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US health regulators say they will hold a public meeting of medical advisers next year to discuss new scientific data on breast implant safety, including an independent analysis released on Saturday that suggests that some rare health problems could be more common with silicone gel implants.
The Food and Drug Administration said it would hold the meeting even as its officials and several independent experts were challenging the new job. The leaders of the study admit that they have great limitations and can not prove that these implants are causing these problems.
It is about 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed to return to the US market after 14 years of absence for security reasons.
"We fully support this study and believe it is our best data to date," said lead researcher Dr. Mark Clemens, a plastic surgeon at the MD Anderson Cancer Center at the University of Texas. Women need as much information as possible to make an informed decision about whether and what type of implant to get, he said.
The journal Annals of Surgery plans to publish the report Saturday. The investigators have no connection with the implant manufacturers, although Clemens has already consulted it before.
A popular choice
Each year in the United States, approximately 400,000 women get an implant and most choose silicone rather than physiological saline; surgeons say it can give a more natural look. Three-quarters are for women who want bigger breasts; the others are intended for reconstruction after cancer surgery.
"Breast implants are not lifelong devices" and up to 20% of women who obtain them for enlargement must have them removed within 8 to 10 years, warns the FDA website.
Complications can include infections, wrinkles, scars, pain, swelling, and implant rupture. Implant users may also have a very low, but increased, risk of rare lymphoma, a type of cancer, the FDA said.
But the agency decided that there was not enough evidence to link silicone implants to other problems such as the immune system and connective tissue disorders. It therefore approved the devices of two manufacturers – Allergan and Mentor Corp. on how women have been successful, and Texas researchers have used these reports in an FDA database for their analysis.
What they found
Compared to women without implants, silicone implants appeared to have a higher rate of immune system disorders called Sjogren's syndrome, a connective tissue disorder called scleroderma and melanoma of skin cancer, although these cases are rare. But rates of other problems such as fibromyalgia were lower among implant users. Reproductive problems such as congenital malformations and stillbirths were mixed and inconsistent.
In addition, a higher rate of rheumatoid arthritis was linked to one brand but at a lower rate for another. The difference is what critics have called a fundamental flaw in the data used for the analysis: an implant manufacturer required evidence of diagnosis by a physician rather than a simple patient reporting a problem to include it in the database; the other not.
Another weakness of the study is that more than half of the women were disconnected in the two years following their operations.
Because of these and other shortcomings, "we do not agree with the researchers' findings and urge that they be viewed with caution," said Dr. Binita Ashar of the Center for Applied Radiology and Health from the FDA.
What others say
"This study is messy" and has the potential to create more anxiety than insight, said Dr. Andrea Pusic, head of plastic surgery at Brigham and Women's Hospital in Boston and elected president of Plastic Surgery Foundation. American Society of Plastic Surgeons.
The group receives industry subsidies for some of its work, and Pusic receives royalties from a questionnaire used in many studies, including this one.
Dr. Charles Thorne, president of plastic surgery at Lenox Hill Hospital in New York and president-elect of the American Society for Aesthetic Plastic Surgery, said the inconsistency in some of the results "is a bit difficult to explain."
But the study is a commendable effort, he said.
"We need to constantly reassess the data and make sure things are safe," Thorne said. "The best evidence we have now indicates that there is no increased likelihood of these systemic diseases."
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Marilynn Marchione can be followed at @MMarchioneAP.
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The Associated Press Department of Health and Science is supported by the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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