The Breast implant manufacturers may soon have to stamp the products with warnings of cancer risk and other dangers and complications if the Food and Drug Administration has its way.
“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 that would be included in the packaging would include the 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, like the fact that breast implants have been associated with the risk of developing the cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
That is not a type of breast cancer, but a cancer of the immune system.
A proposed patient-decision checklist that would appear in an informational booklet or brochure 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 BIA-ALCL and risk of implant rupture, among others,” the FDA stated.
The checklist would also advise patients to drill their surgeons about their experience, education, training and credentials.
The FDA has also proposed updating recommendations for patient screenings for those with with silicone gel-filled breast implants to check if the device has ruptured.
Current approved labeling recommends MRI screenings for patients starting three years after surgery and every other year after that. But the new recommendation advises that those without symptoms be screened using either ultrasound or MRI at five to six years after getting implants and then every two years after that. The more lax testing schedule is based on data showing that rupture rates are higher five to six years after surgery, and the FDA’s “awareness of poor patient compliance with the existing MRI recommendations.”
“By proposing updates to the recommendations based on current science and other information, the FDA hopes to make it easier for patients to comply with these new recommendations,” the agency said.
The proposed rules in the FDA’s draft guidance aren’t laws yet and the agency is welcoming public comment before putting a final policy in place.
No comments:
Post a Comment