Category Archives: Breast Reconstruction

What Women Need to Know About Breast Implants: FDA Backgrounder

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:
https://www.fda.gov/consumers/consumer-updates/what-know-about-breast-implants

#breastreconstruction #mammography #breastimaging #breastimplants

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The draft guidance, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, provides recommendations for the form and content for certain labeling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This draft guidance will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467.

Submit Comments

https://www.cnn.com/2019/10/23/health/breast-implants-fda-boxed-warning-bn/index.html

Textured Breasts Implants Withdrawn World-Wide

At the request of the federal government, the manufacturer of textured breasts implants has withdrawn the product world-wide over cancer concerns.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.
https://www.nytimes.com/2019/07/24/health/breast-implants-cancer-recall.html?action=click&module=Top%20Stories&pgtype=Homepage

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.
https://www.icij.org/investigations/implant-files/canada-netherlands-halt-sales-of-cancer-linked-breast-implants/?fbclid=IwAR2QzIwU4AVbdb8H0BGHVxeX93hA5YSEw_qzMM_pVQW7MdSi348UlmwLO60

Over or Under the Muscle: The Debate Over Where to Place Breast Implants

Increasingly, doctors are placing breast implants over not under the muscle for women who are thinner, very active and athletic, to minimize a problem called distortion when the implants move around. We address this issue in our book; some doctors, however, say that positioning implants over the muscle gives a more unnatural look. If you are a weight lifter, boxer or very athletic, thinner woman considering implants, this is an important issue to discuss with your plastic surgeon.

NYTIMES.COM
The technique places implants on top of muscle, instead of under it.