Women saying they were injured by breast implants required the Food and Drug Administration to take new steps to protect consumers, including providing more information on potential risks and equipment bans with the most serious complications, including cancer.
Tells stories of broken health, disturbed families, and lost careers, the women pushed an FDA advisory panel to recommend longer-term research, bans or restrictions to certain products and a combed information process so women have a clear understanding of risks and benefits at the units before choosing surgery.
"I was not warned" about the risk of implants, Jamee Cook, a lawyer and formerly ER paramedic, told the FDA's expert committee. Cook, who lives near Dallas, said that after years she had implants in 1998, she suffered for years from swollen lymph nodes, chronic fatigue, migraine and low-quality fever. She said she eventually had the devices removed, after which many, but not all, of her symptoms were relieved.
The FDA recently said it is looking at implants that have triggered anger and strife for decades. The Agency asked its Advisory Committee on General and Plastic Surgical Units for recommendations on a wide range of issues, and Cook's testimony was part of a two-day hearing that continues on Tuesday on the key issues.
Several plastic surgeons urged the panel to proceed cautiously and say that implants are generally safe and an important option for women who want breast augmentation or post-breast reconstruction. They said women's choices should not be limited. About 400,000 women a year receive implants, 75 percent for cosmetic reasons and the rest for reconstruction after breast cancer surgery.
Many of the dozens of patients who attended the FDA Headquarters meeting in Silver Spring, MD, Bar for Graphics indicate their concern over two types of diseases they say are associated with implants. Black and white ribbons symbolize what is now called "breast implant disease", a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue. Pink and green ribbons meant an unusual lymphoma that the health authorities around the world, including the FDA, link to some implants.
Anastasia Allmendinger, a 53-year-old resident of Newport News, Va., Said she got implants in 2010 and years later was diagnosed with the cancer, called anaplastic large cell lymphoma or ALCL. She underwent surgery to remove implants, chemotherapy, and stem cell transplantation, and it is doing well now, but says that producers should be held accountable for the diseases and women should be better informed. Experts say many patients can only be treated with surgery.
Many of the lawyers who spoke Monday called for a ban on textured implants – the kind of strongest associated with the cancer. There are some signs that the problem could be due to bacterial infections involving the implants, the researchers say.
The FDA has identified 457 cases of lymphoma and nine deaths in the United States. Six hundred cases and 17 deaths have been reported worldwide.
On the second major disease's concern – the one associated with autoimmune and connective tissue disease – the FDA and the patient community have long been in conflict.
Thousands of women have complained about autoimmune and connective tissue problems on social media, but the FDA has repeatedly said that "the weight of evidence" does not show implants causing "systemic" disease.
This statement was challenged last September when the researchers at the MD Anderson Cancer Center found that silicone implants were associated with higher levels of autoimmune diseases such as scleroderma and rheumatoid arthritis than those found in the general population. A leading author, Mark Clemens, said the study did not show cause and effect, but was a cause for concern.
The FDA immediately expressed skepticism and said the investigation was flawless. But Binita Ashar, the agency's director of surgical devices at the FDA Center for Devices and Radiological Health, also said the agency is stepping up its long-term monitoring of implants and using patient records to track complications from the devices.
This view was repeated in the Agency's announcement of the meeting, which began on Monday. The FDA said there is insufficient evidence to show a link between breast implants and rheumatologic or connective tissue disease diagnoses. "But it was added," there are many breast implant patients who call on social media to discuss a large number of symptoms they experience – symptoms that may or may not meet the diagnostic criteria to be categorized as a disease. "
Diana Zuckerman, president of the National Center for Health Research, said in an interview she did not understand" why the FDA is so consciously aware "of the scientific evidence that at least some women have developed autoimmune diseases due to their "We have always said that we do not know what the percentage is – just for women who are ill, to get them out, make them better," she said.
Zuckerman presented data Monday from a study by her The group conducted involved more than 400 women who had their implants removed because they had health problems, in most cases she said that women's health was improved, the study has not yet been published.
The FDA banned most implants in 1992 , but lifted this ban in 2005. The agency approved implants made by Allergan and Mentor in 2006, requiring them to conduct long-term impact studies on k Winner's Health
Recently, the FDA has strengthened its study of the devices. Last week, it sent warning letters to two major implant manufacturers, saying they had not carried out required safety studies on the devices in the long term and warning that the units could be ordered from the market if the investigations were not completed. The agency also recently said it would look into how materials used in a number of surgical implants – including those used in hip and knee replacements – could potentially affect health.
The Nation's Chief of Cancer appointed FDA Commissioner