Last month another clinical study related to pelvic organ prolapse was described in the American Journal of Obstetrics & Gynecology. This study involved 108 women and compared two pelvic organ prolapse treatment approaches: laparoscopic sacrocolpopexy and total vaginal mesh.

Laparoscopic sacrocolpopexy is a procedure that uses soft synthetic mesh to support pelvic organs that have slipped out of their normal positions. The mesh is initially held in place by friction from strap-like arms of mesh material woven through the pelvis. Body tissues then grow through the mesh, creating the final support. This minimally invasive surgery takes only one to two hours. With the da Vinci Sacrocolpopexy procedure that I offer, the surgery is performed using general anesthesia.

While laparoscopic sacrocolpopexy is performed by laparoscopic access, total vaginal mesh is performed by vaginal access. Another difference is that laparoscopic sacrocolpopexy suspends the mesh from the sacrum — a large, triangular bone at the base of the spine — whereas in a total vaginal mesh procedure the mesh is suspended from pelvic ligaments.

Both procedures have been approved for several years; however, until this study was conducted in Australia, there had never been a controlled trial of this scope.

According to the article in the American Journal of Obstetrics & Gynecology, the study found that despite longer average operating time for laparoscopic sacrocolpopexy (97 minutes vs. 50 minutes for total vaginal mesh), the laparoscopic sacrocolpopexy held several significant advantages over total vaginal mesh: The laparoscopic sacrocolpopexy patients generally experienced fewer days as an inpatient, less blood loss, a shorter catheterization period and a quicker return to regular activities. More importantly, two years after surgery the laparoscopic sacrocolpopexy procedures had a success rate of 77% compared to 43% for the total vaginal mesh procedures. Finally, the reoperation rate (to treat symptoms such as further prolapse, incontinence, and mesh contraction or erosion) was 5% for laparoscopic sacrocolpopexy compared to 22% for total vaginal mesh.

I found these results particularly interesting as well as reassuring, since laparoscopic sacrocolpopexy is the primary pelvic organ prolapse treatment I offer in my practice.

More information on laparoscopic sacrocolpopexy and the da Vinci Sacrocolpopexy procedure can be found here. If you have any questions about these procedures or the symptoms they can be used to treat, please give my office a call.

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.garofaloobgyn.com. Dr. Garofalo can be reached for a personal consultation at 203.803.1098.

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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Dr. Garofalo discusses da Vinci Hysterectomy for Uterine Fibroids

I’m writing about pelvic organ prolapse again because of a recent clinical study that was set up to see if synthetic mesh inserted through a vaginal incision is beneficial in the repair of pelvic organ prolapse. This surgical procedure, called vaginal colpopexy, has been performed using sutures for many years with success rates in the neighborhood of 65-75%. These failure rates are much higher than the failure rate with da Vinci sacrocolpopexy, which I wrote about in my April blog.

Because the failure rate of vaginal colpopexy without mesh was so high, many surgeons have been adding mesh augmentation of vaginal colpopexy in an effort to improve outcomes. Unfortunately, the use of mesh for this indication had never been tested with the most rigorous of scientific studies — the randomized clinical trial — until the study referenced in this blog.

The bottom line from this study is that there were so many complications with the vaginally implanted mesh that the trial was cut short. More than 15% of the patients who received the mesh experienced a potentially serious complication called “erosion”, in which the vaginal tissue split and the mesh protruded, often causing pain and infections. These results were much more negative than the FDA’s warning in 2008 that vaginally implanted mesh complications were “rare”.

Not only were more complications found among the patients in the mesh group, there was also no improvement in success rates for the remainder of patients who had mesh placed. The success rate of surgery was the same whether or not the patient had a mesh implant. In the words of the report’s lead author, “The bottom line is not only were there more complications, but the mesh didn’t prove any better than traditional surgery.”

The alternative to surgical procedure that I recommend for pelvic organ prolapse is da Vinci sacrocolpopexy. In a sacrocolpopexy, the vaginal vault is supported by affixing it to a bone called the sacrum, located at the base of the spine. Sacrocolpopexy is also done with mesh, but it does not result in a high risk of mesh complications because the mesh is not placed through the vagina.

A recent medical report entitled Surgical Management of Pelvic Organ Prolapse in Women supported sacrocolpopexy as the gold standard for pelvic organ prolapse treatment. According to the report, sacrocolpopexy advantages include a high success rate, durability of the repair, and the essential absence of mesh complications. Since sacrocolpopexy using the da Vinci surgical technique can be done without the large abdominal incision previously used for abdominal sacrocolpopexy (discussed on this page of my website), it can be done without the need for a prolonged or painful recuperation.

