FDA issued a recall last month of breast implants made by Allergan. The agency cited a higher risk of cancer among patients who had implants made by the pharmaceutical company.
FDA discovered that people with the BIOCELL textured breast implants had a higher risk of getting breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL. Symptoms of this cancer include pain and swelling around the breast implant area. (LAtimes.com)
FDA stated in a press release that once the evidence showed that the breast implant seemed to be related to direct patient harm, FDA took immediate action to alert the company about new evidence and the recall was initiated.
Allergan has stated in response that it would fully comply with the recall order and cease the sale of BIOCELL saline and silicone implants around the globe. But currently Allergan is facing dozens of lawsuits from consumers who claim the company was aware of the link between the breast implant and cancer as early as the early 1990s, but it continued to sell the products.
In 2018, several women filed personal injury lawsuits against Allergan in California and New Jersey.
Long History of Lawsuits Against Breast Implant Manufacturers
There is a history of litigation involving companies that make breast implants for a variety of personal injury to consumers. Courts have in the past awarded as much as $250,000 for people suffering from an illness or disease related to a breast implant.
In the 1980s and 90s, several US courts determined that drug companies were liable in class action lawsuits that amounted to billions of dollars in damages.
One of them was a 1998 ruling against Dow Corning for more than $3 billion. The court required Dow Corning to pay women for the cost of taking out the implants as well as litigation and personal injury against the company, which forced it to declare bankruptcy.
Also, in 2016, two women sued Mentor Worldwide, alleging they had developed health conditions related to the company’s silicone breast implants. Several consumers have filed breast implant bia-alcl lymphoma lawsuits against Allergan in the last month, as well.
FDA has been closely studying risks associated with textured breast implants for several years. In March, FDA had two days of hearings that featured testimony from women who said they had gotten cancer because of their breast implants. Women with the Allergan implants reported conditions such as chronic fatigue, hair loss, intestinal problems, and itching and rashes.
But FDA found that the data that exists does not show a strong enough connection between cancer and implants and did not issue a recall.
New Research Suggests Possible Cancer Link
However, recent research shows that out of 573 incidents of BIA-ALCL around the globe, 481 of the cancer sufferers had Allergan implants. Of the 13 cases of the cancer where the maker of the implants were known, 12 were from Allergan implants. FDA issued a ban last week after new data showed a higher risk level to consumers.
FDA stated the risk of getting BIA-ALCL was six times greater for patients who had the Allergan BIOCELL textured implants than it was for people who had textured implants from other breast implant manufacturers. Patients who had implants from cosmetic surgery and those who got them after mastectomies were at higher risk of this type of cancer.
The Allergan implants were taken off the market in Europe in 2018 and have been banned in Australia and Canada. FDA said they would continue to look at other types of macro-textured breast implants to determine if there is a health risk to consumers. In the United States, textured implants are also sold by Sientra and Johnson & Johnson.
What Is BIA-ALCL?
BIA-ALCL is a form of non-Hodgkins lymphoma cancer, which is a cancer affecting the immune system. It is not actually breast cancer. BIA-ALCL develops in scar tissue and fluid that is around the implant. Researchers have been unable to understand the connection between macro-textured implants and the cancer.
FDA did not tell patients with the Allergan BIOCELL implant to have them removed unless they show signs of cancer.
Doctors can diagnose BIA-ALCL with a physical examination, as well as assessing the fluid and tissue around the area of the implant. FDA said that any patient diagnosed with the cancer should talk to a surgeon to have the implant and scar tissue removed immediately. Some cancer cases could require chemotherapy and radiation.
Macro-textured breast implants are less than five percent of the implants sold in the United States, FDA reports. The recall includes the Allergan Natrelle Saline-Filled Breast Implants as well as the firm’s Tissue Expane and Plus Tissue Expander.
- Allergan Breast Implant Recall. (2019). Retrieved from https://www.latimes.com/business/story/2019-07-24/allergan-breast-implant-recall-cancer
- What You Should Know About the Allergan Breast Implant Recall. (2019). Retrieved from https://www.sieberplasticsurgery.com/articles/what-you-should-know-about-the-allergan-breast-implant-recall/