Medical Alert

FDA review indicates possible association
between breast implants and a rare cancer:
Click Here to Read Report from FDA.gov

Comments from Dr. DellaCroce:

Here is what we know…..

An estimated 5-10 million women worldwide have received breast implants. According to a report released Jan 26th, , there is a possible link between having breast implants and developing a rare type of lymphoma called anaplastic large cell lymphoma (ALCL).

This data comes from the information that has been progressively collected since silicone breast implants were pulled off the market years ago. The bulk of data has suggested that they are safe and so they were ultimately reintroduced into the market in recent years in the U.S.

The information was gathered from 18 published reports over 13 years involving 34 total cases, 11 reconstructions, 19 augmentations, and 4 women with implants for undetermined reasons. Symptoms in these women included pain, lumps, swelling, or asymmetry of the breasts long after their surgical sites had healed. Their doctors most often only found fluid around the implant in the space confined by the capsule. (When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, the ALCL was generally found adjacent to the implant itself and contained within the fibrous capsule.)

No invasion into breast was typically found and the patients were treated with removal of the implants and capsule, radiation and/or chemotherapy. 19 cases had outcomes data with 14 patients showing no evidence of remaining disease at followup but that was limited. It cannot be presently determined if these patients have a different prognosis than those with ALCL developing from other causes which is favorable is certain situations and less favorable in others.

Statistical analysis showed that in patients with ALCL the odds of having a breast implant were 18.2 times higher than in other types of lymphoma patients, meaning that the probability of developing ALCL was greater in women with breast implants than those without

One theory as to the cause relates to the fact that silicone from ruptured and even intact implants has been found in nearby breast tissue. This silicone may chronically stimulate the immune system’s “T cells” and thereby induce lymphoma.

The FDA’s formal position on all of this is that because the risk of ALCL appears very small, implants should still be considered safe overall.

So what should you do…………..?

If you are considering having implants, be aware of this issue.

If you have implants already, don’t panic. There are no recommendations to change your current care.

You should:

• Monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. For more information on self breast exams, visit Medline Plus: Breast Self Exam.
  
• Get routine mammography screening.
  If you have silicone gel-filled breast implants, getting periodic magnetic resonance imaging (MRI) to detect ruptures may be recommended by your health care provider.

The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

Use of breast implants should always be approached with careful consideration of the benefits and potential risks. Due to the rarity of ALCL, the small number of reports, and the incomplete and limited data from these reports, more information is needed to fully understand the possible link between breast implants and ALCL. Until then, knowledge, understanding, and prudence on both the patient and physician side are important.

Dr. D