I have been performing sacrocolpopexy surgery with the da Vinci surgical system with outstanding results, and I am happy that I have avoided the use of vaginally placed mesh for repair of pelvic organ prolapse. We have not seen any cases of mesh erosion in the patients who have had da Vinci sacrocolpopexy. In my  opinion da Vinci sacrocolpopexy is the best procedure for pelvic organ prolapse.

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.

Marriott Hotel, Newport, RI

October 22 – 24, 2010

Sunday October 24, 2010 – 7:30 – 8:15 am:

Uterine Fibroids – How Should We Treat Them? – Steven Bernstein & John Garofalo

Objective: Understand the treatment options for uterine fibroids

What is endometriosis?

Endometriosis occurs when a certain kind of bodily tissue – the lining of the uterus, which is also called endometrial tissue – grows where it shouldn’t. Often it can grow near the ovaries, but it can also appear on most pelvic organs. The problem is that this tissue – wherever it appears – swells with blood during your period. Your uterus expels this blood, but blood in other areas of the pelvis has nowhere to go. 

This swelling can irritate nearby tissues, which can affect your reproductive organs and your monthly menstrual cycle. It can cause cramps and pain during your periods or pelvic pain throughout the month, as well as pain during or after sex. If undetected or untreated, this irritation eventually can cause scarring, which can bind organs together and interfere with efforts to get pregnant.

About 10% of all women will suffer from endometriosis in their lifetimes – usually during their reproductive years. While any woman may develop endometriosis, the following women seem to be at an increased risk:

• women who have a mother, sister or daughter with endometriosis
• women who are giving birth for the first time after age 30
• Caucasian women
• women with an abnormal uterus (including fibroids, adhesions and abnormal uterus shape)

Although there is no known cure, endometriosis can be managed with early diagnosis and treatment.

What are the treatment options for endometriosis?

If simple pain management is not enough, if there are health risks, or if fertility is a concern, endometriosis can be treated with hormone therapy, surgery, or a combination.

Just as birth control pills do, hormone therapy regulates or suppresses the hormones that control your menstrual cycle, which limits the swelling of all your endometrial tissue. Surgery can be used to remove cut away endometrial and scar tissue and, in severe cases, to remove the reproductive organs where the stray endometrial tissue is growing. About one in five hysterectomies (surgical removal of the uterus, and sometimes the ovaries, fallopian tubes and the cervix) are performed because of endometriosis.

Here’s where da Vinci surgery comes in. As with the other da Vinci surgical procedures I’ve written about here, da Vinci surgery provides similar access to an “open” incision but there’s typically less bleeding, less pain, minimal scarring, quicker recovery, a shorter hospital stay, and a lower likelihood of complications. Whether the surgery is just to remove endometrial and scar tissue or to conduct a hysterectomy, most women can expect less pain, less scarring and a much shorter recovery period than if they had undergone open surgery. Compared to non-remote-controlled laparoscopic surgery, da Vinci endometriosis surgery provides far greater access, precision and control.

It’s important to remember that surgery – even a hysterectomy – may not permanently remove endometriosis. After surgery, about 15-20% of patients have endometriosis symptoms again within five years. However, surgery can be combined with hormone treatment to manage endometriosis.

Here’s a quote from a woman who was treated for endometriosis using da Vinci surgery.

“I spent 24 hours in the hospital. I was home by noon the next day. I walked into my house on my own, took a shower, made myself a ham and cheese sandwich and checked my e-mails. The only pain medication I took was a couple of Ibuprofen.” – Penne, California

This quote and others can be found on www.davincistories.com.

More information

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

Links to da Vinci surgery resources

da Vinci surgery

da Vinci endometriosis surgery

da Vinci surgery patient stories

Dr. Garofalo’s da Vinci information page

Dr. Garofalo’s da Vinci endometriosis information page

Dr. John Garofalo, M.D., is a certified da Vinci surgeon 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.

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.

Prolapse literally means “to fall out of place”. When pelvic organ prolapse occurs, organs such as the uterus or bladder fall down or slip out of place, often pushing into or through the vagina. Pelvic organ prolapse can be uncomfortable and it can interfere with urination, bowel movements and sexual activity.

Going back just a decade or so, the most common treatment options for serious pelvic organ prolapse cases were relatively limited. Reconstructive surgery was one option, and hysterectomy was another. Today, an increasingly common option is called sacrocolpopexy. This is an open surgery in which soft synthetic mesh is used to permanently hold the vagina in the correct anatomical position. After the surgery, your body creates tissue that grows through and around the mesh, helping to restore your anatomy to its natural position and reinforcing the structures around your vagina to maintain support.

This is where da Vinci technology comes in. Instead of the 15-30 cm incision needed for a “regular”, open-surgery sacrocolpopexy, the da Vinci system uses five very small abdominal incisions and state-of-the-art computer technology to convert my hand movements into precise movement of the da Vinci surgical instruments. The procedure usually takes only one or two hours.

