Women who have breast implants need to know that the risk of complications and having them removed or replaced grows with time, the FDA (Food and Drug Administration) announced. 20% of women who received breast augmentation implants will have to have them removed within 10 years of the procedure. For breast reconstruction the figure could be as high as 1 in every 2 within ten years.

The FDA has issued a report after reviewing the latest clinical and scientific data for silicone gel-filled breast implants. The Agency stresses that gel-filled breast implants are effective and safe when they are used as intended. However, it is vital that patients are told about the risks before undergoing any augmentation or reconstruction procedure.

Below are some highlighted details from the report:

  • The longer a patient has silicone gel-filled implants, the higher her risk of experiencing complications and needing to have them removed and/or replaced. 1 in every 5 patients who had a breast augmentation procedure will need to have them removed within ten years.
  • Up to 1 in every 2 women who underwent breast reconstruction will have to have them removed within ten years.
  • The most common complications and outcomes are:

    – Capsular contracture – the area around the implant hardens
    – Additional surgeries
    – Removal of the implant(s)
    – The implant ruptures
    – Wrinkling
    – Asymmetry
    – Infection
    – Pain
    – Scarring

  • Complication risks have not changed since breast implants were approved
  • According to preliminary data, gel filled implants do not appear to cause:

    – Breast cancer
    – Connective tissue disease, e.g. rheumatoid arthritis
    – Fertility problems

    However, larger longer-term studies are needed to confirm that there is no risk.

Preliminary safety data in the report comes from post-approval studies carried out by Allergan and Mentor, two breast implant makers. It also includes a summary and analysis of undesirable side effects (adverse events) that the FDA has received over the years, as well as a comprehensive analysis and review of recent articles published in academic journals on the safety and effectiveness of silicone gel-filled breast implants.

Silicone gel-filled implants for breast augmentation were approved by the FDA in November 2006 – for females aged at least 22 years. The FDA also approved the product (on the same date) for breast reconstruction for women of all ages.

One of the conditions of approval stipulated that the two manufacturers carry out six post-approval studies focusing on the long-term performance and safety of silicone gel-filled implants.
Allergan and Mentor have liaised closely with the FDA. Both companies say that following the women who underwent the procedure is difficult. The FDA and the two companies are working together to address this.

Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, said:

“The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms. Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

An expert advisory panel is meeting later this year to discuss ways of improving breast implant post-approval studies.

The FDA advises that patients who have undergone silicone gel-filled breast implants, and doctors do the following:

  • Patients should remember to continue going to their routine follow-up appointments, including having routine MRI scans that can detect silent rupture
  • Women need to know that breast implants are not designed to last for life. Also, they carry with them several risks and complications, including rupture, capsular contracture, and the need for further surgeries.
  • Look out for any change – women who develop any unusual symptoms should tell their doctor immediately. Serious side effects should be reported to Medwatch and the implant manufacturer (Telephone: 800-332-1088).
  • Continue participating in studies – any patient who is taking part in a manufacturer-sponsored post-approval study should continue to do so. These studies are vital for assessing long-term complication rates.

The FDA explains that its report is part of its effort to make sure that all women who had undergone or are considering silicone gel-filled breast implants are fully aware of all the potential outcomes and complications.

Written by Christian Nordqvist