Mounting Breast Implant Illness Reports Prompt Renewed Concern at FDA

Published on March 21, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) is taking another look at breast implant illness, amid mounting reports tying the popular devices to joint pain, severe fatigue, and other serious health problems.

Breast Implant Illness Reports Not Taken Seriously

Roughly 400,000 women receive silicone or saline breast implants in the United States every year during cosmetic enlargement procedures, as well as reconstructive surgeries following mastectomy.

While many believe the health controversy surrounding the devices was resolved over a decade ago, tens of thousands of women continue to report chronic fatigue, muscle pain, cognitive issues and other debilitating symptoms purportedly associated with breast implant illness.

According to the New York Times, other women have reportedly suffered connective tissue disorders, including rheumatoid arthritis and lupus, after receiving silicone breast implants.

The FDA has yet to find “any association between silicone gel-filled breast implants and connective tissue disease.” However, the regulator acknowledges that more extensive studies are needed to rule out possible link between breast implants and the reported complications.

Unfortunately, women who report breast implant illness are usually dismissed neurotic. On the rare occasion their symptoms are taken seriously, the ailments are written off as a coincidence that has nothing to do with breast implants.

Breast Implant Cancer Also On FDA Radar

Fortunately, that may be about to change.

Next week, the FDA will convene a two-day advisory panel meeting to discuss the risks potentially associated with silicone and saline-filled breast implants.  In addition to breast implant illness, the public hearing will also address the potential association between breast implants and anaplastic large cell lymphoma (ALCL).

According to the FDA, this rare cancer has occurred in over 600 breast implant recipients over the past decade, while at least 17 women worldwide have died from the disease. Most of the cases have occurred in women with textured breast implants, rather than those with a smooth surface.

ALCL is NOT breast cancer.  Rather, the disease is a type of non-Hodgkin’s lymphoma that develops in the scar capsule that eventually develops around breast implants. Symptoms may include:

  • Lumps
  • Swelling in the breast
  • Asymmetry around the breast implant after the surgical site is fully healed
  • Pain around the breast implant
  • Formation of a mass or masses in adjacent tissue.

The estimated incidence rates for breast implant-associated ALCL ranges from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000.

FDA Warns Breast Implant Makers on Post-Market Studies

Earlier this week, the FDA also sent Warning Letters to Mentor Worldwide LLC and Sientra, Inc. for failing to conduct post-market safety studies to assess the long-term risks of their silicone implants. The agency ordered those studies when the devices were approved, and suggested the companies’ silicone breast implants could be pulled from the market if they did not comply with the mandate.

“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies,” FDA Commissioner Scott Gottlieb, M.D said in a statement issued on March 19th. “We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.”

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