Category Archives: Uncategorized

FDA Calls for Warning Labels for Breast Implants

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The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling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This draft guidance will be open for public comments for 60 days, through December 23, 2019, at under docket number FDA-2019-D-4467.

Submit Comments

Free Mammograms, Pap and Nurse Navigation Help

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.

Canada Latest Nation to Ban Textured Breast Implants

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.

Dense Breast Resources

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:

  2. New federal law:
  3. National Cancer Institute:…/what-women-should…