When Breast Implants Fail: Women Recount Side Effects as Food and Drug Administration Investigates - NBC 10 Philadelphia

When Breast Implants Fail: Women Recount Side Effects as Food and Drug Administration Investigates

Complications from a specific type of breast implant, known as textured shell-style, may be causing severe side effects for some women. A federal agency is now investigating.

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    NEWSLETTERS

    Risks of Breast Implants

    One woman is sharing her story after her implants made her sick. Now, she wants other women to listen to the warnings.

    (Published Thursday, April 25, 2019)

    What to Know

    • 318,000 people had breast implant surgery in 2018, up from 300,000 in 2017.

    • Breast implant surgery is the most popular cosmetic surgery in the country.

    • The Food and Drug Administration held hearings in March on a textured shell implants, which have been banned in Europe.

    UPDATE: The Food and Drug Administration ruled May 1 to allow a type of breast implant linked to a rare form of cancer to stay on the market. But the FDA said women should receive more information about potential risks when considering the implants. 

    One in five women who have breast implants have them removed within 10 years of plastic surgery, which is the most performed cosmetic procedure in the United States.

    Debbie Shain, a breast cancer survivor from Voorhees, New Jersey, is one of them. She had explant surgery recently to remove two implants she had following a double mastectomy.

    "I was so sick I felt like I was going to die," Shain said. "I was bedridden. I couldn't leave the house."

    At first, she believed her joint pain, mental confusion and constant fatigue might have been Lyme disease. But she found out the effects were caused by complications from her implants.

    A Food and Drug Administration panel ruled last month after two days of hearings that more information is needed on the risks that breast implants pose for women.

    But the FDA did not agree to restrict use of a certain type of implant that some have blamed for the effects Shain describes. 

    She used an implant with a textured shell, which is the type that the FDA is in support of better labeling and informed consent but not an outright ban — yet.

    "Textured breast implants develop scar tissue to stick to the implant, making them less likely to move around inside of the breast and become re-positioned," according to the American Society of Plastic Surgeons.

    Dr. Steven Davis, a plastic surgeon in Cherry Hill, New Jersey, said the federal agency could eventually follow in Europe's footsteps and ban the "textured shell" implants. 

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    But even if the FDA does, Davis said the effects Shain has experienced are rare among the roughly 300,000 women who get breast implants each year.

    "The subsection of patients that are really feeling ill and may have a direct correlation to a breast implant is very, very small," Davis said.

    That minority, however, may be as confused as Shain was, however, if they can't figure out why they feel ill and confused, she said.

    "There are thousands of other women walking around, walking around just like me," Shain said. "I would like women to see this and say that's how I feel."

    To report a problem with breast implants or find resources on complications from the plastic surgery, visit the FDA's website. Here is a direct link to the federal agency's page on breast implants.