breast implant. She underwent radiotherapy and chemotherapy without the removal of the implant.
Blue Cross Blue Shield, which was her insurance, had the will to cover the treatments. Eventually, when it was found out that it was necessary to remove her breast implant, the insurance company refused to cover the costs since they considered that her appeals were exhausted.
According to an issue made by the insurance on the New York Times, they said that anything related to non-medical breast implants is not part of the contract. Therefore, any services associated with breast implants complications, including their removal or reconstructions, does not fall under their coverage. Therefore, Kimra Rogers had to use out-of-pocket expenses to have the breast implant removed.
How FDA has Handled BIA-ALCL
The FDA has given several warnings about breast implant usage. They also have gone to the extent of demanding the manufacturers to describe the dangers related to BIA-ALCL in their product labels.
In a response statement to the people, the FDA stated that the WHO had considered BIA-ALCL as a rare type of T-cell malignant neoplastic disease that has the chance of developing due to breast implants. Also, several data confirmed that breast implantations that have a textured surface have high chances of causing BIA-ALCL instead of the smooth-surface ones.
Furthermore, the FDA stated that patients suffering from a beginning, tenacious pre-implant seroma have a higher risk of the condition. Unfortunately, despite all the conclusions made by the agency, there are accusations that it did not do enough to alert patients about the potential of deadly complications.
In May, the FDA stated that it would help people make a better understanding of the potential risk associated with breast implantations. In March, there was a meeting for two days for the public advisory with patients affected by BIA-ALCL, health experts, stakeholders, and other related experts to talk through the priority of comprehending this type of lymphoma.
According to a statement that they gave, the agency affirmed that they had garnered enough information from the meeting, and it was clear that there was more to be done to protect all women from their decision to undertake breast implants.
It resolved that manufacturers should file medical device statements that can be found in public through the Manufacturer and User Facility Device Experience (MAUDE). It also hoped to put a focus on availing the reports to the people, which would enhance communication within the medical profession, to make it easier and better comprehend and evaluate BIA-ALCL patterns. Therefore, the agency will attempt to reach out to medical experts like dermatologists, internists, pathologists, and gynecologists and raise their awareness of the consequences related to breast implants. FDA acquired a letter that discusses the likelihood of getting BIA-ALCL, providing patients the capacity to call to action if one shows signs of the infection. The agency encouraged health experts to file reports with MedWatch, on information about public safety and reporting programs in adverse situations.
Find Help in Filing Breast and Cancer Lawsuit Near Me
Anyone confirmed to have BIA-ALCL should get compensated for their injuries through a legal suit against the breast implant’s manufacturer. In case you or a loved one has BIA-ALCL, Consumer Alert Now would like to hear more about your situation and help you through your lawsuit. Contact us at 800-511-0747 and let us evaluate your case wherever you are in the U.S. We will speak to you and answer your questions quickly.
