FDA issues warning against breast cancer screening by thermogram

The US-FDA has issued a consumer health alert that thermogram breast cancer screening test is no substitute for mammography because of lack of scientific evidence in favor of thermogram.

This alert was issued in wake of reports received from many healthcare centers and patients that many providers are misleading patients into believing that thermogram can be a substitute for mammography.

Helen J. Barr, M.D., director of the Division of Mammography Quality Standards in the FDA’s Center for Devices and Radiological Health said, “Plenty of evidence shows that mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages. You should not rely solely on thermography for the screening or diagnosis of breast cancer.”

Those patients who are screened with thermogram may be falsely assured that they do not have cancer as it has high false negative results. Similarly, patients may receive a false diagnosis of breast cancer when in fact they do not have any lesion.

Thermography was only cleared by FDA as an adjunct tool, to be used with a primary screening method. Some women prefer to get the test done as it is painless and does not expose the patient to radiation.  

FDA also stressed that claims by websites that thermography detects cancers earlier than other screening methods does not have any scientific evidence.

FDA has further taken regulatory action against manufacturers of thermography devices and healthcare providers who are misleading patients to believe that thermography can replace mammography.

FDA has put the alert on consumer update page and it continues to monitor the situation.

FDA consumer alert 

Media Courtesy: FDA

Younger age at hysterectomy linked to increased risk of heart disease later in life

Ovarian conservation at hysterectomy does not reduce the risk of future cardiometabolic diseases reports the results of large prospective cohort study published in Menopause, the journal of The North American Menopause Society (NAMS).

This is one of the few studies that focuses on long term effect of hysterectomy with ovarian conservation. Earlier studies have documented strong evidence between increased incidence of cardiovascular diseases(CVD) and other chronic diseases after hysterectomy with bilateral oophorectomy.

The risk was especially increased if the hysterectomy was carried out before the age of 35.

Using Epidemiological project record, the researchers identified 2094 women who underwent hysterectomy with ovarian conservation between 1980 and 2002. Each woman was age matched with a control residing in the same county and who have neither undergone hysterectomy nor bilateral oophorectomy.

Cox proportional hazard models and Kaplan-Meier analysis was used to calculate hazards ratios and absolute risk after taking into consideration 20 risks factors and other potential confounders.

The two cohort were followed up for a period of 22 years, and women who have undergone hysterectomy were at increased risk of obesity, hyperlipidemia, hypertension, cardiac arrhythmias and coronary artery diseases.

Women who had hysterectomy under the age of 35 years were at nearly 5 times increased risk of congestive heart failure and 2.5 times increased risks of coronary artery disease.

Dr. JoAnn Pinkerton, NAMS executive director said in a NAMS press release, “These study results suggest that alternative uterine-preserving treatments may need to be considered more often in lieu of hysterectomies, especially in benign situations. For those women having hysterectomy, hormone therapy should be considered for added protection, because ovarian function appears to be impaired by the surgery.”

Abstract

NAMS press release

Media courtesy: Detroit Free Press

A practical guide to count ovarian antral follicles by ultrasound

A consensus opinion highlighting the main techniques of ovarian antral follicle count (AFC), and providing recommendations for future research is published in special issue on Reproductive Medicine of the journal Ultrasound in Obstetrics and Gynecology.

The consensus makes several recommendations for varied methods used in counting the antral follicles, but no single method is superior over others and the choice should make best use of resources available in a particular setting.

Ultrasound imaging of ovary with several follicles: (a) two-dimensional (2D) ultrasound (US) without harmonics; (b) 2D-US with harmonics; (c) multiplanar view without volume contrast imaging (VCI); (d) three-dimensional inversion mode; (e) multiplanar view with VCI; (f) sonography-based automated volume calculation (SonoAVC).
courtesy: Ultrasound in Obstetrics and Gynecology

In the absence of a single reliable test for predicting ovarian reserve, ovarian antral follicle count serves as a good surrogate marker for it.

AFC is most often carried out in women more than 35yrs of age and already tried to become pregnant since last 6 months, diminished ovarian reserve, ovarian surgery for endometrioma, prediction of risk of fetal aneuploidy and to predict age at menopause.

AFC count is used most often in obstetric practice while ‘follicle number per ovary’ (FNPO), is often more useful in gynecological clinical practice.

The main recommendations in the consensus include:

The AFC usually include follicles with a mean diameter between 2 to 10 mm. AFC less than 5-7 indicates small oocytes will be retrieved and AFC more than 20, predicts a higher risk of ovarian hyperstimulation syndrome. AFC less than 4 indicates an increased risk of menopause in next 7 years.

The sonography for performing AFC can be carried out anytime during menstrual cycle and is not limited to menstrual period.

AFC should be performed using a transvaginal ultrasound (US) probe with frequency ≥ 7 MHz. Transabdominal route should only be employed when ovaries are situated cranially and anteriorly in pelvic cavity or transvaginal procedure is not possible.

The sonographer should undergo 20-40 supervised examination to get trained in the technique.

AFC can be performed using real-time two-dimensional (2D) US, stored 2D-US cine-loops and stored three-dimensional (3D) US datasets. The most common method using 2D-US either in real-time or stored cine-loops.

Using 3D-US, requires special machines and software and follicles are counted manually in multiplaner mode, however, rendered mode can be used particularly inversion mode or semi-automatically, using sonography-based automated volume calculation (SonoAVC™).

Standardized report consists of:

The technique used for evaluation of the follicles.

Day of the cycle and use of hormones, especially hormonal contraception.

Mention the number of follicles between 2 to 10 mm in each ovary and the total number of follicles.

Presence of dominant follicles and cysts or tumor.

It is always good to mention the accessibility of the ovaries for egg collection.

The future research might focus on reproducibility of studies that consists of storage and later evaluation of 3D datasets.

The consensus is based on expert opinions as there are very few studies focusing on AFC. There are limitations and scarcity of studies about semi-automated techniques, and an inattentive observer may report a totally different AFC. Hence, the consensus recommends manual counting of follicles in clinical practice, using any of the following techniques: real-time 2D-US, pre-acquired 2D-US cine-loops or 3D-US datasets.

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