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Researchers from Penn State warn that recent increases in the number of breast augmentation procedures, particularly involving textured implants, will likely be accompanied by an increase in breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer that has been linked to the devices.
In a review published in the medical journal JAMA Surgery this month, researchers indicate that there has been a growing trend of women receiving breast implants, and cancer linked to certain types of implants is also likely to increase due to a number of factors; one of which being that no health agencies seem interested in taking action to restrict the sale or recall textured breast implants.
The review points toward strong evidence that breast implant cancer is linked to textured devices specifically. It also indicates that not all doctors or patients are aware of BIA-ALCL or the risks associated with treating the cancer. That will have to change if regulatory agencies do not address the problem and manufacturers keep making textured breast implants.
“We’re seeing that this cancer is likely very underreported, and as more information on this type of cancer comes to light, the number of cases is likely to increase in the coming years,” said Dino Ravnic, assistant professor of surgery, Penn State College of Medicine, who worked on the review. “We’re still exploring the exact causes, but according to current knowledge, this cancer only really started to appear after textured implants came on the market in the 1990s.”
Earlier this year, the FDA issued warnings about breast implant lymphoma rates, indicating that the agency was aware of at least 359 medical device reports worldwide involving women diagnosed with the rare form of non-Hodgkins lymphoma, including at least nine deaths.
Researchers reviewed 95 cases of breast implant cancer reported in literature, looking at 115 different research articles. In particular, they looked for age, time to onset, implant type, initial symptoms, treatment and survival.
According to the findings, almost all cases of BIA-ALCL have been linked to a textured implant. Most data appears to suggest that the cancer is caused by chronic inflammation from indolent infections, which cause T cells that are anaplastic lymphoma kinase (ALK) negative and CD30 positive to become malignant.
The study suggests that the mean time between breast implants and cancer is about 10 years. Most patients present as an isolated, late-onset seroma. However, for some, the first sign of a problem is an isolated new breast mass.
“To our knowledge, no cases have been documented from the pre–textured implant era, which suggests a causal relationship with textured implants,” the researchers determined. “All implant manufacturers have had cases of ALCL associated with their implants.”
Cases of Breast Implant ALCL Likely To Increase
The findings come just a couple weeks after the early results from a new breast implant ALCL registry were announced, indicating that there have been 148 distinct cases of BIA-ALCL in the U.S.
In June, another study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Researchers in the most recent JAMA Surgery review say that the number of cases is likely to increase.
“In recent years, there has been a significant increase in the use of anatomic implants, which are all textured, to offer the patient a ‘tailor-made solution’ with a more natural projection. However, recent evidence showed no aesthetic superiority of anatomic implants over round implants, and even plastic surgeons could not tell which type that patients had,” they wrote. “Currently, despite recognized linkage of certain implant types to ALCL, no known restrictive action has been taken by any regulatory agency worldwide. This places health care professionals as the key participants in recommending which type of implant should be used.”
As researchers continue to evaluate the specific cause of the breast implant lymphoma problems, many women are raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers are reviewing potential textured breast implant lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL), which develops in the tissue surrounding the breast.