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Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare but treatable lymphoma apparently associated with textured breast implants that occurs in the implant scar tissue capsule.
Symptoms include swelling and/or firmness of the breast, a lump in breast or armpit, pain, or a rash. It is highly treatable especially when diagnosed early after symptoms start. 93% of patients are disease free at 3 years following treatment (6).
There is no recommendation to prophylactically remove your textured implants if you have no signs or symptoms.
Even without symptoms, if you are concerned about your textured implants you should have a conversation with your Board Certified Plastic Surgeon who should be able to accurately explain your concerns and discuss your options including capsulectomy and removal or replacement with smooth implants if that’s where your discussion leads.
About BIA-ALCL
BIA- ALCL is not breast cancer. It is an uncommon but mostly treatable type of non-Hodgkin’s lymphoma that appears to develop exclusively in women with textured breast implants. It was first reported associated with breast implants in 1997. It occurs in the scar tissue capsule surrounding the implant. There has not been a case of BIA-ALCL in a patient with only smooth implants, however an association with smooth implants cannot yet be ruled out.
Symptoms
First symptoms are usually swelling of the breast over a period of days to weeks which can occur on average 8-9 years after implant placement with a range of 2-28 years. Swelling is due to a collection of fluid called a seroma, but not all fluid collections are positive for BIA-ALCL and the majority of seromas are benign, but should not be ignored. Other signs can be a lump in the breast or armpit, firmness, pain or a rash. It is usually completely treatable at early stages especially if patients see their doctor early at first symptoms.
If a seroma is suspected an ultrasound will be ordered and any fluid present will be removed and tested for BIA-ALCL. Mammograms are not useful in diagnosing BIA-ALCL.
Definitions
Capsule: All breast implants will cause your body to form a scar tissue capsule around the implant, this is a normal process.
Capsulectomy: the removal of the scar tissue capsule that forms around an implant as both the implant and capsule are removed.
En bloc capsulectomy: requires complete dissection and removal of all tissues surrounding the breast implant (capsule and rim of normal native breast tissue) and usually is reserved for cases of a known malignancy where the increased surgical risks are balanced against a potential cancer cure.
Treatment
Treatment of an ALCL positive diagnosis consists of an en bloc capsulectomy and textured implant removal. Treatment of textured implant concerns for ALCL usually consists of implant removal and full capsulectomy (these recommendations are still evolving as more data is obtained).
Capsulectomy or the less common en bloc capsulectomy is a very common procedures to all Board Certified Plastic Surgeons and is done frequently when other issues arise such as with implant leakage, capsular contracture, or other revision surgeries. It is not a specialized procedure or technique that only some plastic surgeons can perform — all plastic surgeons should be adept at this procedure. In advanced cases of a positive ALCL diagnosis chemotherapy and / or radiation have also been added, but in early stages the majority of patients require no additional treatment for their BIA-ALCL. It is not known however whether every patient will be cured.
Smooth implants can be placed at that time or the patient may choose not to have implants replaced and may be a candidate for a breast lift or fat grafting to help restore shape.
Causes
The cause of BIA-ALCL continues to be intensely studied. The best theory to date is that a combination of factors are required for its development:
- Textured implants
- Chronic bacterial inflammation/ biofilm
- Genetic predisposition
- Time
There is no blood test to screen for BIA-ALCL and no test to determine if one textured implant patient is at any more risk of developing this than any other patient.
Expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams, as the most important issue for women with breast implants is to continue to screen for breast cancer.
Recommendations
Neither the FDA nor any plastic surgery society or worldwide regulators currently recommends asymptomatic women should preventatively remove their textured breast implants to prevent BIA-ALCL. However, I have consulted and operated on asymptomatic women who were concerned enough to have their textured implants removed or changed to smooth. There are always risks associated with any surgery and these need to be discussed if you are thinking of prophylactically removing or replacing implants, as the risks associated with surgery may be higher than the risk of developing BIA-ALCL.
Personally and professionally, I feel that if this is something you are anxious about and think about BIA-ALCL daily, then it is reasonable to address this with a revision surgery and exchange to a smooth implant and capsulectomy which will be further discussed at your consult.
