On July 25th Food and Drug Administration (FDA) issued a statement regarding a rare cancer linked to a specific kind of breast implant.
This FDA safety communication is for textured breast implants and tissue expanders used for breast augmentation and/or reconstruction. The kind of cancer linked to these specific implants is a rare kind of lymphoma called breast implant associated – anaplastic large cell lymphoma (BIA-ALCL).
The safety recall was a response to a worldwide report on medical devices. The report described 573 cases of BIA-ALCL including 33 deaths secondary to the lymphoma. Of these 573 patients with the lymphoma, 481 had textured breast implants at the time of diagnosis. Allergan, an Irish pharmaceutical and biotech company manufactures these textured implants.
Read on to find out what to do if you have breast implants or are considering having them.
What you should know?
Textured vs. Non-textured Implants:
Textured implants have a teardrop shape to mimic natural breast shape and contour. The outside surface is roughened so there is increased scar tissue formation, enabling the implant to stay in place. Considering the shape of the implant, if it moves around, it will distort breast shape and hence texture helps the implant to stay in place.
Smooth or non textured implants – are softer, round in shape and have some degree of flexibility of movement within the new breast envelope. Since they are uniformly round, movement of these implant does not distort breast shape and form.
What is BIA-ALCL?
BIA-ALCL is NOT breast cancer but is a rare kind of lymphoma (cancer of the immune system) that has been linked to the textured implants. BIA-ALCL does not begin in the breast tissue but in the scar tissue (capsule) and fluid around the implant.
BIA-ALCL is NOT linked to ALL kinds of breast implants, but only to the textured ones. Textured breast implants are more common in Europe, and make up about 10% of all implants in US. According to FDA, Allergan’s textured implants account for less than 5% of women with breast implants in US.
Symptoms of BIA-ALCL usually appear 10-12 years after the implant placement. They may be quite non-specific and may include swelling, pain, mass, breast firmness, and distortion in shape of breast.
In most patients, BIA-ALCL has a good prognosis after the implant and the scar tissue surrounding the implant is surgically removed; however, some patients may require treatment with chemotherapy and/or radiation therapy
What should you do if you have breast implants?
First and foremost – Do Not Panic. Work through this calmly – it’s a kind of implant not commonly used in US and the cancer associated with it is a rare one.
Look through your discharge summary or any medical records you have saved from your procedure. There is usually a sticker on them with information about the type of implant used, unique implant identifier number and implant manufacturer. You can also call your surgeon’s office and request surgical records, which will provide you with accurate information.
What should you do if you have the recalled implants?
Currently, FDA is not advising for everyone with the textured implants to have it removed. If you have any signs or symptoms of swelling, pain, abnormal mass felt in the breast area, firmness or abnormality of breast shape and form, you should consult your health care provider. Typically, some of these symptoms appear 10-12 years after implant placement in most patients and are simply related to the presence of implant, a foreign body, rather than BIA-ALCL. A consultation with your surgeon can put your mind to rest. In case of any worrying symptoms, the textured implants and surrounding scar capsule should be removed.
What if you are considering breast augmentation using implants?
If you are considering breast implants, have a fair discussion about risks and benefits of the procedure with your surgeon, about choice of implants, short and long term side effects and the association of BIA-ALCL with textured implants. You can read more about implants using the references at the end of this article, which will help you make an educated decision regarding these options.
Please note that FDA has ONLY recalled Allergan’s textured implants – there are other manufacturers of textured implants and your surgeon may have an inventory of them. FDA is continuing to monitor other companies and other kinds of breast implants, including the smooth ones, for any association with BIA-ALCL.
If you have questions regarding breast implants, feel free to put them under comments and I will respond to them or send me a personal email at drshaheen@voicebowl.com
Resources:
- List of Allergan recalled breast implants.
- Breast Augmentation – Risks and benefits: https://www.mayoclinic.org/tests-procedures/breast-augmentation/about/pac-20393178
Photo credit:
Smooth and textured Breast Implants Used for Augmentation/reconstruction – www.dr-spitalier.com/interventions/interventions-sein/aug…
