FOR IMMEDIATE RELEASE
April 11, 2011

Norwalk, CT – Today John Garofalo, M.D. was admitted to the Registry of the Council of Gynecologic Endoscopy (CGE) with certification at the highest level of competence in Operative Laparoscopy and Operative Hysteroscopy. He is now one of a select group of Connecticut and Fairfield County physicians to be listed on the Registry. With this certification, CGE recognizes Dr. Garofalo’s experience conducting endoscopic surgeries that led to successful medical outcomes.

Endoscopic surgical procedures performed by Dr. Garofalo include hysterectomy (removal of the uterus), myomectomy (removal of uterine fibroids), sacrocolpopexy (abdominal vault suspension) and endometrial ablation (a procedure performed to treat abnormal bleeding of the uterus).

About CGE

CGE’s mission is to identify endoscopic surgeons and to encourage high standards for gynecologic endoscopy and minimally invasive surgery. As an example, laparoscopic hysterectomy, a minimally invasive procedure which can reduce surgery length, hospital stay, recovery time, pain and the likelihood of complications relative to traditional “open” hysterectomy, is used for only 15% of the 600,000 hysterectomies performed annually in the United States. By offering accreditation, CGE seeks to get more ob/gyns to use endoscopic procedures and, by raising the visibility of endoscopic techniques, to encourage more patients to demand them.

Formerly known as the Accreditation Council for Gynecologic Endoscopy, CGE is devoted to advancing knowledge and effective use of minimally invasive gynecologic surgery. CGE retrospectively reviews physicians’ case lists and randomly selected operative and pathology reports. Physicians whose case lists support the types of surgery they are performing are included as members and are listed in the registry. Surgeons who consider themselves gynecological endoscopic surgeons and can demonstrate sufficient case documentation may apply to be included in the registry, which includes only 1,100 gynecologic surgeons worldwide.

About AAGL

CGE is a professional interest partner of the American Association of Gynecologic Laparoscopists (AAGL), a not-for-profit professional medical association of doctors dedicated to the research and advancement of minimally invasive gynecologic procedures. Founded in 1971, AAGL has approximately 4,000 members located in more than 60 countries around the world. It is the first and largest organization in the world dedicated to advancing the safest, most efficacious and least invasive diagnostic and therapeutic techniques to treat women’s pelvic health disorders. The AAGL’s commitment to women’s health care, which historically has been embodied in the integration of clinical practice, research, innovation, dialogue and continuing education of physicians, now encompasses outreach to and education of patients. More information on AAGL and CGE can be found at www.aagl.org and www.aagl.org/CGE.

About John Garofalo, M.D.

Dr. John Garofalo, M.D., is a gynecologist located in Fairfield County, Connecticut. He is also the Associate Director of Gynecology at Norwalk Hospital. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com or call 203.803.1098.

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There are two types of IUDs available today: the kind that contains copper instead of hormones, and the ones that contain progestogen, a synthetic hormone. This second kind is marketed by Bayer as Mirena.

One significant side effect of birth control pills and other hormonal birth control methods is that they may reduce heavy menstrual bleeding. (In fact, while the FDA approved Mirena for birth control in 2000, it was approved last year for reducing heavy menstrual bleeding.) The hormone levels in the prescription may have to be adjusted to achieve this effect, and the hormones may even cause light bleeding at other times of the month, but hormonal contraception is a common method of suppressing menstrual bleeding.

More than just an inconvenience, heavy menstrual bleeding can cause iron-deficiency anemia and otherwise affect your quality of life. Some women even seek surgery to reduce or eliminate bleeding, and while surgery generally works, it can also cause unpleasant side effects or cause complications.

Mirena vs. The Pill

If you’re prone to heavy menstrual bleeding and trying to decide between birth control approaches, which one is best for your needs? I can’t answer that in this blog, since it really depends on your lifestyle and other factors, but I can tell you about a recent study that set out to determine which approach reduced bleeding more — Mirena or birth control pills.

This study, which relied on 165 women over a six-month time period, found that while 22% of the women who took the birth control pill experienced a 50% or more decrease in their usual amount of bleeding, the percentage was much higher women among women with the Mirena IUD: almost 85%. After six cycles, the birth control pill group had experienced an average 21.5% reduction in menstrual bleeding, while in the IUD group averaged a reduction of almost 71%.

Other things to consider

Keep in mind that there are other reasons to choose one of these birth control approaches over the other. You could experience side effects such as headaches with either approach, for example, and Mirena is not appropriate for some women with abnormal uterine conditions.

