Silicone Breast Implants- What will the USA FDA do?

Aug 31, 2011 by

Ugh. Really? I cannot believe things have come all the way back around to the point where the USA FDA is being urged to instruct Johnson & Johnson to pull silicone gel breast implants from the market.

The FDA had a hearing today (31 August 2011) to review the follow up studies on silicone breast implants, there was NOT any bad news regarding the safety of the silicone breast implants…but…Mentor (now owned by J & J) only has reporting from 21% of the woman that have had silicone implants since 2006 and this is well below the target (92%).

Okay- quick background. Silicone gel breast implants were re-introduced in the USA in 2006- they were approved by the FDA. But, there was the requirement that Inamed (now part of Botox) and Mentor (J & J) follow 40,000 women that received silicone gel breast implants for 10 years. Sounds great- right?

Not really, near BS in my book. Is it safe, or not? If it is not safe, don’t approve it. If it is safe, great. But all a continual study of 40,000 women does is drive up costs for the implants and *possibly* (if there is  a major issue) provide some coverage your bare bottom/we told you so protection.

This study does not make the 40,000 women any safer. You don’t need a study of 40,000 women to make women safer in the future.

And, before my soap box is kicked out from under me, WHY DOESN’T THE FDA LOOK AT WORLDWIDE SILICONE GEL BREAST IMPLANT USAGE FOR LONG TERM DATA. Hello? FDA? News flash for you folk….the rest of the world uses silicone gel breast implants. Yep, shocking I know, but the USA is years behind as most countries didn’t prohibit silicone gel breast implants from the early 1990’s until 2006.

So, instead of a massive 40,000 person study to look at the long term effects of the silicone breast implants- why not ask England or Germany or Australia or any of the other leading breast implant surgery markets around the world to share some of their long term data? Data that would date back…hmmmm….like 20 years? Might be helpful, no? With the advancements in technology, technique, certifications and general care, implant surgery performed today should be much safer than what was performed 5 or 10 years ago; much of the data the FDA could look at from other countries could be considered “worst case”.

But, no. Let’s have an expensive study that will not help any of the women in the study and WILL NOT address the local complications (capsular contraction, malposition) that occur in up to 20% of the implants according to the FDA. Nice!

The *only* part the Furry Brazilian finds relevant is the discussion about the poor performance of the implants- not the safety: During the Tuesday meeting, patients complained of side effects such as rupturing or hardening of the device, and said the companies’ long-term studies could be biased against patients who have problems.

The Furry Brazilian (as always) remains shocked the FDA continues to say things like this “In June, the FDA said the risks of breast implants are well understood, after looking at the companies’ results as well as reports of negative events and scientific literature. It said women who get silicone implants are likely to need additional surgery within 10 years.”

Really, let’s talk about how to reduce the local complications and need for additional surgery and not the viability of silicone based on the levels of enrollees in a follow up study.

The press release:

Consumer groups: Stop sale of J&J breast implants

(Reuters) – Consumer advocates asked health regulators to take silicone breast implants made by Johnson & Johnson off the market because the company has not been able to provide enough long-term safety data.

The groups spoke on Tuesday at a two-day Food and Drug Administration advisory panel meeting to discuss follow-up safety studies for silicone implants that have already been approved for sale. The FDA said the issue of product removal was not under consideration during the meeting.

But groups including the National Organization for Women Foundation and the National Research Center for Women and Families pressed the case.

The FDA approved silicone gel-filled breast implants sold by Allergan and Johnson & Johnson’s Mentor unit in 2006, on condition both companies follow 40,000 women for 10 years to look at safety issues, as well as extend smaller pre-approval studies.

Allergan has collected preliminary two-year data for 60 percent of participants, while Mentor has collected three-year data for only 21 percent.

“It’s unacceptable that many patients Mentor and Allergan were supposed to track were lost,” said Jan Erickson, of the National Organization for Women Foundation.

“Mentor’s approval should be rescinded right away. And Allergan should be required to conduct further studies.”

There were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010, according to the American Society of Plastic Surgeons. That includes silicone and saline implants.

In June, the FDA said the risks of breast implants are well understood, after looking at the companies’ results as well as reports of negative events and scientific literature. It said women who get silicone implants are likely to need additional surgery within 10 years.

The agency had banned silicone implants for most U.S. women in 1992 after some said the devices leaked and made them chronically ill.

During the Tuesday meeting, patients complained of side effects such as rupturing or hardening of the device, and said the companies’ long-term studies could be biased against patients who have problems.

In addressing low response rates, company representatives said the studies had perhaps “over-reached” by trying to keep track of so many patients, and by requiring each to fill out a 27-page questionnaire each year.

Mentor also said it may have had particularly low response rates because the company made patients participate in the study as a condition of getting an implant, but later changed it to voluntary participation.

“In retrospect, it’s perhaps not surprising that if a patient or surgeon enrolls because they are required to, and then a patient is told because of voluntary consent they’re not … that might contribute to low follow-up rates,” said Dr. John Canady, medical director at Mentor, when asked if the company’s study had any design flaws.

“That’s something we would go back to change, but obviously can’t in this study.”

Jean Silver-Isenstadt, executive director of the National Physicians Alliance, said the FDA needed to show its commitment to enforcing post-approval studies.

“We believe that this agency has to walk the walk,” she told Reuters. “Its mission is to protect patients, and when it sets criteria for approval, that should be real.

“When the agency begins to look more like window-dressing (for companies), that will shake the faith of physicians and patients.”The advisory panel will make its final recommendations on post-approval studies on Wednesday.

Or view the press release here: Press Release from Reuters

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