This is an emerging story about a possibly dangerous medical device that we find interesting.
Researchers are finding a rare malignancy of the breast associated with a particular type of breast implant. The disease is anaplastic large-cell lymphoma (ALCL) and the Food and Drug Administration (FDA) has noted 359 reports of possible breast implant-involved ALCL and nine deaths.
This rare T-cell cancer involves the cells of the immune system. It is characterized by an abnormal growth of the T-cells with a strong expression of protein, and cytokine receptor CD30.
The disease has been found specifically around the site of textured breast implants.
The FDA stops short of saying that type of breast implant causes cancer. It does say it’s establishing a registry in collaboration with the American Society of Plastic Surgeons to study the issue.
Data collection could take 10 years.
The leading theory of causation is that the abrasive texture may cause inflammation that leads to this type of cancer on an average of eight years after implantation.
A textured implant looks cloudy when compared to a clear non-textured implant. The FDA says it doesn’t seem to matter whether the implant is filled with saline or silicone or whether the implant is for reconstruction or cosmetic reasons.
Surgeons choose a textured implant to reduce the rate of capsular contracture or a hardening around the implant. The texture is also thought to stabilize movement of the implant in the body.
If found in the early stages, ALCL is often curable and the first step is to remove the implant.
Another theory of causation is that bacterial biofilms may thrive around a textured implant that irritate the immune system with persistent inflammation. Biofilms grow in high humidity and have been found surrounding other implants such as transvaginal mesh.
Allergan, which makes textured breast implants, is studying the inflammatory and immune response to their product as well as bacterial biofilms.
Symptoms of ALCL include a fluid buildup around the implant, lumps in the breast or armpit or swelling. Draining the fluid and testing it for CD 30 will indicate lymphoma.
Worldwide there are about 10 million women with breast implants, the majority for cosmetic enhancement. Among those, 550,000 are placed per year in the U.S. Of these, approximately 70,000 textured breast implants are placed.
The FDA does not exactly issue a rousing endorsement of breast implants and their safety, though it says ALCL risk is low.
According to Australian regulators, the risk is one in 1,000 to one in 10,000 women with breast implants.
The “FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”