The FDA has been taking in accounts since 2011.
The New York Times on May 14th tells the story of a woman who had breast reconstructive surgery after a double mastectomy, only to find six years later that a rare malignancy of the immune system was caused by the very implants she used to rebuild her chest.
Her disease is breast implant associated anaplastic large-cell lymphoma (ALCL) and the FDA has been tracking cases for six years.
This rare T-cell cancer is linked to textured breast implants because the cancer has been found around the implant site of breast implants with a textured surface.
Breast implants with a textured surface are used by plastic surgeons to reduce the rate of capsular contracture (hardening around the implant) and to stabilize the implant and reduce the risk of movement.
The U.S. Food and Drug Administration (FDA) has received 359 reports of possible cases of breast implant-involved ALCL but the exact number is unknown.
The Times reports the texturing is an abrasive that may cause inflammation, and that leads to cancer, on an average of eight years after implant, but cancers can develop from 2 to 28 years after the implant surgery.
In the early stages this cancer is often curable, if it has not spread. The first line of defense is removing the implant.
Another theory is that bacterial biofilm may cling to the texture of the implant that irritates the immune system with persistent inflammation. The silicone or saline component of the implant seems to make no difference in incidents of ALCL.
In transvaginal mesh biofilms have been found to grow around some polymeric materials protecting bacteria. They thrive in high humidity. See the Mesh News Desk story here.
Other types of lymphoma result from chronic infections.
Allergen, a maker of textured implants, is studying bacterial biofilms, inflammatory and immune response to implants, said an email spokesman to the NYT. Mentor, too, says it is monitoring reports about its implants and the link to lymphoma.
Symptoms of lymphoma include swelling and fluid buildup or lumps in the breast or armpit. The times reports that a diagnosis involves draining fluid from the breast to test it for CD30, an indicator of lymphoma.
In 2011, the FDA suspected a possible association between the development of ALCL and breast implants, but at that time, there were not enough cases to raise warnings.
By February, the FDA had identified 231 reports of cancer and ALCL and of those, 203 implants were reported to have textured surfaces while 28 were reported to be smooth implants.
The Times reports that as late as 2015, only about one in three plastic surgeons even discussed cancer with patients.
About 10 million women worldwide have received breast implants. Annually about 400,000 U.S. women receive breast implants with 300,000 for cosmetic enhancement and 100,000 for reconstruction after cancer.
Just Call Me Ray –website by Raylene Hollrah for women with ALCL
Facebook Group for Women with Breast Implant related cancer
New York Times, May 14, 2017, A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’
American Society of Plastic Surgeons/ American Society for Aesthetic Plastic Surgery on ALCL
Mesh News Desk, The Role of Bacterial Biofilms, June, 2015
Reports on the Essure birth control device are still being gathered by the FDA even though the device was taken off the market in late 2018. Essure was another questionable device marketed to women.
Dr. Amy Reed was scheduled to undergo a common surgery to remove fibroids. Little did her doctor know hidden cancer would be released by the medical device, which eventually killed her.
Dr. D. Veronikis is a St. Louis urogynecologist who is sought after internationally to remove polypropylene pelvic mesh and repair the damage it causes.