Women who receive textured breast implants may have a higher risk of developing anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin’s lymphoma.
To date, the FDA has received 359 reports of breast implant-associated ALCL, including nine deaths.
FDA CONFIRMS ALCL RISK
In 2011, the FDA first issued a warning about the increased risk of ALCL in women with breast implants.
In March of 2017, the FDA updated that warning after receiving enough confirmed reports to determine a link between breast implants and the rare form of lymphoma. Using the World Health Organization’s designation, the FDA classified the disease as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
As of February 1, 2017, the FDA received 359 reports of ALCL caused by breast implants, including nine deaths. Injuries and deaths have also been reported worldwide, including Australia where 46 cases and three deaths have been confirmed.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large cell lymphoma compared to women who do not have breast implants,” the FDA warned.
TEXTURED IMPLANTS POSE THE GREATEST RISK
Women who receive textured breast implants are 67.6 times more likely to develop ALCL.
The material of the implants does not appear to make a difference in whether or not a patient will develop ALCL. Of the 312 cases where the material was reported, 186 were made of silicone gel, and 126 were saline-filled. The outer layer of all implants is made of silicone. This layer can either be textured or smooth.
Women who receive implants with textured outer layers appear to have a much higher risk for ALCL. Of the 231 reports that included information on the breast implant coating, 203 were textured and only 28 were smooth.
Researchers are still trying to determine why patients react differently to the textured outer layer. Doctors have noticed that tissue tends to grow inside the grooves of textured implants—unlike smooth implants which can move around much more easily—which may make a difference.
Overall, women who receive textured breast implants have a 67.6 times higher risk of developing ALCL than women who do not receive breast augmentation surgery.
According to the FDA, BIA-ALCL is typically found in the scar tissue surrounding breast implants. It’s believed that chronic inflammation around the implants may cause the disease.
The average time between breast augmentation surgery and an ALCL diagnosis is 10 years.
If you received breast augmentation surgery and notice the following symptoms around one or both breasts, it’s recommended you consult a doctor:
- Fluid buildup
- Hardening or developed mass
In most cases, removing the implant and surrounding tissue is enough to eliminate the cancer. In some cases though, patients may need chemotherapy and radiation after surgery.
BREAST IMPLANT MANUFACTURERS
There are only a handful of manufacturers that make breast implants today. ALCL diagnoses are currently not associated with one particular brand.
The FDA has approved implant models from the following manufacturers:
- Mentor Worldwide LLC (a subsidiary of Johnson & Johnson)
- Ideal Implant Incorporated
FDA ISSUES 14-YEAR BAN FOR SILICONE IMPLANTS
In 1988, the FDA listed silicone breast implants in the highest-risk category for medical devices.
This isn’t the first time dangerous side effects have been associated with breast augmentation.
In 1988, the FDA listed silicone breast implants in the highest-risk category for medical devices—Class III. According to an FDA study, 69% of women with silicone-gel implants experienced a rupture and required additional surgery.
Women filed lawsuits against manufacturers, alleging that the implants leaked and caused cancer and rheumatoid arthritis. Dow Corning Corp. was one of the leading manufacturers of breast implants at the time. 19,000 women filed lawsuits against the company, causing them to declare bankruptcy after paying a $3.2 billion settlement.
The FDA asked manufacturers to provide safety data on silicone implants. Failing to do so, the FDA issued a federal moratorium in 1992, banning silicone implants for cosmetic surgery. They stated that there was “inadequate information to demonstrate that breast implants were safe and effective.”
It wasn’t until 2006 that the FDA lifted the 14-year-ban. However, they still acknowledge the risks of silicone implants.
Dr. Daniel G. Schultz, former director of the FDA’s Center for Devices and Radiological Health, warned in an article for The New York Times, “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery.”
BREAST IMPLANT LAWSUIT ALLEGATIONS
Lawsuits against breast implant manufacturers make some combination of the following allegations:
- Defective and dangerous design
- Failure to warn patients and medical professionals of risks
- Causing patient harm
HOW A LAWSUIT CAN HELP
If you experienced medical device complications, you may be eligible for a lawsuit against the manufacturers.
A lawsuit can result in compensation for the following:
- Medical bills
- Loss of wages
- Pain and suffering
Contact our attorneys for a free, no-obligation legal review.