FDA Calls for Recall on Textured Breast Implants | RadNet Inland Empire
button-radnet
13 August, 2019

FDA Calls for Recall on Textured Breast Implants

Last month, Allergen issued a world-wide recall on their textured breast implants. This followed a discovery by the FDA of a direct link between the implants and a rare type of cancer. According to FDA Principal Deputy Commissioner Amy Abernethy, Allergen’s textured implants “appeared to be directly linked to significant patient harm, including death.”

While the link between the textured implants and cancer was first identified in 2011, it was only recently that there has been a significant increase in known cases of Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), according to the FDA. This is not a type of breast cancer, but a cancer that affects the immune system. Slow growing, this cancer develops in the scar tissue surrounding the breasts and can usually be treated successfully if it is detected early and the implants are removed.

Allergen’s “Biocell” implants feature a textured surface, meant to prevent “slippage” and to minimize scar tissue. In the United States, only 10% of implants used are the textured devices. Most implants used in the U.S. have a smooth surface. Even so, the FDA reported 573 cases of BIA-ALCL worldwide with 33 deaths resulting from the cancer. 481 cases of that number have been directly attributed to the Allergen Biocell implants.  It is likely that the FDA will recall other textured implants by other manufacturers.

Though the risk of developing cancer from textured implants is higher than it is for smooth implants, it’s still pretty rare overall. Women who have textured implants are advised to talk to their doctors and not necessarily run out and remove the implants right away. They should monitor themselves for any symptoms, including pain, swelling, or anything abnormal.

At RadNet and Breastlink, we strive to keep all of our patients knowledgeable about the issues that matter to you most. We believe that informed patients live healthier lives and we remain committed to partnering with you on your healthcare journey.

Los Angeles Times, July 24, 2019; USA Today, July 24, 2019

13 August, 2019

infobox-arrow

Add new comment

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.