What Is the Risk of Developing BIA-ALCL?
As of August 2020, the FDA update reported there have been 733 (and currently maybe as many as 800) cases globally and 36 deaths (13 in the U.S) since it was first reported 20 years ago.
Worldwide it is estimated that approximately 35 million women have textured breast implants (1). Approximately 300,000-400,000 (possibly higher) smooth and textured implants are placed each year in the U.S. (1)
The FDA reports that the current lifetime risk of developing BIA-ALCL is 1:3,817 to 1:30,000 of women with textured implants. The risk assessments are changing on an ongoing basis and can vary based on geography, possible ethnic variations, and the type of implant which makes a global lifetime risk assessment difficult.
The incidence is related to the type of texturing. It appears the more aggressive the texturing the higher the risk.
Allergan has complied with a voluntary removal of their Biocell textured implant from the market as of July 2019 because it had the most aggressive texturing and the majority of cases. Mentor and Sientra (both of which have had BIA-ALCL cases) were not asked to remove their textured implants and still market their textured and shaped breast implants.
The risk with the Allergan Biocell implant is approximately 1:3,200 cases (0.03%). The risk with the Mentor Siltex textured implant is approximately 1:60,000-80,000 (0.0016%-0.0012%). The risk with the Sientra implant is approximately 1:160,000 – 200,000 cases (0.0006%-0.0005%).
As mentioned above, there is no recommendation from the FDA or any plastic surgery society for women (even with the Allergan Biocell textured implant) to have their implants prophylactically removed if they are not experiencing any symptoms.
None of my cosmetic patients received the Allergan Biocell implant.
Risk Comparisons
It is estimated that 5-10 million U.S. women have breast implants. Approximately 300,000-400,000 women each year in the U.S. receive breast implants (cosmetic or reconstruction) (historically approximately 13% of these were with textured implants). There have been only 385 BIA-ALCL cases reported in the U.S. (5), with no reports of cases associated with tissue expanders.A woman’s risk of the following is higher than developing BIA-ALCL(2)
- Death in a car accident in a lifetime is 0.15% (1:165)
- Breast cancer in women’s lifetime, 12.5% (1:8)
- Re operation through 10 years, 31.6%
- Capsular contracture through 10 years, 13.5%
- Breast implant rupture through 10 years, 8.7%
Does Saline or Silicone Make a Difference?
BIA-ALCL has been associated with silicone and saline textured implants. It is the implant surface type that is associated with BIA-ALCL, not what’s inside.
It is important to remember that texturing is associated with BIA-ALCL, but has not yet scientifically been established as the CAUSE of BIA-ALCL.
Many plastic surgeons continue to use textured implants in certain situations based on individual patient needs and the unique properties of textured implants. Although textured implants were only a small percentage of my practice, I have chosen (several years ago) to stop using them because of the strong association with BIA-ALCL (even though the risk is small), and the ability it seems to prevent this by not using textured implants.
Having a smooth implant in place also simplifies the work up or diagnosis for any breast concerns in the future.
Resources for additional and ongoing information can be found at www.plasticsurgery.org, surgery.org, and https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants.
References
- Collett DJ,Rakhorst H, Lennox P, Magnusson am,Cooter R, Deva A: Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants.Plastic and Reconstructive Surgery Supplement Mar 2019; 143(3S):30S-40S
- Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG: Long Term Safety of Textured and Smooth Breast Implants. Aesth Surg Journal Jan 2018; 38(1):38-48.
- The Aesthetic Society ( ASAPS) Advisory Update: August 2020 FAQ BIA-ALCL
- American Society of Plastic Surgeons (ASPS) BIA-ALCL Advisory Update: August 2020.
- FDA website
- Clemens,M. BIA-ALCL Resources. American Society of Plastic Surgeons. August 2019. www.plasticsurgery.org/for-medical-professionals/health-policy/bia-ALCL-physician-resources/by-the-numbers
- Rohrich RJ,Kaplan J, Dayan E: Silicone Implant Illness: Science versus Myth? PRS 144(1):98-109, July 2019.
