This letter is in response to your two Citizen Petitions dated November 17, 1994 and May 13, 2008, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products. Your 1994 Petition requests that all cosmetic talc bear labels with a warning such as \"Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area increases the risk of ovarian cancer.\" Additionally, your 2008 Petition requests that cosmetic talcum powder products bear labels with a prominent warning such as: \"Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.\" Further, both of your Petitions specifically request, pursuant to 21 CFR 1 0.30(h)(2), a hearing for you to present scientific evidence in support of this petition.

The Department of Health and Human Services.

Purpose Breast implant‐associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown.

/pdf/breast-implant-associated-anaplastic-large-cell-lymphoma-4svf37e2hz.pdf

Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients

Background:Capsular contracture remains the most common complication following augmentation mammaplasty. The infective hypothesis implicates subclinical infection with biofilm in its pathogenesis. The authors developed an in vivo model of subclinical infection and biofilm formation to further invest

Subclinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammaplasty.

BACKGROUND: A study was performed to investigate histological changes in capsules formed around silicone breast implants and their correlation with the clinical classification of capsular contracture defined by the Baker score. For histological classification, the authors used the classification introduced by Wilflingseder, which identifies four grades of contracture. METHODS: The study included 24 female patients (average age, 40 +/- 12 years) with capsular contracture after bilateral cosmetic breast augmentation with smooth silicone gel implants (Mentor, Santa Barbara, Calif.). The Baker score was determined preoperatively for each patient. Samples of capsular tissue were obtained from all patients for histologic and immunohistochemical analyses. Capsular thickness, age of the collagen fibers, presence of synovia-like metaplasia on the inner surface of the capsule, number of histiocytes, giant cells, and other inflammatory cells, amount of silicone, foreign body granulomas, and capsule calcification were evaluated. RESULTS: There was a positive correlation between capsular thickness (p < 0.05) and Baker score. Silicone-containing deposits were found in all four histological capsule types. A trend toward greater capsular thickness was documented in patients with severe inflammatory reaction. These patients also had more clinical symptoms. Greater capsular thickness was associated with a higher number of silicone particles and silicone-loaded macrophages in the peri-implant capsule. CONCLUSIONS: The authors demonstrated a positive correlation (p < 0.05) between the clinical classification (Baker score I to IV) and the histological classification introduced by Wilflingseder (Wilflingseder score I to IV). An exact histological classification is needed to describe precisely the morphological changes in capsular contracture.

Clinical and morphological conditions in capsular contracture formed around silicone breast implants

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140673697031644.pdf

Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis

Purpose: To review the range of local and systemic complications attributed to silicone breast implants and to evaluate the epidemiologic literature on these complications. Data Sources: Epidemiolo...

S. L. Brown

Papers

Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review