RISKS OF
BIA-ALCL

Comparing Different Implant Brands

Mentor
TEXTURE
Smooth
Textured: Microtextured
SILICONE CONSISTENCY

Cohesive I - The standard cohesive level gel used in Mentor’s implants.

This is Mentor’s softest gel - round, will hold its shape.

Cohesive I, OR

Cohesive II - A slightly firmer gel, for a firmer feeling implant - round, will hold its shape.

MemoryGel Xtra - Mentor’s firmest implant, with increased projection and fullness.

BIA-ALCL RISK

None: According to Mentor

10 years of published data

1 in 86,029: according to Mentor

10 years of published data

Motiva
TEXTURE
Smooth
Textured: Microtextured
SILICONE CONSISTENCY

“ProgressiveGel PLUS: A balanced gel elasticity and firmness” - round, will hold its shape

“ProgressiveGel PLUS, OR

“ProgressiveGel Ultima: An elastic and softer gel” - will act more like a teardrop implant as the gel is softer

BIA-ALCL RISK

None: according to Motiva

3 years of published data

None: according to Motiva

3 years of published data

Polytech
TEXTURE
Textured: Microtextured OR Macrotextured OR Nanotextured
SILICONE CONSISTENCY

Firm cohesive silicone gel - round, will hold its shape

BIA-ALCL RISK

None: according to Polytech. Polytech estimate that the risk is 3 in 1,100,000

10 years of published data

Nanotextured only has approved <3 years of published data

Further Reading

Notes from Journal Articles

According to FDA: there are approximately 660 recorded cases of BIA-ALCL. There is a seemingly higher occurrence in textured implants.

• Normal breast cancer (with or without implants) occurs in 1 in 8 women.

• From a strictly scientific view there is no link between surface texture and BIA-ALCL as there is no clear clinical evidence.

• For approximately 30% of the recorded cases there is no information on the type of implant used.

• FDA have reported 30 cases of BIA-ALCL in SMOOTH implants (however the FDA state there is no adequate history).

• Since the early 1990s until today, the ratio of textured vs smooth implants used is:
Textured 85% – 90%
Smooth: 10% – 15%

• Therefore, the fact that there are more BIA-ALCL cases with textured than with smooth implants is normal, because approximately 85% more textured implants are sold worldwide than smooth implants.

• The overall data on BIA-ALCL to date, is based on the reported cases and not on prospective, controlled trials, as required by evidence-based medicine.

BIA-ALCL Put Into Statistics

The highest priority in breast surgery is always the safety and well-being of patients. With recent concerns about BIA-ALCL, it is important to recognize how rare it is. Through 2015, there were 173 confirmed cases of BIA-ALCL.56 That same year, 364,000 women underwent breast augmentation and reconstruction with implants. For comparison, here are other
incidence rates:

• Risk of breast implant rupture through 10-years is 8.7% (1 in 11.5).25

• Risk of capsular contracture through 10-years is 13.5% (1 in 7.4).25

• Risk of reoperation through 10-years is 31.6% (1 in 3).25

• Average woman’s risk of developing breast cancer in her lifetime is 12.5% (1 in 8).57

• Risk of developing recurrent breast cancer after mastectomy is 5% to 8% (1 in 12.5-20).58

• Risk of death in a car accident in a lifetime is 0.15% (1 in 645).59

• Risk of death from complications from a cosmetic procedure is 0.002% (1 in 50,000).60

• Risk of developing BIA-ALCL associated with a breast implant is 0.003% (~1 in 30,000).54

• Risk of developing advanced BIA-ALCL with lymph node metastasis is approximately 0.0004% (~1 in 250,000).54

• Risk of developing BIA-ALCL and not resolved within 3 years is approximately 0.0002% (~1 in 500,000).54

References

Long-Term Safety of Textured and Smooth Breast Implants
https://academic.oup.com/asj/article/38/1/38/4259312

Association Between Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk and Polyurethane Breast Implants: Clinical Evidence and European Perspective
https://academic.oup.com/asj/article/39/Supplement_1/S49/5304917

Breast Aesthetics Company POLYTECH Releases Official Statement Following the French Health Authority Decision
https://www.prnewswire.com/il/news-releases/breast-aesthetics-company-polytech-releases-official-statement-following-the-french-health-authority-decision-300824975.html

Association Between Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk and Polyurethane Breast Implants: Clinical Evidence and European Perspective
https://academic.oup.com/asj/article/39/Supplement_1/S49/5304917