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The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling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This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.
Though it’s nearly 30-years-old, far too many women do not know about a federally-funded program that pays for mammograms, Pap smears and nurse navigation help for uninsured and under-insured women. Help spread the word and post a flyer somewhere _ on electronic bulletin boards, web sites, and other places women will see it at work, school and in their communities. http://www.bcccp.org
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.
A new large study finds a higher risk of blood clots in breast cancer patients taking tamoxifen and aromatase inhibitors, prescribed to prevent cancer recurrence. https://medivizor.com/view_article/24247177?utm_campaign=website&utm_source=sendgrid.com&utm_medium=email
Breast density — thicker tissue that make it hard to spot tumors on a mammogram — is an important issue and more than 30 states now require centers to tell women about. And a new federal law requires providers to tell women about whether their breasts are considered dense.
Here are some resources:
- New federal law: https://www.radiologybusiness.com/topics/policy/federal-law-breast-density-notifications-patient?fbclid=IwAR
- National Cancer Institute: https://www.cancer.gov/types/breast/breast-changes/dense-breasts
All women and men diagnosed with breast cancer should receive genetic counseling, the leading group of breast surgeons says. https://www.chicagotribune.com/lifestyles/health/sc-hlth-breast-cancer-genetic-testing-0227-story.html