Canadian breast implant cohort: Extended follow-up of cancer incidence - Pan - 2012 - International Journal of Cancer - Wiley Online Library

Canadian breast implant cohort: Extended follow-up of cancer incidence -  International Journal of Cancer

Abstract

Cosmetic breast implants are not associated with increased breast cancer incidence, but variations of risk according to implant characteristics are still poorly understood. As well, the assessment of cancer risk for sites other than breast needs to be clarified. The purpose of this study was to fill these research gaps. This study presents an extended analysis of 10 more years of follow-up of a large Canadian cohort of women who received either cosmetic breast implants (n = 24,558) or other cosmetic surgery (15,893). Over 70% of the implant cohort was followed for over 20 years. Cancer incidence among implant women was compared to those of controls using multivariate Poisson models and the general female population using the standardized incidence ratios (SIRs). Women with breast implants had reduced rates of breast and endometrial cancers compared to other surgery women. Subglandular implants were associated to a reduced rate of breast cancer compared to submuscular implants [incidence rate ratio (IRR) = 0.78, 95% confidence interval (CI) = 0.63–0.96] and this reduction persisted over time. We observed a sevenfold increased rate (IRR = 7.36, 95% CI = 1.86–29.12) of breast cancer in the first 5 years after the date of surgery for polyurethane-coated subglandular implant women but this IRR decreased progressively over time (p value for trend = 0.02). We also observed no increased risk of rarer forms of cancer among augmented women. A reduction in breast cancer incidence was observed for women with subglandular implants relative to women with submuscular implants. Possible increase of breast cancer incidence shortly after breast augmentation with polyurethane implants needs to be verified.

FDA Approves New Silicone Gel-Filled Breast Implant

FDA Approves New Silicone Gel-Filled Breast Implant:

The U.S. Food and Drug Administration (FDA) has approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age.

As a condition of approval, the company is required to conduct post-approval studies to assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
Silicone gel-filled breast implants are implanted under breast tissue or chest muscle for breast augmentation or reconstruction. They have a silicone outer shell that is filled with silicone gel and come in different sizes.

Breast reconstruction may refer to a primary reconstruction to replace breast tissue that has been removed or revision surgery to correct the result of a primary reconstruction surgery.

The FDA based its approval of Sientra’s implant on 3 years of clinical data from 1,788 participants. Complications and outcomes reflected those found in previous studies of other breast implants and included tightening of the area around the implant (capsular contracture), reoperation, implant removal, an uneven appearance (asymmetry), and infection.
Sientra’s post-approval studies will include:

• An additional 7 years of follow-up of the 1,788 clinical trial participants in their pre-market study
• A 10-year study of 4,782 women receiving Sientra silicone gel-filled breast implants to collect information on long-term local complications such as capsular contracture, as well as less common disease outcomes, such as rheumatoid arthritis and breast and lung cancer
• Five case-control studies that will evaluate the association between Sientra’s silicone gel-filled breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, and lymphoma.

With the addition of Sientra’s approval, there are now three FDA-approved silicone gel-filled breast implants on the market in the U.S.
Silicone gel implants have generated a fair amount of controversy regarding their safety because of the question as to whether they can trigger certain connective tissue and autoimmune diseases. In 1992, the FDA restricted the use of silicone implants in order to evaluate whether they were indeed associated with autoimmune conditions. Clinical trials have continued and the data continues to indicate that the implants are safe.
It’s important to remember that breast implants are not lifetime devices and long-term monitoring is imperative.
Reference:
FDA approves new silicone gel-filled breast implant [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm”>http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437.htm

Canadian breast implant cohort: Extended follow-up of cancer incidence

Blogger's Note: prior Canadian patient-led lawsuits failed
                                 ~~~~~~~~~~~~~~~~~

Canadian breast implant cohort: Extended follow-up of cancer incidence:

Abstract

Cosmetic breast implants are not associated with increased breast cancer incidence, but variations of risk according to implant characteristics are still poorly understood. As well, the assessment of cancer risk for sites other than breast needs to be clarified. The purpose of this study was to fill these research gaps. This study presents an extended analysis of 10 more years of follow-up of a large Canadian cohort of women who received either cosmetic breast implants (n=24,558) or other cosmetic surgery (15,893). Over 70% of the implant cohort was followed for over 20 years. Cancer incidence among implant women was compared to those of controls using multivariate Poisson models and the general female population using the Standardized Incidence Ratios (SIRs). Women with breast implants had reduced rates of breast and endometrial cancers compared with other surgery women. Subglandular implants were associated to a reduced rate of breast cancer compared to submuscular implants (Incidence Rate Ratio (IRR) = 0.78, 95% CI= 0.63-0.96) and this reduction persisted over time. We observed a 7-fold increased rate (IRR = 7.36, 95% CI= 1.86-29.12) of breast cancer in the first five years after the date of surgery for polyurethane-coated subglandular implant women but this IRR decreased progressively over time (p value for trend = 0.02). We also observed no increased risk of rarer forms of cancer among augmented women. A reduction in breast cancer incidence was observed for women with subglandular implants relative to women with submuscular implants. Possible increase of breast cancer incidence shortly after breast augmentation with polyurethane implants needs to be verified.

FDA review indicates possible association between breast implants and a rare cancer anaplastic large cell lymphoma (ALCL) - lymphoma

Medical News: Implant Focus Shifts to Rarity of Implant-Related Cancer - in Product Alert, Devices and Vaccines from MedPage Today

FDA review indicates possible association between breast implants and a rare cancer (see Blogger's Notes on this issue)

Blogger's Notes: for background information regarding the long standing health issues concerning breast implants do a 'litigation' search. Past research on
the issue of risk/breast implants (noncancer/cancer issues) includes many
lawsuits, the latter of which were settled by some of the manufacturers without admission of fault (guilt). The past lawsuits (class action suits) were based on the older forms of implants.