I’m sure anyone who has read a newspaper in the past few months is aware of the fears that are engulfing (of should I say filling) the French women who have received silicone implants. A company in France produced a popular (and apparently not too expensive) implant termed the Poly Implant Prothese (otherwise known as PIP). It was sold in 65 countries throughout the world over the last decade and used for breast augmentation or reconstruction in more than 300,000 women. The company that made the implants was shut down by the French government for fraud in 2010. It turns out that they had been using industrial grade silicone that was (obviously) not approved for medical use. The concern was (aside from the fact that no woman wants her breasts augmented with the same stuff they use in building or road construction) that these implants were far more likely to rupture…. apparently of the 30,000 French women who have had these implants, 1,000 experienced a rupture or leak. The French are advising those women who still have PIP implants to have them removed. Other countries are deciding what to suggest and many are simply suggesting that the women discuss “what to do” with their physician.

Why has this not been a problem here in the USA? This timely question was addressed in an article in the January 14th issue of Lancet titled “Silicone breast implants: lessons from the USA.”

The silicon-gel implants that are used in our country have been FDA approved after a long and arduous history. Currently the FDA assures us that they are safe. Their approval has allowed 150,000 American women to get silicone-gel implants for breast augmentation and 46,000 women to get them for breast reconstruction in the last year alone. In 2010 after 2 days of public testimony from silicon implant manufacturers, surgeons and scientists, the FDA concluded that American women can “consent with confidence to procedures involving silicon implants, which are considered safe but with acceptable risk of local complications (rupture, tissue hardening, pain, inflammation, and infection).” (Note the same complications occur with non-silicone, i.e. saline implants.) And just to be more precise the FDA published a 63 page report assuring the safety of silicon-gel implants.

There is quite a chronicle that preceded this. Silicon-gel implants were available in the US since the early 1960’s, but not until 1976 were they regulated by the FDA. In 1988, the FDA classified them as devices (duh) that needed their safety and efficacy to be proven in order to stay on the market. They gave the manufacturers 30 months to provide the necessary data. Apparently they could not. In 1991, it was deemed that the data did not fully assess the risks and in 1992 (this s a history lesson!) the FDA imposed a moratorium on silicon-gel implants. They were only to be used for reconstruction (after mastectomy for breast cancer or redoes of bad previous implants) and not electively for augmentation until their safety was proven. Then all hell broke loose (at least litigiously) and in 1995 the biggest US class action lawsuit took place, for $4.3 billion. Subsequently, publications in peer-reviewed journals and a 400-page report of the Institute of Medicine failed to link systemic disease with silicon breast implants. The ban was lifted in 2006 and since then 2 manufacturers; Mentor and Allergan have supplied the US market. They have promised to conduct ongoing post-approval studies and are following 40,00 women for 10 years,

So right now we feel (sorry about the use of this word) that our silicon-gel implants are safe. The authors conclude with the statement that “some critics argue that the FDA’s approval process is too slow and bureaucratic” But they add “but at what cost to safety?”

I agree with them. We should expect no less.

Here’s a great study for those of us who grew up in the 60’s, 760’s or, for that matte, up till present time. Smoking marijuana may not be as bad for our lungs as our parents, doctors (or we, to our kids) have said. A study published in the January 11, 2011 issue of JAMA titled “Association between Marijuana Exposure and Pulmonary Function over 20 Years” has come to the conclusion that…well before I give away the punch line let me set up the story (I mean the study).

There has been an ongoing survey in which, among other health issues, the pulmonary function of young adults has been followed for 20 years. It’s called The Coronary Artery Risk Development in Young Adults (CARDIA). The study was designed to measure risk factors for coronary disease (hence the title) in a total of 5115 men and women aged 18 through 30 over a period of 20 years in four U.S.A. communities (Oakland, Chicago, Minneapolis and Birmingham). The participants were felt to comprise a broad cross-section of typical tobacco and marijuana use patterns. They underwent a baseline examination with 6 follow-up exams over a total of 20 years. Pulmonary function testing was performed in years 0, 2, 5, 10 and 20. At each visit the use of tobacco (cigarettes smoked a day) and intensity of marijuana use (episodes in the last 30 days) was assessed. For the latter there was a questionnaire that asked about number of joints or pipe bowls smoked per episode. (No, they did not ask about brownies). This was then put in scientific terms or “joint years”. One joint a day or 365 joints a year was equal to 365 filled and smoked pipe bowls and this was termed a one-joint year. (Some would simply say it was a good year…I’m having a blast this!)

