Proposed regulations from the federal Food and Drug Administration address problems with breast implants and call for more frequent screening, beginning at 5-6 years after surgery and every 2 years after that, for women with the devices.
Here’s a good backgrounder from the FDA on the issues:
#breastreconstruction #mammography #breastimaging #breastimplants
Following testimony by women last spring about problems caused by breast implants, the FDA will require new warning labels on the devices, and defines risks and problems with them. The public has 60 days to comment on the new regulations. Here’s how to comment and the FDA notice issued today:
The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warning
- Patient decision checklist
- Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
- Silicone gel-filled breast implant rupture screening recommendations
- Patient device card
When final, the recommendations in this guidance will supplement or, in some cases, replace recommendations in the FDA’s Saline, Silicone Gel, and Alternative Breast Implants guidance, issued November 17, 2006.
This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.
Far too many women remain unaware of all the implications of their breast cancer surgery and are unhappy with the scars they live with, a study shows. It’s very important to discuss with your breast surgeon the type of incision he/she will use in your operation.
At the request of the federal government, the manufacturer of textured breasts implants has withdrawn the product world-wide over cancer concerns. The federal Food and Drug Administration, which requested the action, said women with the implants who do not have problems do not need to remove them.
For those of you who like to find info using your phone, there’s a good new free app from a leading plastic surgeon with loads of helpful info. The link: https://www.facebook.com/BreastAdvocate/
Pending federal legislation would require health insurers to cover compression breast sleeves and other medically necessary help for breast and other surgery patients. Here’s a link with background and ways to support the bill. https://lymphedematreatmentact.org/
The list of countries to ban textured breast implant grows, while they remain on the market in the United States. Women wanting to avoid the risk of lymphomas linked to textured implants have choices: Staying flat; autologous breast reconstruction; and smooth breast implants.
See this link https://www.facebook.com/groups/295420417294192/to follow latest developments about two days of hearings by FDA on breast implants. Key issues include risk of lymphoma from certain types of breast implants; improvement of followup of patients with breast implants; and model practices regarding patient consent.
Robotic surgery, now common for some operations, has not been as successful for breast reconstruction and other procedures, the federal Food and Drug Administration warns.