Another thing to consider is that if you’re prone to forget taking pills, an IUD might be more effective. IUDs are generally used for five years and then should be replaced.

Also, keep in mind that birth control pills and IUDs do not prevent sexually transmitted diseases, so women in non-exclusive relationships should consider other birth control methods such as condoms instead of or in additional to IUDs or birth control pills.

Finally, if you’re experiencing heavy menstrual bleeding and you haven’t discussed it with a physician, be sure to make an appointment to have your condition checked. Your bleeding could be a symptom of a more serious condition.

Links to Mirena IUD resources

Bayer Healthcare Pharmaceuticals’ Mirena information page

Dr. Garofalo’s webpage on abnormal uterine bleeding

Dr. Garofalo’s webpage on well woman care

Dr. John Garofalo, M.D., is gynecologist located in Fairfield County, Connecticut. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

PMS and menopause 

Hormonal changes caused by PMS and menopause can cause a wide variety of symptoms, including cramps, irritability, mood swings, weight gain and bloating. Some of these symptoms may be managed by taking vitamins, minerals or supplements. But you should be aware that information on these products can be sketchy and incomplete. In addition, quality can be poor, inconsistent, and even dangerous. For example, while tryptophan has been shown to alleviate some PMS symptoms, there have been instances of tryptophan contamination in the past, and the safety of tryptophan’s manufacturing process is still in question.

How could this happen?

Unfortunately, government oversight of supplements is extremely lenient, due to permissive regulations and the FDA’s limited resources. While pharmaceutical drugs must demonstrate safety and effectiveness before they go on sale, there is no such process for supplements. In fact, because supplements are considered neither a food nor a drug, there is no government approval process at all for dietary supplements. The FDA can act only after consumers get sick or a safety issue is reported.

Mystery Ingredients

Certain supplements have been found to contain not enough or too much of various ingredients. Some contain undeclared and potentially dangerous ingredients such as bacteria, toxic plant material and heavy metals. Even more alarming has been the presence of prescription medications, controlled substances and untested experimental compounds. These substances have included everything from diuretics, which can cause dehydration and potassium deficiency, to amphetamines, which can lead to depression and addiction.

Untested chemical modifications

Some companies that make these kinds of products have also been known to modify ingredients’ chemical structures in order to evade detection or reduce the risk of patent infringement lawsuits. This kind of chemical tinkering has allowed some companies to disguise drugs such as fenfluramine, which was used in Fen-Phen and was withdrawn from the U.S. market in 1997 after reports of heart disease.

How can you identify contaminated supplements?

Unless you have a clinical lab at your disposal, it’s very difficult to identify contaminated supplements. Although many are manufactured in China, they aren’t just made overseas or found only on the Internet. Earlier this year, a California-based company pleaded guilty to selling anabolic steroids labeled as weight loss supplements. Many supplements that were found to be contaminated were purchased in mainstream retail stores in the United States.

Why should I tell my doctor?

There are several reasons why you should let your doctor know if you’re taking or considering dietary or nutritional supplements, even if they’re labeled as “Natural” or are made by a reputable company. If your physician knows what you’re taking, he or she will be more likely to correctly diagnose any related side effects and let you know any potential adverse interactions with pre-existing conditions or other drugs you might be taking. More importantly, your physician may be more likely to identify a suspicious or dangerous product. 

More information

If you need additional information, you can click on any of the links below or you can contact my office directly.

U.S. Food and Drug Administration Q&A

The New England Journal of Medicine article

Informed Choice supplement contamination study results

Dr. John Garofalo, M.D., is a certified OB/GYN in Fairfield County, Connecticut. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

In my last blog I wrote about Essure, a relatively new procedure that offers a highly effective option for permanent birth control. One of the best ways to evaluate whether or not a medical procedure is right for you is to look at it in terms of its risks and benefits. Here are some more questions and answers that I hope will help you with your decision.

Is the Essure procedure effective?

While no form of birth control is 100% effective, fewer than one in 100,000 pregnancies occur when tubal blockage has been confirmed by the three-month test. The Essure procedure is the only birth control method with zero pregnancies in clinical trials.

Is the Essure procedure safe?

Studies have shown that the Essure procedure is safe. However, as with most birth control methods, there are risks. In some cases one or both Essure coils may not place properly in the Fallopian tubes and may have to be re-applied.

Is the Essure procedure painful?

