IT'S ALL ABOUT THE DOTTED LINE _ _ _ _ _ _

Coincidental?  Ironic??  Clueless but I will give a nod to my pals over at Breast Cancer Action for sending this into the twitterverse yesterday afternoon:

Why did the FDA approve a new silicone breast implant without good safety info? Via @nrc4wandf bit.ly/VQhH6x #breastcancer
— Breast Cancer Action (@BCAction) February 21, 2013

It's in keeping with my outrage over "lab rats" and "informed consent" and this was quite serendipitous indeed.  I get to punctuate my point.  Personally.  Up close and personal, personally.

The link in the tweet is to the National Research Center for Women and Families where the following statement written by Dr. Diana Zuckerman appeared:

Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc.

The FDA based its approval on data from 941 women, which is a very small sample. The FDA reports that the complications from these implants are similar to those for other breast implants: pain and hardness caused by scar tissue (capsular contracture), the need for additional operations to fix implant problems, the need to remove the breast implants because of problems, uneven appearance (asymmetry), and infection.  The studies also found cracks in the gel of some Natrelle 410 implants, which has not been found in other breast implants.

Unlike other breast implant approvals, the FDA did not hold a public Advisory Committee Meeting to discuss the data, nor did they make the study data public for these new breast implants.  What are they afraid of?  It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants.

The silicone gel in the Natrelle 410 implant contains more cross-linking compared to the silicone gel used in Allergan’s previously approved Natrelle implant. This increased cross-linking results in a silicone gel that’s firmer. Cross-linking refers to the bonds that link one silicone chain to another. Some physicians believe this will make the implant last longer, but there is no evidence to support that because these implants have only been studied for 7 years.

The FDA admits that Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market.

As a condition of approval for the Natrelle 410 breast implants, Allergan must:

▪    Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;

▪   Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications);

▪   Conduct five case-control studies to evaluate whether women with Natrelle 410 implants, or other silicone gel-filled breast implants, are more likely to develop rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;

▪   Evaluate women’s perceptions of the patient labeling; and

▪   Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.

Unfortunately, Allergan has not done a good job of doing post-market studies once their implants have been approved.  And, even if they do these studies, by the time these studies are done to find out what the risks are, hundreds of thousands of women could have these inadequately studied devices in their bodies, and could have been harmed by them.

Not sounding too good, is it?  If you care to see the FDA press release, it can be found here but Dr. Zuckerman did a terrific job of including all of the important information in the FDA announcement.

Why does any of this matter?  Obviously, there are risks associated with these particular implants and the long term evidence is not yet available.  Like Dr. Zuckerman, I'm a little bothered by the fact that they clearly indicate there are 3500 women walking around with these things yet they based their approval on the satisfaction of 941 women.  What about the other 2500 women?  Did they have problems?  Were they serious?  If it's standard procedure to hold a hearing, why was this rubber stamped behind closed doors?

Lots of questions and I would think we should all be entitled to the answers.  Wouldn't you agree?  It's possible I'd like the answers with a bit more urgency.  You see, I am a part of this study.  I may be one of the 941 women upon which the approval was based.  These particular implants have been in my body for almost six years.  I have no complaints and no issues.  I'm as happy as one can be to have foreign objects under the muscles on my chest.

Today, Magic 8 Ball says, "You will be in an MRI machine within the next two months."  My annual follow up with the plastic surgeon is in April.  I've been thinking about those 3D tattoos.  Mine are fading.  I think I should wait to make sure nothing is cracked.  My luck, I'll get the great tattoos and then wind up in an operating room having these things replaced.  IF that happens, however, I went into this will the full understanding of what I was doing.

Unlike the women in India, I have the 17 page consent form outlining every conceivable, imaginable, this could happen to one in every 2 million women obscure problem.  There was a long discussion before we got to page 17 where my signature appears.  I was informed.  I gave consent.  I KNEW the risks associated with my choice.

This is what "informed consent" forms look like (after they have been unstapled and fanned out):

Both the doctor and I signed this particular document, IN THE SAME ROOM at the same time, after everything was fully explained to me.














I was provided with the names of every possible person or agency with whom information about me could be shared:

I'm pretty sure it was over an hour before this signature was put on that INFORMED CONSENT  -------->













This was a 17 page document and it was crystal clear that I would be getting a copy.  Written in plain, easy to understand language, if I wanted to do something differently, I could go back and read, in detail without any missing information, exactly what I got myself into.  Or more accurately, what got (put) into me.

Somehow, I get the sense this is not even close to what happened with a over quarter of a million women in India who were part of the studies that still have me beyond infuriated.  Somehow, I don't think anyone took the time to review those forms with those women.  I doubt the full ramification of what the forms meant to those women was fully and properly explained when a large majority of the forms had this on that dotted line:

In the world of research, we should all be created equal.  Sadly, we have much work to do.