"How many patients do we need to prove there is a migration of silicone into the body?” Dr. Jan Tervaert asked the FDA panel charged with looking at the new concerns over the cancer risk from certain breast implants. That was the tone of the first day of testimony on this issue.
Last week the Food and Drug Administration issued warning letters for two breast implant manufacturers citing what the agency calls a failure to comply with safety testing requirements. Now the FDA is holding a meeting to take a closer look at cases in which breast implants have been linked to cancer. The meeting includes testimony from patients, doctors, and industry representatives.
Read MoreThe warning letters to Mentor Worldwide LLC in Irvine, California, and Sientra, Inc. in Santa Barbara, California claimed both companies failed to properly complete their “post-approval studies” — or studies on products that are already on the market — on the long term safety and risks of their silicone gel breast implants.
"Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we'll continue to hold manufacturers accountable when they fail to fulfill these obligations," said FDA Commissioner Scott Gottlieb, M.D.
After the FDA’s sent it’s letter to Mentor Worldwide LLC, the company said that it was disappointed with the FDA’s decision to issue a warning letter, even though the company has tried to address post-approval study requirements with the FDA. “A number of the details cited in the Warning Letter are incorrect and incomplete and we look forward to the opportunity to further discuss these discrepancies and next steps with the FDA,” the company said in statement, according to NBC News.
Sientra, Inc. replied that it would attempt to rectify the issue. “Sientra takes this matter seriously and will take all necessary steps to address the topic of the warning letter issued by the FDA.”
FDA Advisory on Implants
This news comes after the Food and Drug Administration issued a broad-based advisory about breast implants and cancer risk. In the advisory, the FDA said that it had received reports of 660 cases in which women who received breast implants subsequently developed a rare form of lymphoma.
The blood cancer that implants may cause, called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of non-Hodgkins lymphoma and is completely distinct from breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant and breast area.
The Food and Drug Administrationresponsible for regulating medications and medical deviceshas acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011. Now they've updated that information.
"After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases since 2010," the report said. "Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths," the report continued. "MDR" stands for Medical Device Reports, so there's been an increase in the number of reports the FDA has received about instances of the disease.
"We understand that the information presented shows an increase of 246 new MDRs since last year," said the FDA. "These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis."
There are also a couple issues with the numbers that have to do with reporting problems. "In addition, it is difficult to determine the total number of cases or estimate risk from the MDR reporting system due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants," the FDA warned.
Initial Risks With Allergan Implants
Previously, the issues the FDA highlighted were tied to one specific brand. At the end of 2018, Allergan, a leading global biopharmaceutical company, suspended its sales of textured breast implants and tissue expanders, and withdrew its supply from all European markets. "The withdrawal decision follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company's CE Mark for these products," Allergan announced at the time.
What do breast surgeons say about the safety of implants?
Dr. Darrick Antell, a private practice plastic surgeon in New York City, says that these instances are rare, and as a result, implants aren’t that risky. "Textured surface implants have rarely been noted to develop ALCL, at a rate of 1 in 30,000I would even recommend them to a family member," he says. "Multiple leading institutions from around the world have shown them to be safe."
Breast implant do not always lead to lymphoma, but it's a dangerous illness for those who do get it. "ALCL is rare, but for those who get ALCL from their breast implants, it is very frightening and potentially fatal," says Diana Zuckerman, PhD, President of the National Center for Health Research.
But, as Dr. Zuckerman urges, it's important to discuss the risk with your doctor before getting implants, because some women felt blindsided and uninformed about the disease possibility. "We know women who, when they developed ALCL, felt betrayed because their doctors hadn't warned them of the risks."
Breast implants also have the possibility of causing other health or physical issues. These issues have not been fully studied, but Zuckerman and the NCHR recently released a paper that discusses some of the possible side effects.
The risks that come with implants are real for all women, Dr. Zuckerman tells SurvivorNet, but these risks increase with a personal or family history of autoimmune or connective tissue symptoms or diseases. They can happen soon after getting implants or years later, and are especially likely when a silicone gel implant breaksmost likely after three years. Another issue is that leaking silicone can migrate into the lymph nodes, and, "from there, the silicone can get into the lungs, liver, or other organs." Broken saline implants, she continues, offer less risk when they leak, but can cause health issues from the silicone shell, other chemicals, as well as from bacteria, fungus and mold issues that develop over time.
Implants and Cancer Risk In The Past
This isn't the first instance of concern regarding breast implants and potential health risks. Throughout the 1980s and early 1990s, silicone manufacturer, Dow Corning was named in a number of class-action lawsuits claiming that their breast implants were the cause of a number of health issues.
In 1992, the FDA mandated that silicone implants be removed from the market, but in 2006, they came back onto the market with stricter regulations. Patients had to be tracked for at least 10 years after their surgeries. But because monitoring the implants and patients with them is not always thorough nor properly reported, it’s hard to know for sure what side effects implants are having in the long term.
The best idea, as always, is to discuss all the possible risks and benefits of implants with your doctor before any procedures, and be on alert for any symptoms that indicate a medical issue, suggests Dr. Zuckerman. "If a woman with implants starts to have any of the autoimmune symptoms that we've described in our report, she should consider having her implants removed."
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