In most cases the pain of an Essure procedure is far less and shorter-lasting than the pain often associated with a surgical procedure such as tubal ligation. Symptoms during or immediately after an Essure procedure may include mild to moderate cramping, nausea, vomiting, dizziness and bleeding. However, pain from the procedure is usually relatively mild. In a medical study published in 2005, 72 women who were surveyed immediately after undergoing the Essure procedure said the pain they felt was slightly less on average than the pain they experienced during their menstrual cycle.

How long does the Essure procedure take?

Essure patients are asked to arrive an hour before the procedure time. Once inside the examination room, the cervix is numbed and the uterus is filled with a liquid saline solution. The next step, insertion of the coils into the Fallopian tubes, takes about 10 minutes. The three-month test usually takes about an hour.

How long does Essure procedure recovery last?

Most women return to their normal activities in less than a day.

How quickly does the Essure procedure work?

It usually takes about three months for the Essure treatment to completely block both Fallopian tubes. During this time, women should continue to use a backup form of birth control. After three months, the Essure procedure’s effectiveness is tested using an HSG (hysterosalpingogram) test, which uses dye to test the seal. In some cases it may take six months or longer for the Fallopian tubes to become completely obstructed.

Will the Essure procedure affect my monthly cycle?

Unlike many temporary methods of birth control such as birth control pills, the patch and some IUDs, the Essure coils do not contain hormones. They will not interfere with your monthly cycle.

Is the Essure procedure covered by my insurance?

Essure procedures are covered by most insurance providers. If the procedure is performed in a doctor’s office, a co-pay may be all you need to pay. My office can work with you and your insurance company to determine what your insurance company will cover.

How does the Essure procedure compare to getting your tubes tied?

Tubal ligation, or “getting your tubes tied” is a procedure that involves severing Fallopian tubes or pinching them shut. It can be done via cutting or burning the Fallopian tubes, or by using rings or clips that restrict part of the Fallopian tubes. The procedure usually takes one to two hours, with general anesthesia. It’s usually done in a hospital or a clinic.

The Essure procedure is different from tubal ligation in that it does not involve cutting, it does not require general anesthesia, and it usually takes about 10 minutes. More than half of all Essure procedures are performed in a doctor’s office.

More information

If you’d like additional information, you can click on any of the links below, or you can contact my office directly.

Links to Essure resources

Essure’s home page
Essure patient and physician testimonials
Essure patient information booklet pdf
Essure confirmation test booklet pdf
Dr. Garofalo’s webpage on permanent birth control and Essure
Dr. Garofalo’s Essure consent form pdf

Dr. John Garofalo, M.D., is a gynecologist located in Fairfield County, Connecticut. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

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Lately I’ve been getting a lot of questions from my patients about the Essure birth control procedure. Maybe it’s because of the recent publicity from Olympic gold medalist Picabo Street, who announced earlier this year that she’d undergone the procedure. In any case, I thought I’d answer some of the most common questions I’ve heard. I’ve also included some useful links at the bottom of this blog.

What is Essure?

The Essure procedure is a permanent birth control method developed by an American company called Conceptus. Essure is their main product.

During the procedure, tiny flexible coils made out of polyester fibers, nickel-titanium and stainless steel are passed by a small tube called a catheter from the vagina through the cervix and uterus and into the Fallopian tubes. (Fallopian tubes are two very thin tubes that lead from the ovaries into the uterus.) Once in place, the Essure coils cause tissue growth (scarring), which seals a portion of the Fallopian tubes. This tissue barrier prevents sperm from reaching the ovaries.

How long has the Essure procedure been used?

Hundreds of thousands of women have had the Essure procedure, which was approved for use in the United States in 2002. I’ve been conducting Essure procedures for several years.

While the Essure procedure is relatively new, Essure coils are made from materials that have been used successfully for many years in cardiac stents and other medical devices that are placed in the body.

Is the Essure procedure permanent?

According to the manufacturer, the Essure procedure is intended to be permanent and non-reversible. However, as of last month, less than two dozen successful Essure reversals have been performed – all in the past three years – and the first “Essure reversal baby” was born just a few months ago.

Before having the Essure procedure, you should be sure that you do not want to have any more children.

Is the Essure procedure right for me?

Most women are candidates for the Essure method, but sometimes the coils cannot be placed due to issues such as prior tubal blockage, fibroids distorting the uterine cavity, or uterine septum (when a wall of tissue divides part or all of the uterus). In addition, the Essure procedure is not recommended for women who:

• are pregnant or have been pregnant in the past six weeks
• are not certain they are finished having children
• have had a recent infection in the pelvis
• have serious, chronic health problems
• are allergic to contrast dye or nickel
• are taking corticosteroids (a type of anti-inflammatory drug)

If you’ve had any of these conditions, we can discuss whether Essure is appropriate for you.

