Back to All NewsJoint ASPS & ASAPS Advisory to Members on FDA's Update Regarding Breast Implant-Associated ALCL
Posted By American Med Spa Association, Wednesday, January 20, 2016
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The American Society of Plastic Surgeons (ASPS) and The American Society for Aesthetic Plastic Surgery
(ASAPS) would like to make their members aware of a recently issued FDA update regarding breast implants and anaplastic large cell lymphoma (ALCL), or breast implant-associated anaplastic large cell lymphoma, (BI-ALCL).
Overview:
In 2011, the FDA reported a detailed analysis of 34 cases. The recent FDA update summarizes the data reported to the MAUDE database, which as of September 10, 2015, now represents 258 medical device reports (MDR)s. Based upon this, the FDA estimates total number of US cases of breast implant associated ALCL to be between 100 and 250 cases. The FDA confirms women with breast implants do not need to change their routine medical care and follow up. The FDA specifically recommends reporting all confirmed cases of ALCL and breast implants to both the FDA and the PROFILE Registry.
For Members:
Where did this new information come from?
The new data appearing on the FDA website is a literature review of current BI-ALCL findings. You can find the relevant clinical information from Plastic and Reconstructive Surgery, the Journal of Clinical Oncology and JAMA.
Does ASPS or ASAPS believe there's a safety risk to women with implants?
No. BI-ALCL is an extremely rare and highly treatable type of lymphoma that can develop around breast implants. BI-ALCL is not a cancer of the breast tissue. Because BI-ALCL is so rare, there is limited data from clinical reports and more information is needed to fully understand the possible association between breast implants and ALCL.
What data is available?
According to the most recent data available, the risk of association between breast implants and ALCL is extremely low. A March 2015 study published in the journal Plastic and Reconstructive Surgery identified 173 individual patients presenting, via a world literature review, with ALCL since the issue was first reported in 1997.
Available data shows that most patients who do develop BI-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule.
If you have a patient diagnosed with ALCL, it is important to submit case information to the PROFILE Registry
The PROFILE Registry is for the purpose of centralizing and standardizing all reports of BI-ALCL to help determine if an association exists between ALCL and women with breast implants as well as for identifying potential risk factors and disease management practices. To begin submitting case information visit www.thepsf.org/PROFILE.
For Your Patients:
(ASAPS) would like to make their members aware of a recently issued FDA update regarding breast implants and anaplastic large cell lymphoma (ALCL), or breast implant-associated anaplastic large cell lymphoma, (BI-ALCL).
Overview:
In 2011, the FDA reported a detailed analysis of 34 cases. The recent FDA update summarizes the data reported to the MAUDE database, which as of September 10, 2015, now represents 258 medical device reports (MDR)s. Based upon this, the FDA estimates total number of US cases of breast implant associated ALCL to be between 100 and 250 cases. The FDA confirms women with breast implants do not need to change their routine medical care and follow up. The FDA specifically recommends reporting all confirmed cases of ALCL and breast implants to both the FDA and the PROFILE Registry.
For Members:
Where did this new information come from?
The new data appearing on the FDA website is a literature review of current BI-ALCL findings. You can find the relevant clinical information from Plastic and Reconstructive Surgery, the Journal of Clinical Oncology and JAMA.
Does ASPS or ASAPS believe there's a safety risk to women with implants?
No. BI-ALCL is an extremely rare and highly treatable type of lymphoma that can develop around breast implants. BI-ALCL is not a cancer of the breast tissue. Because BI-ALCL is so rare, there is limited data from clinical reports and more information is needed to fully understand the possible association between breast implants and ALCL.
What data is available?
According to the most recent data available, the risk of association between breast implants and ALCL is extremely low. A March 2015 study published in the journal Plastic and Reconstructive Surgery identified 173 individual patients presenting, via a world literature review, with ALCL since the issue was first reported in 1997.
Available data shows that most patients who do develop BI-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule.
If you have a patient diagnosed with ALCL, it is important to submit case information to the PROFILE Registry
The PROFILE Registry is for the purpose of centralizing and standardizing all reports of BI-ALCL to help determine if an association exists between ALCL and women with breast implants as well as for identifying potential risk factors and disease management practices. To begin submitting case information visit www.thepsf.org/PROFILE.
For Your Patients:
