Issue of BIA-ALCL and Textured Implants
Several of our previous articles have discussed the connection between textured breast implants and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). France, Canada, Australia, and other countries have taken steps to ban or have already banned certain textured implants. You can refer to our most recent article on the topic, “Textured Breast Implants Ban: Onto Australia”, for more information as to why health officials there decided to make this decision.
In January 2018 our article, “New Data Released on Risk of Lymphoma Due to Breast Implants“, provided statistics of the risk of BIA-ALCL with certain types of implants. “82% of the women in the study with BIA-ALCL had ‘macrotextured’ implants, while the remaining 18% had ‘microtextured’ implants.” In addition, it provided statistics of the age associated with the risk of BIA-ALCL:
- At age 50: 1 in 35,000
- At age 70: 1 in 12,000
- At age 75: 1 in 7,000
Statement from the FDA in May
Once word got out about the potential risk of BIA-ALCL in relation to textured implants, the FDA held meetings and made public statements. Read our previous article from April, “March 2019 FDA Meeting on Breast Implants: A Summary of What You Need To Know“, to learn about what took place when the FDA addressed this issue.
On May 2, 2019 the FDA released a statement pertaining to the issue where they said:
The agency has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions.
Though textured breast implants have yet to be banned in the United States, more recently there have been additional studies on the risk of BIA-ALCL.
Studies on the Risk of BIA-ALCL
The Cancer Therapy Advisor article, “Prospective Evidence Links Textured Breast Implants to Rare Lymphoma“, provides insight from a recent 2019 American Society of Clinical Oncology meeting, where the results of a study on complications women experience after breast implant surgery were discussed. They concluded that the risk is higher than it has been previously.
This study was reportedly comprised of 3,456 women who had textured breast implants put in by the same surgeon from 1993 to 2017, 96.7% of which were Allergan Biocell:
Biocell is a textured breast implant marketed by Allergan, and the product has been recalled by dozens of countries, but is still being sold in the United States.
The patients, whose age averaged at 48 years old, were followed for an average of 7 years. 8 of the 3,456 women eventually got diagnosed with ALCL after an average of 11.2 years, also meaning 1 out of every 433 women.
It is apparent that the numbers of reports and diagnoses are growing, suggesting that the risk is real and all medical professionals and patients need to be fully aware. As always, we will continue to monitor the situation of breast implants and BIA-ALCL and deliver any new or relevant information that we find.
Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Previous articles on this topic:
- Textured Breast Implants Ban: Onto Australia
- When Might The FDA Ban Textured Implants In The US?
- FDA Fails When It Comes to Banning Textured Breast Implants
- Textured Breast Implants Bans on the Rise
- March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know
- Breast Implants FDA March 2019 Meeting: Lymphoma Cancer Was A Main Topic