Ethylene Oxide/Sterigenics Updates

FDA Warns of New Cancer Risk from Breast Implants

Breast_implants_in_hand_01-300x200The FDA recently issued a safety communication warning about a link between breast implants and certain cancers that can develop in the scar tissue around implants.

This new agency warning does not include Breast Implant-Associated Anaplastic Large Cell Lymphoma which has previously been linked to certain Allergan textured breast implants. Those textured implants were recalled after being linked to 600 illnesses and 33 deaths.

Now the FDA is warning women about squamous cell carcinoma (SCC) and lymphomas that are linked to all types of implants, regardless of whether they are saline or silicone filled, smooth or textured. These cancers form in the capsule, or scar tissue, around the implant. Currently, the FDA is aware of 20 cases of squamous cell cancer and 30 cases of lymphoma in the capsule around breast implants. The agency issued this statement as part of its safety communication, “While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature. Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.”

Moreover, doctors do not yet know why these cancers form. Some theorize that scar tissue around the implants may become inflamed, causing fluid to build up and damage cells. This could potentially lead to cancer in the fluid, and eventually in the scar tissue itself. Another theory suggests that the implant material may cause the immune system—sensing a foreign invader– to overreact and cause cancer to develop. However, as of now, no one really knows.

Breast implants are common in the United States. Estimates of the number of American women with breast implants range from 1 to 3 million. They have been linked to some health issues:

  • Autoimmune disease
  • Lymphoma
  • Joint pain
  • Bleeding
  • Fluid accumulation
  • Pain associated with tight scar tissue
  • Implant leakage or rupture
  • Poor scarring
  • Hematoma
  • Infection

Cancer linked to breast implants is an emerging concern. If you have breast implants, please look out for these symptoms:

  1. Swelling
  2. Pain
  3. Lumps
  4. Skin changes

At this time, the FDA does not recommend changing your standard medical care, removing your implants, or rushing to the doctor. They do advise monitoring your breasts once a month for signs of any changes, especially around the area of the implants. If you notice any changes like the ones listed above, see your plastic surgeon or health care provider. And if you do have a problem with your implants, file an online report with MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

To read the complete FDA warning, click here.

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