Breast Implant Illness is becoming more Common. Here’s what you Should Know

breast implant illness

breast implant illnessNew York City, NY

Dr. B. Aviva Preminger first made you aware of BIA-ALCL last year. Standing for breast implant-associated anaplastic large cell lymphoma, this type of cancer attacks the immune system. Also known as Breast Implant Illness or BII, BIA-ALCL forms in the scar tissue and/or fluid that surround the implant. For years, BIA-ALCL has been described as a rare form of cancer. However, recent statistics and reports indicate this type of lymphoma is becoming more common. Dr. Preminger wants you to understand the risks of BIA-ALCL, and how it might impact you.

A Disturbing Trend

In December, the Canadian Broadcasting Corporation issued a report noting a significant increase in the number of confirmed and suspected cases of BIA-ALCL. The statistical trend is disturbing, to say the least. Health Canada told the CBC it received 106 reports of BIA-ALCL—with 52 of those reports coming since May 29 of last year. Those seem like small numbers until you consider this. Prior to May of 2019, Health Canada had received just 26 reports of this form of lymphoma.

Even before the recent uptick in reports in the latter half of 2019, Health Canada took action in May to ban BIOCELL® macro textured breast implants made by Allergan, citing the increased risk of BIA-ALCL from those implants as the reason. Last summer, Allergan voluntarily recalled all BIOCELL® textured implants. The Food and Drug Administration (FDA) classified the Allergan announcement as a Class I recall, meaning that the use of the devices carried with it a risk of serious injury and/or death.

In a statement providing their basis for the recall, the FDA noted the risk of BIA-ALCL with Allergan BIOCELL® textured implants was six times higher than normal. FDA statistics also noted that nearly 84 percent (481 of 573) of all reported BIA-ALCL cases worldwide involved patients with Allergan textured implants at the time they were diagnosed. The FDA also first identified a possible link between implants and ALCL nearly a decade ago—in 2011, to be precise. The World Health Organization also has recognized the threat of BIA-ALCL, first doing so in 2016 by recognizing ALCL as a unique form of lymphoma that develops after implementation of the breast implants.

As more data has been gathered, the rate of discovery continues to change. The CBC reported that, as of last May, one in every 3,500 patients had a risk of contracting BIA-ALCL. However, there is a growing concern that the prevalence of BIA-ALCL is far more widespread than statistical data indicates. One research study completed in March of 2019 determined the risk of BIA-ALCL was one in every 2,582 patients—well below the CBC estimates.

Reconstructive breast surgeons around the world have growing concerns about their patient’s safety, especially as it relates to breast implant illness. Some doctors have discovered that BIA-ALCL was more prevalent than indicated by current official statistics. This creates another indicator of the growing concern of the medical profession at the danger of this form of lymphoma.

Another attendee of the conference was Terri McGregor, who underwent eight rounds of chemotherapy to treat her BIA-ALCL following her diagnosis in 2015. A native of Ontario, McGregor warned against continuing to describe this cancer as rare, based on her personal experience. Specifically, she noted, presenting symptoms to a physician had a greater likelihood of being dismissed since cases BIA-ALCL are not considered common. This case, in particular, capitalizes on the importance of knowing the signs and symptoms of breast implant illness, and discussing these concerns with you physician.

Get the Facts on BIA-ALCL  

Based on this information and the growing number of breast implant illness cases, Preminger Plastic Surgery wants to make sure our patients have all the knowledge they need to make informed decisions about getting breast implants or implant removal. If you have received breast implants of any kind but especially textured implants, you should be aware of the warning signs of BIA-ALCL. These symptoms usually manifest during the early stage of cancer.

They include:

  • Pain or swelling in the breasts
  • The appearance of asymmetrical breasts even after receiving implants
  • Detecting a lump or palpable mass in the breast
  • Swelling in the lymph nodes
  • Skin rash
  • Fatigue

If you identify any combination of these symptoms, seek the care of your doctor as soon as possible. Remember that these symptoms could manifest well past the installation of the implants. The current average time before BIA-ALCL manifests is approximately 10 years after the placement of breast implants.

