Breast practices FDA wants warning labels on implants sold in U.S.
Dead West Point cadet left warning
Breast implant manufacturers may soon have to stamp their products with warnings of cancer risks as well as other dangers and complications if the Food and Drug Administration has its way.
The federal agency released new guidelines Wednesday that propose a warning and a patient decision checklist on the label in order to ensure women are armed with information about the benefits and risks of implants.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the FDA said in a release. “They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information.”
The new recommendations are meant to help guide conversations between patients and doctors.
The warning to be included in the packaging would include a caution that breast implants are not lifetime devices, that the chances of developing complications increase the longer a patient has the implants, and that the devices may be associated with symptoms like fatigue or joint pain. It would also warn against more serious problems; breast implants have been associated with the risk of developing the cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system.
A proposed patient decision checklist would inform patients’ consultations with surgeons. “A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIAALCL and risk of implant rupture, among others,” the FDA stated.
The checklist would also advise patients to grill their surgeons about their education, training and credentials.
The FDA has also proposed updating recommendations for patient screenings to check for ruptures.
The four-day search for a missing West Point cadet has come to a tragic end.
The body of U.S. Military Academy Cadet Kade Kurita (inset) was discovered late Tuesday evening in the basement of a campus building, reported Military.com.
More disturbing is that before the 20-year-old California native disappeared, he posted a note referencing his suicide plan on social media app Snapchat, according to an anonymous
Army official.
The official added that Kurita fatally shot himself; a West Point statement noted the cause of death is under investigation, although foul play is unlikely.
West Point reps don’t believe the junior intended to hurt others, as he left behind his gear and Kevlar helmet.