Charlotte FDA consumer rep. advocated for breast implant recall months ago

Charlotte resident Rachel Brummert says the worldwide recall of Allergan textured breast implants is long overdue. 

"I wondered why it was still on the market to begin with," said Brummert.

Brummert served as a consumer representative for the Food and Drug Administration. She recommended, unsuccessfully, that the FDA shelve the textured implants at a panel in March. At the time, the implants had been banned by dozens of other countries, she said. 

"When I saw the data from the FDA and I saw the data from the manufacturers," she said, "I saw that there was a very high incidence of a man made cancer that these breast implants were causing and that's concerning to me."

Brummert says she was happy to see the FDA recommend the recall this week, which the company voluntarily announced. She is now urging the FDA to create a central online registry where patients can report their symptoms. 

The FDA requested the recall after conducting an analysis of nearly 600 patients with breast implant-associated anaplastic large cell lymphoma. They found nearly 85 percent of those patients had Allergan breast implants at the time of diagnosis. 

Worldwide there have been 33 deaths tied to the rare cancer.

Tanya Ricardo got breast implants in April. She is one of many patients across the country who now have questions.

"The first thing I thought about was 'oh wow,'" said Ricardo. "Should I be concerned?"

The company is recalling unused implants from plastic surgeons but is not telling women who already have them to get them removed.

Not everyone agrees with that recommendation. 

"I don't think it's correct for a company to say: 'You can't put these in anymore they're unsafe but it's OK girls, if you have the implants in just don't worry about it,'" said plastic surgeon Dr. Franklin Rose.

"The FDA does not recommend removal for patients without symptoms due to potential risks," said Dr. Jeff Shuren with the FDA.  "We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted."

Symptoms include pain, swelling and fluid accumulation around the implant.