Breast implants have long been a cause of significant side effects for women who have received them. There has been a long history of breast implant lawsuits in response to hundreds of thousands of cases where there have been complications. In addition to the risk that the implants may rupture or leak, there are other health effects. Now, a certain type of breast implant has been associated with the risk of cancer in women. In Europe, this particular type of implant has been banned by the regulatory authorities. However, the Food and Drug Administration has decided to allow this product to remain on the market in the United States, perpetuating a possible risk of cancer in women who have received this implant.
Women Have Developed Cancer From Breast Implants
Roughly 300,000 women in the United States receive breast implants every year. The breast implants at issue are textured implants that are manufactured by Allergan. The implant is textured with a Velcro-like surface that attaches to the surrounding breast tissue. Many of the women who received this specific implant underwent mastectomies to prevent a high genetic risk of breast cancer. Instead of developing cancer from the genetic predisposition, many women claim that they have developed cancer due to the breast implant.
There have been roughly 660 reports of cancers that are allegedly connected to this type of breast implants. However, the FDA claims that some of these reports are duplicates and the true number is under 500. The specific type of cancer at issue is rare and is not directly related to the breast tissue in which the implant is placed. The cancer is called anaplastic large cell lymphoma. This type of cancer is found in the surrounding scar tissue and the fluid that is found near the implant. This cancer can affect the blood.
Cancer Was Linked to Breast Implants Since 2011
The FDA itself identified this link back in 2011. At the time, the agency had stated that it wanted to gather more information because there were very few reports of cancer in connection with breast implants. However, the number of reports began to steadily increase, necessitating further scrutiny on the part of the FDA. Since the initial reports, there have been studies that have endeavored to document the risks of this type of cancer after receiving implants. These studies have attempted to quantify the risk of cancer associated with this implant. The numbers range from 1 in approximately 3,000 to 30,000 women who have received this implant.
In France, regulators have taken steps to ban textured breast implants. It is important to note that French regulators did not explicitly state that textured breast implants are a cause of this rare type of cancer. However, the measure was taken as a precaution in light of mounting reports of a possible connection between the implant and cancer. In France, there have been 59 documented cases of cancer since 2011 which led to a ban on textured breast implants. At the time that France announced the ban, Allergan had already stopped selling this product in Europe because the certification had expired. France is not the only country to announce its intention to halt these sales as Canada and the Netherlands have announced similar plans.
FDA Permits Sales of Cancer-Linked Breast Implants
In the U.S., the FDA had asked for more information from providers and from the general public in February 2019. After that, the FDA held a public advisory committee meeting in March 2019. The meeting was held with the intent of giving the agency advice on a forthcoming decision about breast implants.
On May 6, 2019, the FDA announced its decision to continue to permit sales of the implant. The FDA stated that it did not have definitive evidence of a connection between breast implants and cancer. However, the FDA did state that it was aware of other conditions that may be caused by these breast implants and that women should be aware of these risks.
Proper Warnings Will Be Given to Women
In response to the information that it learned at the hearing, the FDA did announce several new measures. Specifically, the FDA vowed to disclose risks to women before receiving the implants. This would include the risk of anaplastic large cell lymphoma. The FDA has promised to disseminate this information to health care providers as well. In the meantime, the FDA will continue to update the public on the adverse event reports that it receives.
In order to ensure that all reported risks are known to the general public, the FDA has ended alternative summary reporting. The FDA had previously allowed adverse events to be hidden from the general public through this means of reporting. Recently, the FDA announced its intention to put a stop to this means of reporting. In the interim, the FDA halted it with regards to anaplastic large cell lymphoma reports connected to textured breast implants.
While the FDA did not ban sales of this implant, it did announce that it would consider a box label warning of potential risks. This is the highest level of warning that the FDA requires and is reserved for the highest risk products. This would include a checklist of the potential side effects of these implants. The FDA will continue to monitor the situation based on incoming adverse event reports.
Contact our Breast Implant Lawyers
Those who have received these implants and have been diagnosed with breast cancer may have questions about their legal options. The lawyers at KBA Attorneys can answer these questions. Breast implants are considered to be medical devices, and KBA Attorneys have years of combined experience in dealing with defective medical device lawsuits. We have assisted clients in filing and litigating numerous product liability cases in which those who have been injured by defective products have successfully sought compensation from manufacturers of the products. Contact KBA Attorneys to schedule a free consultation regarding textured breast implants.
- CBS News. “Breast implants tied to rare cancer to remain on U.S. market”, CBS News, https://www.cbsnews.com/news/breast-implants-tied-to-rare-cancer-to-remain-on-us-market/. Accessed May 9, 2019.