Tune in next week …

In my next blog I’ll write about the Essure procedure’s risks and benefits, and how it compares to another procedure, called tubal ligation – or “getting your tubes tied”.

More information

If you’d like additional information, you can click on any of the links below, or you can contact my office directly.

Links to Essure resources

Essure’s home page
Essure patient and physician testimonials
Essure patient information booklet pdf
Essure confirmation test booklet pdf
Dr. Garofalo’s webpage on permanent birth control and Essure
Dr. Garofalo’s Essure consent form pdf

Dr. John Garofalo, M.D., is gynecologist located in Fairfield County, Connecticut including Bridgeport, Norwalk, Stamford, Westport and Danbury. For more information on Dr. Garofalo and his medical practice, go to www.garofaloobyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

Although many of my patients were initially resistant to the concept of wearing a vaginal ring, well over 90% of my patients who have tried the ring have been very satisfied with their contraceptive choice. The Nuvaring is easy to place and remove and it does not interfere with spontaneity or intercourse. You will not even know it is there and your partner will probably not know either- and if he does notice something, it won’t bother him. The Nuvaring cannot get lost inside of you and it rarely slips out. When properly used, the Nuvaring is 99% effective.

For more information, go to the Nuvaring website at http://www.nuvaring.com/Consumer/index.asp or schedule an appointment with me for personalized contraceptive counseling.

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Patients occasionally ask me about the safety and effectiveness of  Bioidentical Hormone Replacement Therapy (“BHRT”). They point out that they can get natural hormones in personalized doses based upon levels of hormones in their saliva. They are told by compounding pharmacies and their marketers that BHRT

• is a safer, natural alternative to dangerous prescription drugs
• is superior to FDA-approved hormone therapies
• can slim you down by reducing hormone imbalances
• can prevent senility, Alzheimer’s disease, stroke, and various cancers

It sounds great, doesn’t it?

The truth is that there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones. There is also no scientific support for the use of hormone assays from salivary, urine or blood for the adjustment of hormone replacement dosage.

With the approach of menopause, decreasing estrogen levels may be associated with hot flashes, vaginal dryness, poor memory, insomnia and osteoporosis. Treatment with estrogen and progesterone (HRT) can relieve these symptoms and help prevent osteoporosis. The benefits of HRT are accompanied by an increase in the risk of cardiovascular disease and breast cancer. Because of these risks, the FDA requires that pharmaceutical companies manufacturing HRT include appropriate warning labels within the packaging of all these medications. The American College of Obstetricians and Gynecologists (ACOG) recommends that HRT should only be used for relief of severe menopausal symptoms that do not respond to natural methods or non-hormonal medications. HRT should be used at the lowest effective dosage for the shortest possible period of time.

In order to get initial FDA approval for sale and marketing of HRT preparations, pharmaceutical companies were required to produce scientific evidence supporting the safety and efficacy of their product. The FDA also mandates ongoing monitoring of the manufacturing processes and reporting of adverse drug events. BHRT, on the other hand, is not made by pharmaceutical companies; it is made by compounding pharmacies that are not subject to the rigors of FDA regulation. The bottom line is that because BHRT preparations have not undergone rigorous clinical testing for safety or efficacy, we really do not know if these preparations are either safe or efficacious. Important decisions about one’s health should not be based on what seems like a good idea. Safety and efficacy claims must be based on the best available scientifically derived evidence and must be reevaluated in the light of emerging data.

Your decision of whether or not to take hormone therapy for menopausal symptoms is highly individualized, based on your health, risk factors, and personal wishes. You should be sure to have all the information you need in order to make an informed decision.

For more information on bioidentical hormones:

Click here for an article from the FDA   http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm

Click here for an article from the American College of Obstetricians and Gynecologists http://www.acog.org/from_home/publications/press_releases/nr02-03-09.cfm)

For more information about salivary testing for hormone levels:

Fugh-Berman A et al. Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme. J. Gen. Internal Med. 22: 2007.  http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2219716

Chatterton RT Jr, Mateo ET, Hou N, et al. Characteristics of salivary profiles of oestradiol and progesterone in premenopausal women. J Endocrinol 2005;186:77-84.  http://www.ncbi.nlm.nih.gov/pubmed/16002538

John M. Garofalo, MD