Breast implants have become very popular with breast augmentations in the United States from 2000 to 2016 increasing 37 percent, and reconstructions after mastectomy rising 39 percent. Nearly 400,000 women in the U.S. get breast implants annually: 300,000 for cosmetic reasons and approximately 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. An estimated 1.4 million women worldwide got implants in 2015, reports the New York Times.
The U.S. Food and Drug Administration (FDA) notes that over the last six years, 359 reports were received of possible breast implant-associated cancer, including nine deaths, ABC Eyewitness News reports.
Reconstructive Surgery with Shocking Outcome
A Missouri woman had a double mastectomy after learning she had breast cancer, but in 2013, six years after her first diagnosis, she was struck with cancer again. This time, it was not breast cancer, but a rare malignancy of the immune system caused by the implants used to reconstruct her chest.
The woman had diligently visited her oncologist every three months, only to find that the very thing she had put in her body to help her recover emotionally, allegedly gave her cancer called “breast implant-associated anaplastic large-cell lymphoma. This rare cancer has affected a small proportion of the more than 10 million globally implanted women.
National law firm Parker Waichman LLP has extensive experience and success representing clients in personal injury litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential breast implant lawsuit.
Textured vs. Smooth Implants
Almost all of the cases have been associated with implants that were not a smooth covering, but with a textured or slightly roughened surface. Texturing may be the cause of inflammation that may lead to cancer. The vast majority of implants in the U.S. are smooth. The lymphoma is often curable, if detected early, according to the Times.
Only about 30 percent of plastic surgeons, as late as 2015, were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.
An alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines in 2016. Medical experts agree that the vital first step is to remove the implant and the entire capsule of tissue surrounding it. The disease is otherwise, likely to recur with an even worse prognosis, the Times reports.
Most of the cancers have developed from two to 28 years following implant surgery with a median of eight. The majority occurred with textured implants. Although most implants in the U.S. are smooth, texturing may be preferable, because tissue can grow into the rough surface and help to anchor the implant. Allergan and Mentor are the main manufacturers.
It is estimated by researchers that in Europe and the U.S., one in 30,000 women with textured implants will develop this kind of cancer. However, in Australia, the estimate is higher: one in 10,000 to one in 1,000. There is no answer to date of why there is such a discrepancy, reports the Times.
Speculation of Potential Causes
Whether silicone or saline is inside the implant, seems to make no difference in case numbers for the two kinds of substances. Also, the reason for the implants, whether cosmetic or reconstructive, does not appear to be a deciding factor either, reports the Times.
The cause of the disease is at this point, not known. One theory is that bacteria may stick to textured implants and form a coating called a biofilm that disrupts the immune system and may cause persistent inflammation, which may eventually develop into lymphoma. Other types of lymphoma stem from some chronic infections, so the theory is medically plausible. Professional groups for plastic surgeons advise using special techniques to prevent contamination in the operating room when implants are inserted.
“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. “The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, perhaps because they are more deeply textured and have a larger surface area for bacteria to stick to,” noted Dr. Clemens. Allergan uses a “lost-salt’ method that rolls an implant in salt to create texture and then washes the salt off. Other makers employ a sponge to imprint texturing onto the implant surface, the Times reports.
FDA Commentary
The FDA recommends that women with implants who are not experiencing any problems with their implants, should continue routine care, and do not need to have the implants removed. However, any symptoms such as breast pain, swelling, fluid buildup or lumps, should not be ignored.
Need Legal Help Regarding Implants?
The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
