For Patients Concerned About Textured Breast Implants

You may have heard recent media reports regarding a new type of cancer or tumor that occurs around textured breast  implants. The FDA recently updated information regarding this disease (Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL)). The American Society of Plastic Surgeons is working closely with the FDA in monitoring this disease.

The FDA has issued a statement that they do not recommend the removal of textured breast implants. They do want to make sure that surgeons are fully explaining the current issues with patients before they make their decision. The current statistics give this a lifetime risk of occurring as 1 in 30,000 with textured breast implants. 84% of ALCL cases have occurred with Allergan textured implants. Their incidence appears to be about 1:3000. Mentor textured implants are closer to 1:82,000, and the most recent statistics I have seen show Sientra textured implants to be between 1:85,000 – 1:200,000. This tumor tends to occur within the scar capsule that forms around the breast implant. This is not breast cancer. We can minimize the risk of this ALCL forming by removing the textured implant and the entire associated scar around it. At that point, we could put a smooth implant back in. There are, however, risks associated with smooth implants as well, such as a significantly higher incidence of Capsular Contracture, or hardening of scar around them, in some situations, up to 10X higher that textured, and these implants have a much higher incidence of shifting out of position. Any surgery has a risk of developing infection. All of these problems would be surgical problems that would have to be corrected in the operating room. The question then becomes whether it is worth taking on all these additional risks to minimize our risk of 1:3,000 – 1:200,000 developing this ALCL. If it is caught early, it is curable in almost everyone. Since it is not FDA recommended that these implants come out, currently most insurance companies are NOT covering the procedure to remove them.

ALCL tends to appear 8-12 years after surgery, but it can occur as early as a year and as far as 20 years out. It typically presents as a fluid collection or swelling around the breast, or your breast swells up for no apparent reason. It could also appear as a mass that forms around the implant and rarely can appear as a rash that forms around the breast. If someone presents to me years after surgery with a fluid collection around the implant, the treatment of choice is to pull some of that fluid off and send it to the lab to be tested. If it does come back positive, the recommendation would be to get a PET/CT scan to look for any spread, and then remove the implant and the associated scar if it is confined to just the scar. This is curative in the vast majority of patients. In my 29 years of practice, I have not seen a single case of ALCL, but I have had several women present with fluid collections that I’ve tested, and they have all been negative.

I am unable to reach out and contact or call all of my patients that I have placed implants in over the years because of privacy issues. But I strongly encourage any women who are concerned, that they contact my office. We can let you know what type of implants you have. I would be glad to see any of you in consult in the office to discuss your options. You can also obtain additional information about BIA–ALCL by consulting the American Society of plastic surgeons website at www.plasticsurgery.org/ALCL. And of course, I’m always happy to answer your questions personally.

Sincerely,

Richard R. Orr, Jr., MD

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