Here are the results: More than half of the participants (actually 54%) reported current marijuana smoking, tobacco smoking, or both on one or more exams. The tobacco smokers tended to have a lower education and income and to be slightly shorter and less active, whereas marijuana smokers tended to be taller and more active. (I’m not sure what to do with this fact.). To no one’s surprise, tobacco smoking (both current and lifetime) was associated with a decrease in pulmonary function. BUT, exposure to marijuana was NOT, and was actually associated with improved function! (This was measured with volume of forced expiration and something called forced vital capacity, which basically measures the ability of the lungs to expand, take in and let out air). But there was a caveat…. too much smoking of marijuana leveled this benefit or even reversed it.

The authors calculated that with 7 joint-years of lifetime exposure (which equals 1 joint a day for 7 days or 1 joint a week for 49 years) there was no evidence that marijuana adversely affected pulmonary function. Higher levels were not deemed equally safe, but the authors admitted that they had insufficient numbers of heavy users to confirm this.

Now why, one would ask, does smoking marijuana increase pulmonary function? (At least that was one of my questions.) Well, l some investigators have proposed that the deep breaths that are taken to get the marijuana smoke into the lungs (those reading this will probably know what I mean) can stretch the lungs and allow them to take in a larger volume of air. Also the musculature of the chest may improve…..a sort of “aspiratory training”.

The authors state at the end of the article: “Marijuana may have beneficial effects on pain control, appetite, mood and management of other chronic symptoms. Our findings suggest that occasional use of marijuana for these or other purposes (and I am assuming they mean recreation) may not be associated with adverse consequences on pulmonary function. It is more difficult to estimate the potential effects of regular heavy use….; however our findings do suggest an accelerated decline in pulmonary function with heavy use and a resulting need for caution and moderation when marijuana use is considered”

I wonder how many rewrites and consultations with lawyers were needed to come up with that last published sentence. In any case, occasional use doesn’t seem to hurt the lungs. I know a lot of people who will be reassured by this. I can actually tell them to “put this in their pipe and smoke it” (Purely a common expression and not meant to actually encourage marijuana use.) Amazing that smoking tobacco remains perfectly legal…

I know this sounds rather startling (but it does get your attention): Most of us have probably or will have a herpes simplex infection. There are two major herpes simplex viruses: herpes simplex 1 (HSV-1) and herpes simplex 2 (HSV-2). Although HSV-1 is the “one” that commonly causes the cold sores we get on our lips and mouth, especially when our immune guard is down, it can also cause genital disease. Herpes 2 is the more “classic” cause of genital herpes. (For more complete information on herpes see my article “Shedding the Herpes Virus: Even when you don’t know you have it” archived on my website judithreichman.net.)

Many of us have had our first bout of HSV-1 in childhood (and developed cold sores), but epidemiologists are now finding that more and more HSV-1 infections occur later in life, causing genital disease in young adults. The type of herpes that is present “up there”, or “down there” can be differentiated through a blood test for specific type 1 or type 2 antibodies. (The test is aptly termed Herpes Select.) However, most HSV infections occur without symptoms and only 10 to 20% of persons with antibodies to HSV-2 have recurrent disease. That’s why HSV is so easily spread, the virus can be shed without a lesion, is highly contagious and voila, sexual contact allows it to pass to and infect a partner.

As usual I spent part of my weekend perusing medical journals. The most interesting articles (for me) are often found in general medical journals, and sure enough there was one that appeared in the January 5th JAMA titled “Efficacy Results of a Trial of Herpes Simplex Vaccine”

There was a time before we became so concerned about the spread of HIV and HPV, when patient and doctor concerns were focused on herpes. The question commonly posed to gynecologists was “if we can put a man on the moon, why can’t we develop a herpes vaccine?” And we, the ObGyn’s would sadly bow our heads and admit research failure. Well the researchers are still working on developing that vaccine… The study reported in this article was supported by the National Institute of Allergy and Infectious Diseases and the pharmaceutical company GlaxoSmithKline. (Guess why the latter corporation is interested.)