Remember, BIA-ALCL is not breast cancer. Instead, it is a lymphoma—a type of cancer that targets the immune system. BIA-ALCL develops in the fibrous scar capsule of the implant, not the implant itself. The type of material used to fill the implant has no impact on the likelihood of developing BIA-ALCL, according to the FDA, although the organization cited a lack of sufficient data in making that statement.

How to Protect Yourself

Your best defense is knowledge. Be aware of the symptoms of BIA-ALCL, as listed above. If you experience any combination of these symptoms, contact your physician to schedule an evaluation. This evaluation should entail a physical exam, in combination with diagnostic imaging and examining the fluid and tissue surrounding the implant. You also should keep some sort of record of the device manufacturer and model name of your implant. If you do not presently have this information, you should be able to obtain it from your surgeon or from the facility where the operation was completed. 

Any patient with a confirmed case of BIA-ALCL should have their implants removed as soon as possible. The surrounding scar capsule also should be removed, making this a more involved surgical procedure than a typical implant removal surgery.

What’s Being Done

At Preminger Plastic Surgery, Dr. Preminger and her team of professionals follow FDA-recommended protocols when dealing with cases of BIA-ALCL. This entails the following steps:

Reporting each case to MedWatch

Submitting case reports to the PROFILE Registry 

This will help aid the FDA’s continued efforts to gather information and data on BIA-ALCL, a process that includes a summary of incoming medical device reports, a review of the latest medical literature, and keeping aware of adverse events due to other real-world data. To help, the FDA launched the Breast Implant Registry (or NBIR) in the fall of 2018, intending it to be a hub of information on all breast implants used and produced in the United States, while also tracking the performance of those implants as time progresses.

Our Breast Implant Policies and Procedures

At Preminger Plastic Surgery, we no longer offer textured breast implants. We recognize the threat of BIA-ALCL. If you have implants of this type, Dr. Preminger invites you for a consultation to discuss your options. Breast implant removal or exchange may be an option for you.  Dr. Preminger offers IDEAL implants, Gummy Bear implants, or smooth implants filled with saline or silicone. We also can perform a partial or complete removal of the scar capsule surrounding the implant, which is the tissue where BIA-ALCL is most likely to develop. This procedure is known as a capsulectomy. 

For any patient interested in receiving breast implants in Manhattan, Dr. Preminger plans a consultation that includes a review of medical history, along with an explanation of the surgery and any risks involved with your proposed procedure. This consultation represents the optimum opportunity to address any questions and concerns you might have. As always, safety is the main concern of Dr. Preminger and her team with regard to any of the procedures that we perform.

We also follow these protocols regarding each patient interested in breast augmentation

  • Providing the patient with complete labeling information on all implant manufacturers that work with our office
  • Remaining watchful for any signs of BIA-ALCL, especially for patients dealing with late-onset seroma, a post-procedure complication following breast implant surgery that sees the breast swell at least a year after the implementation of the implants
  • In the unfortunate event that BIA-ALCL is detected, we collect any needed samples to be tested for pathology, we collaborate with your physician and oncologist to comprise the best treatment plan for you. Click here for more information on how we handle breast implant illness.

Breast Implant Removal in Manhattan

Thousands of women choose breast augmentation each year as a means to address concerns they have about their appearance. Breast augmentation also is one of the main specialties of Dr. B. Aviva Preminger. There is risk involved with any type of surgery, and while some of the numbers surrounding BIA-ALCL are concerning, you can be assured that Dr. Preminger and the staff of Preminger Plastic Surgery are doing everything in their power to provide you the highest level of care with the utmost safety. To learn more about our breast augmentation services, breast reduction, implant removal, or implant exchange, schedule a consultation with your board-certified plastic surgeon at Preminger Plastic Surgery today by calling (212) 706-1900.

Preminger Plastic Surgery is proud to serve our patients on the Upper East Side of Manhattan and anywhere in New York City, NY.

Sources

https://www.cbc.ca/news/health/breast-implants-rare-1.5422457

https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

https://journals.lww.com/plasreconsurg/Fulltext/2019/03001/Current_Risk_Estimate_of_Breast_Implant_Associated.7.aspx?WT.mc_id=HPxADx20100319xMP

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

https://www.thepsf.org/research/registries/profile