FDA recommends tighter regulations on breast implants made by Four companies

The U.S. Food and Drug Administration released a set of recommendations on Friday for tighter regulation of breast implants made by Allergan, Siemens Medical, Mentor and Cora and other companies, following a new cancer…

FDA recommends tighter regulations on breast implants made by Four companies

The U.S. Food and Drug Administration released a set of recommendations on Friday for tighter regulation of breast implants made by Allergan, Siemens Medical, Mentor and Cora and other companies, following a new cancer study released last month that found a cancer linked to one of these implants in the U.S.

The FDA set standards for the most popular brands of breast implants made by the four companies that produce nearly two thirds of breast implants sold in the U.S. Of the 120,000 women who received implants in the United States in 2016, one percent had a cancer in the breast tissue, said the National Institutes of Health. In 2017, one in 5,000 cancers detected from the mammograms of women who have had implants were breast cancer, said the NIH.

Allergan said on Friday that it believes a new mammogram test, known as whole breast tomosynthesis, can help identify those women who have tumors in breast tissue. The procedure is intended to help surgeons see the shape of a tumor in the breast tissue and remove more cancerous tissue without removing the entire breast.

“This works for a procedure that currently involves removing more than 90 percent of the breast tissue,” said Allergan CEO Brent Saunders, in a call Friday morning with investors. The FDA will use the diagnostics to determine whether or not women are truly at increased risk and can then tell physicians how to evaluate those women.

Saunders and other company executives argued that increased adoption of the new, less invasive method of breast tissue removal could mean a number of benefits, such as decreasing breast cancer risk, breast cancer loss, reduction in recovery time, increased breast size, and reduced time between surgery and implant return.

“We are looking at it very carefully, we are engaged, and we do think the evidence will be very robust,” Saunders said. “We have a lot of confidence in the science and in our judgment.”

In a letter to doctors, The FDA said that the manufacturers should not ship any of their devices, including those sold in the U.S., overseas without clearance from the U.S. agency.

Allergan, Siemens Medical, Mentor and Cora should also increase the warnings on the labels of all of their products to include specific information about how to spot whether or not breast implants can be a risk factor for cancer, according to the FDA. The FDA also said the companies should include specific instruction on reporting instances of silicone breast implant ruptures, reporting of body changes after implantation, and other disease risk information for customers and physicians.

“These recommendations are important steps toward ensuring that consumers have accurate and timely information when choosing a breast implant that is right for them,” FDA Commissioner Scott Gottlieb said in a statement. “These recommendations will help ensure that patients are able to make an informed decision about the implant that is right for them.”

In their notice to doctors, the manufacturers argued that the increase in the average age of a woman to receive a breast implant has resulted in more women with conditions like aortic stenosis, vascular disease and psoriasis that could indicate implant rupture. However, doctors and scientific groups have found that women should use caution when predicting which women at risk of implant rupture should receive breast implants, based on their medical condition.

The FDA cited data from the U.S. Centers for Disease Control and Prevention that found that among women who have received breast implants, most have not had a complication for at least 10 years after the implants were placed, but there is considerable variability in the number of occurrences.

The FDA said additional information could be obtained by an audit of the manufacturers’ manufacturing facilities in 2015. In addition, the agency will look at whether voluntary information available through the manufacturers’ websites gives consumers enough information.

Breast implants can cause scar tissue, pain, swelling, infection, and changes in texture and feel in the breasts. Once implants are implanted, patients should let their surgeons or an independent ophthalmologist to take photos of the area prior to any additional procedures and mammograms are recommended.

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