PALM BEACH COUNTY, Fla. — Women are calling it a 'life saving' recall. One of the largest breast implant makers, Allergan, is recalling Biocell saline-filled and silicone-filled textured breast implants and tissue expanders worldwide.
The Food and Drug Administration said Wednesday it has asked Allergan to issue the recall after discovering the devices are linked to a higher risk of a rare type of cancer.
The FDA said that there has been a significant increase in known cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer that affects the immune system.
Stuart realtor Cathy Carr had her textured implants removed after she says they caused her to become very sick.
Carr says, "All of a sudden my face was swollen, I had blisters all over my mouth, couldn't get out of bed for four days. my body hurt so bad I didn't know what to do."
Her blood test came back positive for Lyme disease and lupus. Carr started researching and joined an online group of women with similar symptoms, which is when she decided her implants were making her sick and had them removed.
"I started to feel better immediately, says Carr, I would say within three months of explanting, I was 75-80 percent better."
The real estate agent says she is one of the lucky ones, she didn't have the kind of cancer linked to the allergen textured implants. She says the recall is a victory for women who were often dismissed by the medical community.
"This decision is from a long list of dedicated, tenacious advocates searching for the truth," says Carr.
Two women from Florida spoke at the FDA hearings in March. At that time the agency did not move to recall the devices, even though more than two dozen countries, including France, Canada, and Australia, already had done so.
According to the FDA, there are 573 cases of this type of large cell lymphoma, including 116 cases identified since February. Of these known cases, 481 are attributed to Allergan implants, the FDA says.
Thirty-three women have died of this type of cancer and the FDA says of the 13 deaths in which officials identified a manufacturer, 12 had Allergan implants when they were diagnosed.
The FDA says if you have the textured implants, but don't have symptoms then there's no need to have them taken out.
Women who have had to make that tough decision have a different message for women with breast implants.
"Look at what the symptoms are. Be mindful that this can happen to you. I thought this couldn't happen to me and it absolutely did," says Carr."