SALT LAKE CITY — Following complaints from thousands of women that their breast implants are causing a series of ailments ranging from debilitating pain to a rare form of cancer, the Food and Drug Administration is holding hearings Monday and Tuesday to give renewed attention to implant-related health complications.
For years, women who reported muscle pain, fatigue, cognitive difficulties, and other maladies after receiving breast implants haven’t been taken seriously, according to The New York Times.
Now, that’s beginning to change. On March 19, the Food and Drug Administration issued warning letters to two manufacturers of breast implants, Irvine-based Mentor Worldwide LLC and Santa Barbara-based Sientra, Inc., for failing to conduct comprehensive “post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.”
Because conducting the long-term studies was a condition of the Food and Drug Administration approving the implants, both manufacturers now risk having their products taken off the market.
The agency's warning comes on the heels of its March 15 statement outlining the potential risks of implanted medical devices, including the potential for patients to have an immune or inflammatory reaction when a device is implanted. The statement also outlined efforts to compile and synthesize data from multiple sources on medical device safety to allow it to respond to concerns more quickly and ensure patient safety as medical technology evolves.
This week's public hearings will involve testimony from plastic surgeons, researchers, manufacturers, and patients about implants and their potential risks, focusing on links between implants and a rare cancer as well as generalized "breast implant illness" symptoms. The findings will inform future FDA recommendations.
Let’s take a closer look at the complications that can arise from breast implants and what experts, manufacturers, and patients have to say about this medical device.
What complications and serious medical issues can arise from breast implants?
The complications that can arise from breast implants have the potential to affect the estimated 10 million women worldwide who have implants. According to the Times, around 400,000 American women get breast implants every year — 300,000 for cosmetic purposes and 100,000 for reconstruction after mastectomies to treat or prevent breast cancer. According to the American Society of Plastic Surgeons, breast augmentation was the most popular cosmetic surgical procedure of 2018.
Breast implants were recently confirmed to be linked to a rare form of cancer called anaplastic large cell lymphoma, which affects the immune system. According to the FDA, the cancer has been detected in 457 women who received breast implants, and although removing the implants usually gets rid of the cancer, some women have needed chemotherapy and, as of September 2018, nine have died.
Cases of anaplastic large cell lymphoma have largely occurred in women with breast implants that have a textured surface, which aims to reduce scarring and implant slippage. However, in the U.S. it is much more common for women to get implants with a smooth surface. In September, textured implants made by mega-manufacturer Allergan were taken off the European market because of their ties to the cancer.
In addition, many women have lodged complaints of “breast implant illness,” which, according to the Times, includes maladies that can “cause muscle pain, fatigue, weakness, cognitive difficulties and other debilitating symptoms. Some ailments fall into a category called connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases.”
How seriously have the long-term health effects of breast implants been studied?
There are two types of breast implants: silicone and saline implants, both of which have a silicone shell. According to The Washington Post, most American women choose silicone implants because they look more natural.
Silicone implants first hit the U.S. market in the 1960s, and following a slew of reports of ailments purportedly caused by the implants, they were banned in 1992, the Times reported.
Following the ban, several studies were conducted to determine whether there was a link between implants and connective tissue disease. While none of them conclusively proved a link between the two, several did suggest that there was a connection, the Times reported.
In 2006, silicone implants were allowed to re-enter the U.S. market on the condition that their manufacturers conduct extensive studies that would follow large numbers of women for seven to 10 years after receiving implants to determine if they had any deleterious effect on the women's health, according to the Times.
The warning letters released by the Food and Drug Administration last week reveal that Mentor Worldwide and Sientra have not been conducting those studies satisfactorily.
According to the letters, Mentor Worldwide did not enroll an adequate number of patients in the study and had poor follow-up rates with patients. In addition, their study had “significant data inconsistencies ... including poor patient accounting and missing race and ethnicity data.” Sientra also had poor follow-up rates with patients in their study and hasn’t taken adequate measures to address that, despite prior warnings, according to the letter.
Both manufacturers are required to respond to the Food and Drug Administration by next week with detailed plans of how they will address the agency’s concerns.
Is it safe for women to get breast implants?
Many experts in the field say it is safe for women to get breast implants, and add that many who do have implants are happy with them. At the same time, they caution that, just like with any medical procedure or with the use of any medical device, there are risks that need to be considered. According to data from the Food and Drug Administration, around 20 percent of women with implants elect to have them removed after eight to 10 years due to, or in order to avoid, complications.
Several recent studies that have more comprehensively examined the long-term health effects of breast implants "have found disproportionately high rates of some uncommon chronic diseases among women with implants," according to the Times.
However, the studies "show only associations and do not prove a cause-and-effect relationship."
One study published in January, which was led by plastic surgeons at M.D. Anderson Cancer Center in Houston and encompassed 99,993 women who had received silicone implants, found that they were six, seven, and eight times more likely than the rest of the population to have rheumatoid arthritis, a connective tissue disease called scleroderma, and an autoimmune disorder called Sjogren syndrome, the Times reported.Comment on this story
Another study published in December 2018 compared 24,651 women with silicone implants to 98,602 women without implants and found that the women with implants were 22 percent more likely to have an autoimmune or rheumatic disorder, the Times reported.
Although none of these studies have conclusively proved that there are causal links between breast implants and these disorders or afflictions, they have nonetheless raised concern among patients and in the medical community.
"Implants are not so innocent as presented," Dr. Howard Amital, a rheumatologist who was the senior author of the December study, told the Times. "There is a reason for concern. There is something we cannot ignore."