Our office has answered inquiries from a number of patients who are concerned that their implants are causing them cancer since an article appeared this spring in the New York Times. Many physicians have asked me the same question and I sent the following letter to Mercy Obstetric and Gynecologic surgeons to address and answer some of the common concerns. I wish to share the letter with you which may alleviate some of your concerns and also tell you what to watch for yourself.
16 June 2017
Dear OB-GYN physicians:
A Mercy OB-GYN recently asked me about this new breast lymphoma “thing”. This is becoming more recognized and is referred to as BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma). The physician became aware of this when a breast implant patient asked about an article that appeared one month ago in the New York Times entitled: Breast Implants ‘Gave Me Cancer’. To make it more pertinent, the highlighted patient in the NYT article is a young lady from Herman, Missouri who was diagnosed at age 33 with breast cancer, underwent mastectomies and textured implant reconstruction here in St Louis, and 6 years later was diagnosed with BIA-ALCL.
This problem is very pertinent for OB-GYNs as you examine a lot of breasts with implants and you are often the first line when patients have questions or concerns about their implants. An early diagnosis of BIA-ALCL is treatable and therefore it is important to consider this diagnosis when there are specific signs and symptoms.
The textured implant seems to be a key and I stopped using these implants at least 10 years ago. So what are the numbers you need to know?
- 10 million women have implants
- The FDA is aware of 359 cases BIA-ALCL reported to them by US plastic surgeons. The first reported cases were ~2011
- There are 1400 cases/year of ALCL and is extremely rare in breast tissue not in contact with a textured implant
- Most of the BIA-ALCL cases occur about 8 years after implantation (range 2-28 years)
- Almost all the cases have been associated with textured implants and the current risk of BIA-ALCL in women with textured implants is 1:30,000
- Almost 90% of cases are cured with surgery alone. There is a 93% 3-year cure rate with implant removal and capsulectomy (the removal of scar tissue which forms around all implants)
- Nine patients have died from BIA-ALCL or from treatment for their lymphoma (chemo, BMT, etc.). None of these patients received complete surgical excision of the cancer and there was a significant delay in diagnosis and treatment.
So, as a physician, what signs and symptoms should get your attention? The most common presentation is a late non-traumatic non-infectious swelling of a breast with an implant in place especially if the implant has a textured/rough surface often referred to as a “gummy bear” implant. It can happen at any time after either breast augmentation or reconstruction. If this patient shows up in your office, an ultrasound guided fluid aspiration should be performed and the cells sent for CD30 immunochemistry, cytology, and flow cytology. This lymphoma is not picked up on routine pathology or routine H&E stains. Or better yet, just send them to a plastic surgeon for work up of their swelling.
Referral to a plastic surgeon is appropriate as treatment is removal of the implant and TOTAL capsulectomy. Plastic surgeons are further required to report these cases to a national patient registry, the FDA, and the MD Anderson Medical Center where these cases are being collected.
Feel free to give me a call if you have questions. I have info on my website blog (drfrancel.com) which I wrote 2 years ago when the issue first came to light. It is still pertinent or check out plasticsurgery.org or fda.gov.
Hope this information helps.
Thomas J Francel, MD, FACS
Chief of Plastic Surgery Mercy St Louis