Recent media reports covering an FDA safety update, as well as the recent FDA panel hearings and the recent recall of Allergan textured implants and tissue expanders, have raised patient concerns regarding a very rare and treatable type of lymphoma that can develop around breast implants. My top concern is the safety and well-being of my patients. In order to alleviate concerns and educate our patients on the actual known risks of developing BIA-ALCL, I have put together the following summary and frequently asked questions. You can also give our Washington, D.C., office a call today at (202) 810-7700 today to schedule your Breast Implant-Associated ALCL consultation.
About the recent FDA Safety Update – August 20, 2020
The information provided in the recent FDA update is not based on a study, but rather from the BIA-ALCL Medical Device Reports (MDRs) submitted to FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA reports 733 unique cases globally and 36 patient deaths.1 The FDA does report that the actual incidence or prevalence of BIA-ALCL cannot be determined solely on the MAUDE database. MDRs that they have received “may contain incomplete, duplicate, inaccurate, untimely, unverified” data and therefore, should not be interpreted as a definitive number of cases. There are an estimated 5 million US women with implants. The FDA’s update was not released with the intent to make women panic, but rather to increase patient and surgeon awareness of potential symptoms of a very rare condition as well as to inform that BIA- ALCL is easily diagnosable and treatable in the vast majority of cases.
BIA-ALCL: What we know
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a very rare and treatable type of lymphoma that was initially reported in 1997. Since then a number of publications arising from current confirmed cases and textured implant sales data estimate the current lifetime risk to be between 1:2,207 – 1:86,029. It is important to note that there are variable risks reported in different geographic locations around the world, the highest being Australia and New Zealand. It is also important to note that most of the cases of BIA-ALCL are linked to one manufacturers specific type of texturing. The American Society of Plastic Surgeons has been keeping their own database of confirmed cases and 307 unique US cases have been reported to that registry.
BIA-ALCL is NOT breast cancer. To date, all confirmed cases of BIA-ALCL have been in women with textured implants, however the association with smooth implants cannot be excluded. BIA-ALCL has been diagnosed in women with silicone and saline implants. All women with breast implants should do routine monthly self-breast exams and follow up routinely with a board-certified plastic surgeon.
BIA-ALCL: Symptoms and Treatment
BIA-ALCL presents as sudden swelling of the breast (this is called a late seroma) or as a mass adjacent to the implant. The majority of cases presented, on average, 8 years following implantation, with a range of 2 to 28 years.
The majority of patients who are diagnosed with BIA-ALCL can be cured of their disease by removal of the implant and removal of the capsule surrounding the implant. Infrequently, patients will need to undergo chemotherapy or radiation therapy. It’s important to note that 93% of patients are disease free at 3 years follow-up, which is an excellent prognosis when treated appropriately.
Not All Implant Texturing is the Same
When assessing the risk of textured implants and BIA-ALCL, it’s important to note that the individual implant manufacturers have their own means of creating the texture on the implant, and the risk is not the same for ALL women with textured implants. According to FDA data, when manufacturer is know for women with textured implants who have developed BIA-ALCL, 90.5% involved an Allergan implant, 7.1% Mentor, and 1% Sientra.
In my practice I have always used Sientra or Mentor textured implants. Two recent publications quote the incidence of BIA-ALCL with a Sientra textured implant to be 1:300,000 and a Mentor textured implant to be 1:60,631.2,3 Given these numbers, I continue to recommend and use Sientra textured implants when indicated.
Assessing Risk and Understanding the Numbers
It is important to understand how rare this disease is and put the numbers in perspective. Worldwide, there have been 656 cases of BIA-ALCL reported. Current conservative estimates suggest that 35 million women worldwide have textured implants. In 2018, around 313,000 women underwent breast augmentation and 83,000 women underwent breast reconstruction with implants. It’s important to keep in mind:
- The average Woman’s Risk of Developing Breast Cancer in her lifetime is 12.5%.
- The risk of developing recurrent breast cancer after mastectomy is 5-8%.
- The risk of breast implant rupture at 10-years is about 8%.
- Lifetime risk of death in a car accident is 0.15%
- The risk of developing ALCL from a Sientra textured breast implant is 1 in 300,000 or .0003%.
- The risk of developing ALCL from a Mentor textured breast implant is 1 in 60,631 or .0016%
Why use textured breast implants?
In my opinion, it’s important to be able to offer a highly individualized surgical plan to each of my patients. This includes being able to offer a wide variety of implants of differing shape, size and surface. Textured implants are often used when there is concern about the implant moving in its pocket, particularly with women who have severe chest wall or breast deformities, or in cases where there is an increased risk of capsular contracture. Shaped implants are used to create a more natural upper breast pole in patients undergoing reconstruction in front of the muscle (pre-pectoral) or in patients that may have wider breasts and shorter torsos (the shape gives the breast a more natural oval appearance rather than a round appearance). The textured implant surface also helps prevent the shaped implant from rotating which would give the breast a distorted appearance.
There is not one implant that is right for every patient. I discuss with each patient the choices of implants and explain why I would suggest using one implant over the other. After a discussion of the risks and benefits of each type of implant, the final decision is the patients.
Once again, it’s important to note that there may be an association between textured implants and BIA-ALCL given the greater surface area of a textured implant but there is still no evidence that implant texturing CAUSES BIA-ALCL.
All breast implants have established long-term safety data available and the incidence of BIA-ALCL is low.
Dr. Pittman testifies at the most recent FDA panel on the safety of Breast Implants.
Frequently Asked Questions
Should patients have their implants removed?
Neither the FDA nor any of the leading Plastic Surgery societies suggest additional screening or removal of implants for asymptomatic women. This also applies to women who have Allergan BIOCELL textured implants.
Should women with breast implants be screened for BIA-ALCL?
All women with breast implants should follow their normal medical care and follow-up with a Board-Certified Plastic Surgeon. This includes normal breast self-exam and mammogram when appropriate. Expert opinion is that asymptomatic women without breast changes do not require more than routine follow-up. If a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo examination and appropriate imaging, including ultrasound and fine needle aspiration of any peri-implant fluid.
How is BIA-ALCL Diagnosed?
If a woman develops swelling in her breast or feels an abnormal mass, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested with CD30 immunohistochemistry to diagnose BIA-ALCL. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases MRI and PET/CT scans may be performed to help stage the disease.
BIA-ALCL is a condition that I take very seriously and have spent a tremendous amount of time investigating. Currently, I see no reason to limit the choices that I offer my patients. I believe in educating my patients about their options, which includes the risks and benefits of each procedure, as well as each device. It is also important that if you have implants, you discuss any abnormal changes in your breast with your plastic surgeon immediately.
Call Somenek + Pittman, MD To Learn About Breast Implant-Associated ALCL!
Be sure to give us a call at (202) 810-7700 today if you wish to learn more about Breast Implant-Associated ALCL. You can also schedule a consultation to speak with our team about your potential treatment options. Our practice looks forward to serving you!
- FDA Website, accessed 7/24/19: https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
- Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG: Long-term Safety of Textured and Smooth Breast Implants. Aesthet Surg Journal Jan 2018; 38(1):38-48 (ASJ BEST JOURNAL ARTICLE PAPER 2018)
- Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK: Current Risk Estimate of Breast-Implant Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants Mar 2019; 143(3S): 30S-40S