Agency suggests boxed warning, checklist outlining potential harms, such as pain, fatigue, further surgery
WEDNESDAY, Oct. 23, 2019 (HealthDay News) — Before receiving breast implants, women should be told of the possible risks, the U.S. Food and Drug Administration says in a draft proposal.
The FDA wants breast implant makers to warn women that breast implants are not lifetime devices and that the risk for complications increases the longer a patient has the implant. Also, additional surgery may be required to treat the complications. Other possible complications include a risk for developing breast implant-associated anaplastic large cell lymphoma, as well as problems such as fatigue or joint pain.
In addition to a boxed warning, breast implant makers should include a checklist at the end of a patient informational booklet or brochure to help guide discussion when a woman is consulting with a surgeon, the FDA said. Along with giving patients the opportunity to review the specific risks for breast implants, the checklist should encourage them to ask about the surgeon’s experience, education, training, and credentials.
The draft guidance also includes revised rupture screening recommendations for patients with silicone gel-filled breast implants. Currently, magnetic resonance imaging (MRI) screenings are recommended beginning three years after implantation and every other year thereafter. The new guidance proposes that patients without symptoms undergo either ultrasound or MRI screening five to six years after implantation and every two years thereafter. An MRI is recommended for patients who have symptoms at any time or uncertain ultrasound results for breast implant rupture. Easy-to-understand ingredient information should also be included on breast implant labeling, the FDA said.
The proposal changes are now open to public comment.
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