FDA agrees to discuss BAN on certain breast implants

<pre><pre>FDA agrees to discuss BAN on certain breast implants

After years of campaigning, US health regulators UU They agreed to hold a public meeting of medical advisors in 2019 to analyze the safety and dangers of silicone breast implants.

The decision comes hours before the launch of a large study that suggests that rare health problems may be more common with silicone gel implants.

The Food and Drug Administration said it would hold the meeting even when its officials and several independent experts questioned the new study by the MD Anderson Cancer Center at the University of Texas.

The study involves nearly 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. UU After a gap of 14 years due to security concerns.

While the study leaders acknowledge that they have great limitations and can not prove that the implants cause any of these problems, they say they believe it is clear evidence of the risks.

"We fully support this study and believe it is our best information 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 obtain, he said.

The Annals of Surgery magazine plans to publish the report on Saturday. The study leaders have no current links to implant manufacturers, although Clemens consulted for one in the past.


Each year in the United States, about 400,000 women are implanted and most choose silicone over saline; Surgeons say that it can give a more natural look. Three quarters are for women who want bigger breasts; the rest is for reconstruction after cancer surgery.

& # 39; Breast implants are not devices for life & # 39; and up to 20 percent of women who obtain them for expansion must be removed within 8 to 10 years, warns the FDA website.

Complications can include infections, wrinkles, scars, pain, swelling and rupture of implants. Implant users may also have a very small but greater risk of a rare lymphoma, a type of cancer, according to the FDA.

But the agency decided there was not enough evidence to link silicone implants with other problems such as the immune system and connective tissue disorders, so it approved devices from two manufacturers, Allergan and Mentor Corp., in 2006. The FDA demanded that companies carry out more studies. about how women fared, and Texas researchers used these reports in an FDA database for analysis.


Compared to women without implants, those with silicone implants seemed to have higher rates of an immune system disorder called Sjogren's syndrome, a connective tissue disorder called scleroderma and skin cancer melanoma, although the cases of these were poor common, the researchers reported. But the rates of other problems such as fibromyalgia were lower among implant users. Reproductive problems, such as birth defects and stillbirths, were mixed and inconsistent.

In addition, a higher rate of rheumatoid arthritis was associated with one brand but with a lower rate with another. The difference lies in what the critics called a fundamental flaw in the data used for the analysis: an implant manufacturer required a diagnostic certificate from a doctor and not just a patient who reported a problem to include it in the database ; the other does not.

Another weakness of the study is that more than half of the women abandoned contact within two years of their operations.

Because of these and other deficiencies, we "respectfully disagree" with the conclusions of the investigators and urge that they be viewed with caution, Dr. Binita Ashar, of the FDA's Center for Devices and Radiological Health, said in a statement.


"This study is complicated" 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 president-elect of the Plastic Surgery Foundation, which supports the investigation and defense of the American Society of Plastic Surgeons.

The group obtains industry grants for some of their jobs, and Pusic obtains 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 of Aesthetic Plastic Surgery, said the inconsistency in some of the results is a bit difficult to explain, since the devices are chemically similar.

But the study is a worthy effort, he said.

"We have to constantly re-evaluate the data and make sure everything is safe," Thorne said. "The best evidence we have now indicates that there is no greater likelihood of these systemic diseases."