Silicone implants and cancer
Since possible links between silicone implants and cancer has been in the public discourse in recent days, here is an update to my earlier article.
The link between cancer and many other diseases and silicone implants was extensively studied in the 1990s, when the use of silicone implants was banned in the United States. No link between various diseases and silicone could be proven, and so silicone implants were also given a green light in the US.
In recent years, a crack has appeared in this blissful state, and it seems to be growing. In 1997, the first reports emerged of a very rare form of cancer in breasts with silicone implants. Since then, more reports have been made, but the risk seemed to be extremely low: 7-15 per 1,000,000 women with implants. It was a very rare tumor associated with lymphatic tissue (ALCL = anaplastic large cell lymphoma), which had a very good prognosis. What was and still is unusual about this disease is that it seemed to be associated only with textured implants. The implant filling—cooking salt or silicone—had nothing to do with the risk of developing the disease. This is not breast cancer but a tumor of the lymphatic tissue/cells.
European data published 3-4 years ago estimated the prevalence to be approximately 1/40,000 (per implanted woman aged 15-65). A year ago, Australian and New Zealand researchers estimated the prevalence to be 1/4500. The margin of error in the study was large, so the risk limits were set at 1/1000-10000.
Eight cases of ALCL have been reported in Finland. Over the years, more than 30,000 McGhan and Natrelle implants have been inserted.
To date, 672 cases of ALCL have been reported worldwide, 17 of which have resulted in death. It is estimated that breast implants have been fitted to over 10 million women.
In December 2018, the ANSM (Agence Nationale de Sécurité du Médicament, France) suspended the marketing authorization for Allergan's textured breast implants in the EU, Iceland, Liechtenstein, Norway, and Switzerland. As more than 50% of ALCL cases have been linked to Allergan's textured implants, the agency suspended sales and is investigating whether the CE marking and marketing authorization for these implants can be renewed.
ACLC only occurs with rough implants. The reason for this is unknown. The origin, progression, and treatment of the disease are unclear. Chronic prolonged inflammation in the tissue appears to trigger the disease. According to one theory, breast hardening, which is an infection caused by bacteria, may lead to ALCL in some cases. Preventing capsule formation could prevent ALCL. We have been using a surgical technique for the past 10 years that minimizes capsule formation. Therefore, the risk of ALCL should be very low if the theory holds true.
The symptom of ALCL is rapid and severe swelling of the breast, on average 7-8 years after breast implant surgery. Diagnosis requires draining fluid from the breast and microscopic examination. Obtaining a definitive diagnosis requires special staining and takes weeks. The disease can be treated. Usually, complete removal of the capsule around the affected breast and follow-up are sufficient.
Reason for concern? The disease is extremely rare, even if it were more common than initial reports suggested. There is no reason to remove or replace McGhan or Allergan implants. If your breasts become swollen a few years after surgery, you should consult a plastic surgeon who will take a cell sample from inside the breast. Mammography, MRI, or ultrasound examinations cannot provide a diagnosis.
We switched to smooth-surfaced Motiva implants over three years ago. There have been no reports of ALCL with Motiva implants, and overall, problems occur in less than 1% of surgeries. The shape of the breast is also pleasing, and the softness is in a class of its own.
Updated January 28, 2019
ANSM decides on CE marking for Natrelle implants on February 7-8, 2019
It is estimated that there are over 30 million women worldwide who have breast implants.
Updated February 15, 2019
Here is the ANSM decision regarding textured implants: “The committee’s recommendation to the ANSM said that Allergan BioCell implants should no longer be sold, and that caution should be applied to the use of all roughly textured implants. It said other textured implants remained appropriate for some patients and recommended against preventive explant surgery for patients who already have Allergan BioCell implants.”
Rough implants are therefore not recommended for replacement for medical reasons.
Updated April 5, 2019
The ANSM decision concerns certain models from Natrelle, Arion, Nagor, Polytech, Sebbin, and Eurosilicone (see ansm.sante.fr). Due to the rarity of ALCL, preventive removal is not recommended.
Updated May 3, 2019
The Food and Drug Administration (FDA, USA) continues to allow the use of Natrell, Mentor, and Sientra textured breast implants and tissue expanders, as there is insufficient scientific evidence to ban them. You can read the decision (May 2, 2019) here:
Updated on August 11, 2019
Allergan has withdrawn Biocell textured breast implants and tissue expanders from the market worldwide.
There are still no medical reasons for replacing old Biocell-coated implants.
