US FDA: rules on breast implants, fillers and medication

Image copyright Getty Images Image caption The FDA set out new recommendations for both breast implants and fillers The US Food and Drug Administration has issued new restrictions on the sale of breast implants…

US FDA: rules on breast implants, fillers and medication

Image copyright Getty Images Image caption The FDA set out new recommendations for both breast implants and fillers

The US Food and Drug Administration has issued new restrictions on the sale of breast implants and suggested stronger warnings about their risks.

Breast implants, which can cause complications and cancer, were banned nationwide for all but breast cancer-free women in 1990.

But the FDA is recommending other countries ban the implants.

The new recommendations are due to take effect on 13 March.

The new measures include:

Creating a mandatory registry of women who have breast implants, to determine if there are early warning signs of cancer.

Guaranteeing full reimbursement to those who have had implants removed, if they continue to have problems, so they do not have to spend money on unnecessary operations.

Requiring new patients to receive official labels describing the risks and potential complications of the procedures.

Developing a programme in the US to test the safety of breast implants using experimental drugs that still carry an unproven risk.

The agency’s latest advice to consumers came in November but was suppressed from the public, The New York Times reports.

In 2000, the FDA warned doctors about the risk of a type of tumour known as non-papillary primary breast cancer, a type which can develop up to five years after a breast implant.

Breast cancer deaths in the US are currently at 41.7 per 100,000 women. The FDA said 19 per cent of patients in the registry were reported to have developed breast cancer in the 10 years after getting a breast implant.

The FDA said 1.5-2% of patients who receive a breast implant are at risk of breast cancer in the 10 years after.

The costs and complications for women who have implants

In addition to the cancer risk, the FDA says that leaking silicone gel breast implants can cause infections, fluid and water retention, numbness and pain.

Some women have gotten silicone implants in the UK, though there are no official statistics as to how common the procedure is.

In some cases, the risk of infection, skin problems and other complications can be higher than the life-expectancy of women having implants.

According to the American Society of Plastic Surgeons, the volume of breast implants performed in the US fell from over 600,000 in 2001 to under 300,000 in 2012.

While there are concerns about women’s health after having implants, there has been little evidence of a rise in breast cancer or other complications.

This lack of evidence has led to disputes about whether the silicone gel products are still safe after a user’s years of use.

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But the FDA has acknowledged its own concerns, warning in November that earlier guidelines had been “under-enforced”.

Some countries have already banned the implants outright.

Theresa Woolf, a professor of surgery at Imperial College London, says the FDA recommendations will introduce more financial security for women who are having implants taken out.

“I do see the fear of increased costs [as a factor in banning silicone gel implants], but implants are a more expensive procedure than a lot of other procedures, but the costs seem to be rising,” she says.

Professor Woolf says that one woman who had a hysterectomy due to cancer was quoted £20,000 to have silicone gel implants replaced with silicon implants.

“I don’t think that many women will go back to having it,” she says.

However, Professor Woolf adds that some women have improved survival rates with the implants replaced, while some women with the implants have been left with pain and the abnormal growth of tissue and breast tissue.

Woman’s BBC Radio 5 live breast implant implant

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