Posts tagged with "Breast cancer"

FDA proposes that manufacturers and doctors warn women about risks of breast implants

October 24, 2019

Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration (FDA) said on October 23, according to a report by The New York Times.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, the Times said, and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery.

The measures are not mandated by the agency; they are proposals now open to public comment and industry input.

Millions of women have implants—silicone sacks filled with either saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomies for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure, the news outlet notes: Some 313,000 augmentations were performed in 2018, a 4% increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

In turn, thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue, a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases. Implants have also been linked to a rare cancer of the immune system called anaplastic large cell lymphoma, which can be fatal. Most of the cancer cases developed in women with textured implants.

The agency warned two implant manufacturers earlier this year that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

At an advisory panel meeting in March, women with breast implants testified about their illnesses and implored the agency to take action. More than 70,000 women signed a petition demanding the F.D.A. to require the checklist.

Advocates urged agency officials to require the long-term safety studies that were promised and to start patient registries to track outcomes. Some women asked the F.D.A. to ban breast implants altogether.

According to the Times report, agency officials said they had “heard loud and clear” that there was “a distinct opportunity to do more to protect women who are considering implants.”

The F.D.A. also wants implant manufacturers to list the ingredients in implants, in an easy-to-understand format for patients, so that women know about chemicals and heavy metals in the products.

The agency also is proposing new screening recommendations for women who already have silicone gel implants, saying they should undergo imaging scans to look for ruptures beginning five to six years after the surgery and every two years after that, the Times reported.

At the request of the F.D.A., Allergan in July recalled textured breast implants linked to the unusual cancer.

 Research contact: @nytimes

Skin deep: Chemicals in cosmetics alter women’s hormone levels

September 17, 2018

It’s time to face up to the facts: The cosmetics and creams women use every day may cover their flaws and accentuate their best features, but they also can pose a critical risk. New research has established that chemicals found in many beauty products are linked to changes in hormones.

Indeed, the new research results—published in Environment International by Assistant Professor of Global and Community Health Anna Pollack, Ph.D., and colleagues at Fairfax, Virginia-based George Mason University—discovered links between chemicals that are widely used in cosmetic and personal care products and changes in reproductive hormones that can lead to serious conditions, including breast cancer and cardiovascular disease. .

For their study, the authors collected 509 urine samples from 143 healthy women between ages of 18 and 44. Participants did use birth control and had no prior history of any chronic ailments. Urine was analyzed for environmental chemicals commonly found in cosmetic and personal care products.

The authors found numerous adverse effects on reproductive hormones when these chemicals were present—especially parabens (antimicrobial preservatives) and benzophenones (ultraviolet filters). They say that even low levels of exposure to mixtures of chemicals can alter levels of hormones.

“We have early indicators that chemicals such as parabens may increase estrogen levels,” says Pollack, in a university press release. “If this finding is confirmed by additional research, it could have implications for estrogen dependent diseases such as breast cancer.”

This study is the first to examine mixtures of chemicals that are widely used in personal care products in relation to hormones in healthy, reproductive-age women, using multiple measures of exposure across the menstrual cycle, which improved upon research that relied on one or two measures of chemicals,” Pollack noted.

This multi-chemical approach more closely reflects real-world environmental exposures and shows that even low-level exposure to mixtures of chemicals may affect reproductive hormone levels. Another noteworthy finding of the study is that certain chemical and UV filters were associated with decreased reproductive hormones in multi-chemical exposures while others were associated with increases in other reproductive hormones, underscoring the complexities of these chemicals.

“What we should take away from this study is that we may need to be careful about the chemicals in the beauty and personal care products we use,” explains Pollack. “We have early indicators that chemicals such as parabens may increase estrogen levels. If this finding is confirmed by additional research, it could have implications for estrogen dependent diseases such as breast cancer.”

Research contact: apollac2@gmu.edu