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.

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

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.

If your bleeding is not a sign of a more serious condition, there may be a new treatment option for you to consider. It’s called tranexamic acid, and it was approved by the FDA for treatment of heavy menstrual bleeding late last year. (Tranexamic acid has been approved for treatment of other conditions since the mid-1980s.)

In tablet form, tranexamic acid is being marketed as Lysteda™. In Lysteda, tranexamic acid works by making the blood in your uterus more likely to form clots. These clots decrease the flow of blood from the lining of your womb.

Does it work?

According to studies discussed at the American Congress of Obstetricians and Gynecologists in May, more than 70% of the women who took the highest dose responded to the medication. Specifically, women with heavy menstrual bleeding who took tranexamic acid for three menstrual cycles experienced significant improvement in their quality of life.

Based on these studies, tranexamic acid is slightly more effective at reducing menstrual bleeding than nonsteroidal anti-inflammatory drugs (NSAIDs) such as Ibuprofen. On the other hand, while NSAIDs offer pain relief, tranexamic acid will not relieve any pain.

Since tranexamic acid is a non-hormonal medication, it tends to cause fewer side effects. Hormonal side effects can include depression, acne, nausea, headaches, bloating, and a decreased interest in sex. In addition, while hormonal medication must be taken almost every day, Lysteda is usually taken three or four times a day during your period.

What are the potential side effects?

Although side effects with tranexamic acid are rare, nausea and muscle cramps sometimes occur. Other possible side effects include headache, sinus and nasal discomfort, back pain, abdominal pain, joint pain, spasms, anemia and fatigue. More severe side effects have included shortness of breath, tightening of the throat and facial flushing. If you experience these side effects, you should contact your doctor.

Women who take Lysteda along with birth control pills, hormonal therapy or certain medications that affect clotting or bleeding may be at higher risk of thrombosis, which is a potentially dangerous condition that occurs when a blood clot forms inside a blood vessel. If you’re interested in taking tranexamic acid, you should let your doctor know about any other medications you’re taking.

More information

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

Additional resources

Lysteda’s home page

Abnormal uterine bleeding

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.

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.

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.