The study of the efficacy of the herpes vaccine that they had tried to develop was appropriately performed. It was randomized, double-blinded and included 8323 women ages 18 to 30 that were negative for antibodies for HSV-1 and HSV-2. These women were divided into 2 groups and either received the investigational herpes vaccine at months 0, 1 and 6 or a control vaccine (which was an inactivated hepatitis A vaccine) on those 3 occasions. The women were then followed for development of HSV-1 or HSV-2 from one month after the second dose through month 20.

Although the study doesn’t seem that huge, it was…it was carried out at 50 clinical sites in the United States and Canada: 31,770 women were screened for antibodies to HSV-1 and HSV-2 and 12,468 were negative. From the latter group, 8323 women met eligibility criteria (I guess they agreed to take the three injections and could be appropriately followed) and were then enrolled.

The researchers found that, overall; the vaccine was 55% effective against HSV-1 infection but was not effective against HSV-2 infections even though it produced antibodies against HSV-2. They weren’t sure why. Rather than admit defeat (at least a type 2 defeat) the authors proposed the following: “Among the control subjects in the present study, 60% of the cases of genital disease and two thirds of the infections were caused by HSV-!….HSV-1 now rivals HSV-2 as a cause of neonatal herpes disease….and although the development of a vaccine that provides protection against HSV-1 genital disease is a substantial step forward, additional progress is needed before a herpes vaccine is likely to be approved for general use.”

In other words, we still don’t have that vaccine against herpes…even though we have put a man on the moon.

I thought I would start the New Year with a somewhat positive article that came out in the journal published by the North American Menopause Society. The journals’ name is appropriately, “Menopause”. Its cover is bright red…  I am not sure if this is meant to make it stand out or if the color represents hot flashes! I read the journal while trying to catch up on relevant articles during the holidays…these and my recent copies of the New Yorker have kept me mentally occupied. (I know that reading medical literature sounds boring, but actually I like it!)

So here is what caught my eye, and take a deep breath before reading the title; “Hip fracture in postmenopausal women after cessation of hormone therapy: results from a prospective study in a large health management organization”.

This was a study of 80,955 postmenopausal women who were 60 years old or older and had filled hormone therapy (HT) prescriptions at least once between January 2002 and June 2002. They were then followed through December 2008. (It takes years to gather the statistics, so most large studies will have concluded a few years before all of the results are actually published.)  The data on whether the women used HT, for how long,  and whether any antiosteoporotic medication was used, as well as the occurrence of hip fractures were collected from an electronic medical record system. The women in the study population were followed through Kaiser Permanente Southern California, which included 11 Southern California medical centers. (Yes they are huge!)  Bone mineral density was assessed with a DEXA scan in 54,209 women at least once  during the study period.

The results demonstrated that  during the 6.5 years of follow-up   (and after accounting for age, race and other medications), the women who discontinued HT were at a 55% greater risk of hip fracture than the women who continued to use HT.  The use of hormone therapy helped prevent fracture as long as it was used. But, within 2 years of stopping HT, hip fracture increased and the risk of fracture rose incrementally the longer the women discontinued this therapy. Every year that the women stopped HT was associated with a lower BMD (The T score which compare BMD to a 30 year old decreased on average – 0.13 a year.)

The authors concluded that “the public health message to women and physicians is that discontinuation of HT is associated with increased hip fracture risk and lower BMD compared to women who continue to take HT.”

There are many reasons to consider hormone therapy at the onset of menopause. For most women it is prescribed to help them deal with severe hot flashes, night sweats, sleep problems, mood changes and for some a feeling of “walking around in a fog”. There are also reasons to consider stopping after several years…. these include risk of breast cancer as well as a potential decrease in cardiovascular benefits.  The pros and cons of continuing HT for decreased risk of bone fracture should now also be considered. Who said this was easy! But it’s a subject that reaches epidemic proportions as approximately 1 million women enter the menopause each year in the United States.

In the year to come I’ll try to keep you up-to-date on the most recent published articles and studies on this and many other topics.

Have a healthy 2012!

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