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Breast implants, considered medical devices by the U.S. Food and Drug Administration, are used in one of the most requested cosmetic surgical procedures in the country. In reconstruction surgeries, implants can rebuild breast tissue after a mastectomy, which may have been part of a woman’s breast cancer treatment. But what happens when breast implants actually cause cancer?
The FDA issued a statement on March 21, 2017, regarding breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), in which it concurs with the World Health Organization that BIA-ALCL is a rare T-cell lymphoma that can develop following breast implants. Data suggests that BIA-ALCL occurs more frequently with implants that have textured surfaces rather than smooth ones.
As of January 5, 2020, the FDA has received a total of 733 medical device reports (MDRs) of BIA-ALCL, including 33 deaths. More than 524 reports include information on the implant surface, with 496 reported to be textured implants and 28 reported to be smooth implants. Additionally, 447 reported implants were filled with silicone gel while 248 were filled with saline.
History of Breast Implants’ Link to Cancer
The FDA first identified an association between breast implants and lymphoma in 2011. At that time, the number of known cases of ALCL was limited, so it wasn’t possible to determine any factors that increased the risk.
In the past few years, the FDA has continued to review MDRs and current medical literature, as well as data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry). In 2016, there were several advances to defining the disease, including the designation from the World Health Organization. Additionally, professional organizations such as the Plastic Surgery Foundation and the National Comprehensive Cancer Network published information to help physicians understand the disease, its symptoms, and its treatment.
Like the U.S., the Australian Therapeutic Goods Administration issued a report in 2020 about cases and deaths from BIA-ALCL. None of the cases involved smooth breast implants. The regulatory body estimated the risk of developing BIA-ALCL to be between 1-in-1,000 and 1-in-10,000 women with breast implants.
In France, the National Agency for Medicines and Health Products Safety has asked manufacturers of textured breast implants to perform biocompatibility testing and report their findings within a year, so it can better be determined how living tissues react to textured implants.
U.S. Statistics on BIA-ALCL
In the U.S., two types of breast implants are approved for sale: saline-filled and silicone gel-filled. While both types have a silicone outer shell, they vary in size, shell thickness, shell surface texture, and shape.
Data on the latest MDRs in the U.S. related to BIA-ALCL includes the following:
- The median age of women with BIA-ALCL is 53.
- The median time from implant to BIA-ALCL diagnosis is 8 years.
- Textured implants accounted for 68% of cases; 28% did not specify implant surface.
- Silicone was reported as the implant fill for 61% of cases; 34% were saline; 5% were unspecified.
- 67% of women did not specify the reason for implant or it was something other than aesthetic or reconstruction; aesthetic reasons were reported in 16% of cases, while reconstruction was the reason behind 17% of these implants.
MDRs may be inaccurate, unverified, or underreported, among other issues, so the FDA doesn’t just rely on this passive surveillance system. The FDA’s Center for Devices and Radiological Health also looks to the Medical Product Safety Network (MedSun), post-approval studies, postmarket surveillance studies done by a manufacturer per FDA order, as well as FDA discretionary studies.
Diagnosis and Treatment of BIA-ALCL
Most recent studies suggest that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. To treat BIA-ALCL, the implant and the capsule surrounding the implant are removed. Some cases require chemotherapy and radiation.
However, BIA-ALCL generally has only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
If you have breast implants now, the FDA says there’s no need to change your routine medical care and follow-up. You should, however, make sure to follow your doctor’s instructions on monitoring your implants. If you notice any changes, contact your health care provider immediately. Routine mammography screenings also are important, while periodic magnetic resonance imaging (MRI) should be done if you have silicone gel-filled implants to detect ruptures as recommended by your health care provider. The first MRI should occur three years after implant surgery, and every two years thereafter.
If you don’t have breast implants but are considering surgery, educate yourself and talk to your doctor about the benefits and risks of textured-surfaced versus smooth-surfaced implants. It’s important to know before going into surgery that breast implants are not lifetime devices, and the longer a woman has them, the more likely she is to develop complications that may require additional surgery, such as ruptures or scar tissue squeezing the implant.
All confirmed cases of ALCL in women with breast implants should be reported through the FDA’s MedWatch Program.
Contact an Experienced Attorney if You’ve Been Injured
If you’ve done your research and have been injured by an implant, our experienced defective products attorneys may be able to help you get the compensation you deserve. Each approved breast implant sold in the U.S. has FDA Summary of Safety and Effectiveness Data, which provides risks, warnings, and studies associated with the FDA approval of the device. You’ll want to look into the frequency of complications, such as those that lead to further surgeries.
Similarly, you should have a good doctor. Breast augmentation and reconstruction are life-changing surgeries. While surgeons must evaluate the shape, size, surface texture, and placement of the implant and the incision site for each woman, sometimes they can make mistakes. Our experienced medical malpractice attorneys can review your case for potential damages at no cost.
If you live in Ohio, Indiana, or Kentucky, contact us today for a free, no-obligation consultation.