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Keyword: implants, In portal: Breast Cancer
Update : FDA reports on new cancers linked to breast implants
Most relevant for: People with breast implants
New cancers have been found in women with both textured and smooth implants that are filled with either saline or silicone. These cancers are extremely rare. The FDA has reported cases of a type of skin cancer and blood cancers in the scar tissue that forms around breast implants. The newly reported lymphomas are different from the previously reported breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). (Posted 9/27/22). Este artículo está disponible en español.
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Update : Stronger guidance about breast implant safety
Most relevant for: People with or considering breast implants
The FDA issued new guidance for breast implants so that all people with breast implants have the appropriate information to understand and make decisions about their healthcare. Required features include box warning, patient decision checklist, guidelines for screening for implant ruptures and patient device cards. (posted 12/14/21)
Este artículo está disponible en español.
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Update : FDA updates reported harmful events linked to breast implants
Most relevant for: People who have or are considering breast implants.
The FDA has updated reported cases of breast implant-associated cancer and breast implant illness. Included in this update is approval of a questionnaire that asks about quality of life and satisfaction with breast implants. (10/20/20). Note: On October 27, 2021 the FDA announced stronger guidance on breast implant safety.
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Guideline : FDA asks Allergan to recall certain textured breast implants
Most relevant for: Women with, or considering breast reconstruction with implants
On July 25, 2019, the Food and Drug Administration requested that breast implant manufacturer Allergan recall its BIOCELL textured implants and expanders due to an association with a rare type of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. The FDA does not recommend removing implants for people who do not have disease symptoms. This XRAYS review updates information about this FDA recall. (7/29/19)
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Relevance: Medium-Low
Strength of Science: Low
Research Timeline: Post Approval
Study : Breast cancer implant study suggests links with illness but has serious flaws
Relevance: Medium-Low
Strength of Science: Low
Research Timeline: Post Approval
Most relevant for: Women with or considering breast implant reconstruction
THIS INFORMATION HAS BEEN UPDATED: In October 2021, the FDA issued guidance for people with breast implants Read our latest review on this topic.
An article in the Annals of Surgery, researchers conclude that their work supports an association between silicone breast implants and a range of conditions. This journal article was accompanied by two editorials in which experts voiced their disagreement with the way the analysis was performed and the conclusions of the authors. (2/21/19)
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Study : FDA updates report on risk of lymphoma from breast implants
Most relevant for: Women who currently have textured implants or expanders or who have had them in the past
Note: On 07/25/19, the FDA announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL. On October 27, 2021 the FDA announced stronger guidance on breast implant safety.
In March 2017, the Food and Drug Administration reported that patients with breast implants may be at increased risk for a rare type of lymphoma. This was covered in a previous XRAYS review. The FDA has continued to collect data since the first reported association in 2011. Recently, the agency released an update on the number of reported cases of breast implant-associated lymphoma and lifetime risk estimates for women with textured breast implants. (04/02/18)
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Study : FDA report claims women with breast implants may be at risk for rare cancer
Most relevant for: Women who had or are consideration breast reconstruction with implants
THIS INFORMATION HAS BEEN UPDATED. The FDA issued an update in March, 2018 about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This was covered in a more recent XRAY review. On 07/25/19, the FDA announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL. This was also covered in a more recent XRAY review.
Recent headlines highlighted an FDA report stating that patients with breast implants may be at increased risk for a rare type of non-Hodgkin lymphoma. What is the scientific evidence behind this claim? (4/21/17)
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