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FDA Taking A Closer Look At Breast Implant Safety

1 year, 3 months ago

5407  0
Posted on Apr 08, 2019, 5 p.m.

Countless women have had breast implants which are either silicone sacs filled with salt water or silicone gel for cosmetic or reconstructive purposes; women, or men for that matter, can get breast implants to make their breasts look fuller and/or bigger. These procedures can be done for cosmetic reasons or for reconstructive purposes such as after mastectomy for breast cancer.

Questions regarding the safety of breast implants are gaining new attention from the US FDA as thousands of women are saying their implants are causing debilitating joint pain and fatigue; claims such as these have been dismissed by implant makers and doctors who believed such concerns had been resolved about 10 years ago, but this does not appear to be the case.

The FDA has warned that two breast implant makers have failed to conduct adequate long term studies on their implants’ effects on women’s health that were a condition of approval; these implants could be taken off market if the companies don’t fulfill their requirements according to the FDA.

In a statement the US FDA acknowledged that: “...breast implants and other implantable devices may contain materials that can affect health…” “..growing body of evidence suggests a small number of patients may have biological responses to certain types of materials…” which includes “...inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with quality of life…”

The US FDA is investigating to collect more information “ further our understanding of medical device materials and improve safety of devices for patients…” One of the materials under scrutiny that will be looked at is silicone which is being used in breast implants. A two day meeting has been scheduled to hear from the researchers, patient advocacy groups, and manufacturers regarding breast implants. One of the problems to be discussed is the is the occurrence of the uncommon cancer anaplastic large cell lymphoma which has been detected in 457 with breast implants so far, implant removal usually eliminates the disease but some have also needed chemotherapy, and 17 deaths have been reported, according to the FDA.

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