As with other da Vinci procedures, da Vinci sacrocolpopexy can provide several advantages. Compared to open abdominal surgery, there’s typically less bleeding, less pain, minimal scarring, quicker recovery, a shorter hospital stay, and a lower likelihood of complications. After a da Vinci sacrocolpopexy, most women usually return home the next day. Many women resume most normal daily activities within four days and recover in two to three weeks, although heavy lifting, strenuous exercise and sexual intercourse should be avoided for up to six weeks.

Sacrocolpopexy also can be performed as a preventative measure. If you or someone you know has decided to have a hysterectomy, sacrocolpopexy can be done after the hysterectomy to provide long-term support of the vagina.

Here are a few quotes from women who have had da Vinci sacrocolpopexy. These quotes and the stories behind them can be found on www.davincistories.com.

“I had a problem with uterine prolapse and urination. I am 100% better after having da Vinci Surgery. Recovery was very fast. There was no pain or discomfort. I was back to work in three weeks, but I could have gone back sooner. I would definitely recommend this surgery to anyone who needs it. It was a breeze.” – Velma, Norwalk CT

“I would not think twice about having another surgery with the da Vinci surgical method. I cannot tell you how pleased I am with my outcome, and I am only five days post-op.” – Diane, North Haven CT

If you live in Connecticut, Dr. Garofalo is a gynecologist serving the Stamford and Bridgeport metro areas.

da Vinci myomectomy

In my last blog I wrote about hysterectomy (surgical removal of the uterus) and how this surgery is well-suited for surgery using the da Vinci approach. One of the main reasons a woman might consider a hysterectomy is the presence of uterine fibroids, which are non-cancerous tumors that grow out from the muscle layer and connective tissue in the uterus. Uterine fibroids (also called leiomyomas or myomas) are very common, especially during a woman’s middle and later reproductive years: about 20-40% of women will be diagnosed with uterine fibroids at some point in their lives.

In most cases uterine fibroids are harmless. But sometimes they can cause heavy and painful menstruation, painful sexual intercourse, and urinary frequency and urgency. Uterine fibroids that are located inside the uterine cavity can make it difficult or impossible to conceive a child, and they can cause complications in pregnancy, including bleeding, miscarriage, premature labor, or interference with the position of the fetus.

If you or someone you know has problems with uterine fibroids, there are several options for treatment. In some cases, simple observation or medication may be enough. Hysterectomy is another option. But in certain cases, especially if you’re trying to get pregnant, myomectomy (surgical removal of uterine fibroids) may be worth considering, especially because myomectomy preserves the uterus for reproduction. Similar to the da Vinci hysterectomy, da Vinci myomectomy uses small incisions in the abdomen. From a nearby console, I control cameras and various surgical instruments to expose and remove the fibroids. Once the removal is complete, the incisions in the uterine wall and the abdomen are closed and sealed.

As I’ve mentioned in my other blogs, the da Vinci approach allows precision and control that’s crucial when working in close proximity to delicate organs. Compared to open abdominal surgery, there’s typically less bleeding, less pain, minimal scarring, quicker recovery, a shorter hospital stay, and a lower likelihood of complications. After a da Vinci myomectomy, most women will require an overnight hospital stay and should be able to resume normal activities within two  weeks – about three times faster than recovery from an open procedure.

Here are a few quotes from women who have had da Vinci myomectomies. These quotes and the stories behind them can be found on www.davincistories.com.

“da Vinci Surgery is really rather pleasant (as surgery goes). I woke up with nothing but Band-Aids on my tiny wounds. I also immediately felt the absence of my fibroid. I have no more wicked pains during menstruation, so I am really glad I had this surgery. I’d highly recommend it. I am better than new now.” – Lisa, White Plains NY

“[My fibroid] was removed without leaving big scars on my body and leaving me in bed for weeks. Additionally and most importantly, my fertility was not affected.” – Ivanice, Montclair NJ

“I was amazed at how quick the recovery was. It was done as an outpatient procedure, and I was out of the hospital the next day. – Deniza, Syracuse, NY

More information

If you’d like more information, including a video description of the procedure, go to this page on my website. The testimonial video links are on the left:

http://www.garofaloobgyn.com/uterine_fibroids.html

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

In my next blog, I’ll write about another condition called sacrocolpopexy that can also be treated using da Vinci.

Links to da Vinci surgery resources

daVinciSurgery.com

da Vinci Myomectomy

da Vinci Surgery Patient Stories

Dr. Garofalo’s da Vinci information page

Dr. John Garofalo, M.D., is a certified da Vinci surgeon and OB-GYN in Norwalk, CT and sees patients throughout Fairfield County including Norwalk, Westport, Stamford, Bridgeport 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.