American health authorities opted to permit a kind of breast implant to stay on the market recently. The objection from many in the medical field is that this particular implant has been linked to an unusual type of cancer. The decision makers argued that the risks posed by this implant are not great enough to deserve a total national ban.
Yet despite this surprising decision, the Food and Drug Administration has declared that it is pondering stark warnings about particular implants. They may also mandate more stringent reporting of such problems by the manufacturers as well. This is the most recent announcement from a government agency on a fight that has been ongoing for decades now to mitigate the risks of breast implants and potentially dangerous complications.
France Bans Allergan 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.
Over the last several years, international regulators alongside the FDA have wrestled with the issue of this rare cancer link that has only recently been confirmed.
FDA regulators responded to queries about the landmark decision. They stated that they may not yet have conclusive proof that these implants lead to other chronic ailments, yet all women who consider implants should keep in mind the possibilities of such health risks. The agency added that it is contemplating including a new boxed warning on the product, the most serious kind it currently mandates. This would be a bold warning (in checklist form) of the potential harms that can befall women who do have them implanted in their bodies.
French authorities have recently ordered a breast implant ban on any associated with a type of lymphoma. This includes those implants the manufacturer Allergan is selling. Director for Medical Devices Jeffrey Shuren at the FDA said they were not yet prepared to pursue that additional major step. He argued that the analysis of all data and information available did not reach the level needed for banning the device.
Anaplastic Large Cell Lymphoma – A Rare Form of Breast Cancer
There have been roughly 660 reports of cancers that are allegedly connected to breast implants with a velcro-like texture. 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. Practically every confirmed case deals with a kind of textured implant that was originally designed with the purpose of stopping slippage as well as reducing scar tissue development.
Dr. Shuren reaffirmed that this particular breast implant device makes up under ten percent of the American market, mostly comprised of smoothed types of implants. He admitted that cases of cancer with smooth implants have appeared. This raises a number of questions about how many different factors may have combined to cause the disease.
President Diana Zuckerman of the National Center for Health Research has continuously studied the safety of breast implants over the years. The not-for-profit conducts its own research studies and evaluates the studies produced by other respected researchers. She argued that a ban would not be needed in order to phase out the textured implants. She said that this is because many doctors will simply avoid using them, and a number of informed patients will also state emphatically that they are not interested in having these kinds.
Such breast augmentation remains the most sought out type of cosmetic surgery in the United States today. Every year, around 300,000 individual women elect to have their breasts enlarged. Another 100,000 women have implants put in following cancer surgery to allow for breast reconstruction to be done.
New FDA Launched Issues Reporting System Will Help Promote Transparency
The FDA will continue to encourage greater public transparency. They will no longer allow the makers of breast implants to get away with only summarizing regular complications and injuries in bulk reports. The makers currently must report all significant malfunctions, injuries, and deaths that relate to these implantable devices. With the old reporting program that the FDA is using, these manufacturers are able to file simple quarterly updates that gloss over literally thousands of issues. The majority of these cases do not get included in the public database as a result.
The FDA has received criticism in the past for allowing this practice, and they have promised they will now phase it out. Critics argue that it obscures the real quantities of serious incidents that the regulators routinely get reports on. Reports received by the FDA are currently comprised of submissions from many groups, including lawyers, patients, doctors, and companies. Many of them frequently contain unverified and incomplete information and often duplicate complaints.
Just before a March meeting, officials at the FDA announced for the first time that they had received in excess of 350,000 individual reports on breast implants in the years over the past decade. According to former FDA staff member Madris Tomes, this expectedly high number represented around seven times more reports than those the public could view in the searchable database. Tomes feels that with a pattern exceeding 300,000 nonserious injuries and malfunctions, this important information should be in the public domain so that they can decide for themselves if it is significant.
Contact our Breast Implant Lawyers
If you have been diagnosed with anaplastic large cell lymphoma and have received breast implants, you may be eligible for a breast implant lawsuit. Breast implants are considered to be medical devices, and attorneys at The Eichholz Law Firm have years of combined experience in dealing with defective medical device lawsuits. We have assisted many plaintiffs in filing and litigating numerous defective medical device cases and have successfully sought compensation from manufacturers of the products. Contact The Eichholz Law Firm to schedule a free consultation.
- 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.