Hysteroscopic management of symptomatic cesarean scar defects

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The incidence of cesarean scar defect is on the rise with a rising cesarean delivery rate. According to the Center for Disease Control, the current cesarean section rate in the US is 31.9%.

For many years, cesarean scar defect was an accidental finding on hysterosalpingogram and pelvic sonogram, but since last two decades, it has been associated with post-menstrual spotting and bleeding.

The collected blood may result in inflammation leading to chronic pelvic pain, dysmenorrhea, dyspareunia, and vaginal discharge. It also causes secondary sterility possibly because of change in the endometrial milieu which lead to altered cervical mucus, sperm transport and interfere with embryo implantation. It is also responsible for obstetrical complications including abnormal placentation, scar dehiscence, and uterine rupture.

It was in the early 2000s when studies reported resolution of symptoms following surgical management of the defects. Three different routes have been described for the surgical management of cesarean scar defect or isthmocele: laparoscopic; hysteroscopic (when the residual myometrium is equal to or > 3 mm); and vaginal.

No randomized controlled trials have been published to establish the efficacy of one method over another. Some surgeons favor the hysteroscopic method because of its minimally invasive nature, quick recovery, and better resolution of symptoms. Complications involve injury to bladder, incomplete repair and persistence of symptoms.

To avoid these complications most surgeons, prefer this method when the residual myometrium is 3 mm thick or do the repair under ultrasound guidance. A randomized trial by Vervoort et al., comparing hysteroscopic repair vs., expectant management has shown significant improvement in pain and post-menstrual spotting after the repair.

Gubbini et al., have published two case series evaluating the efficacy of hysteroscopic repair of isthmocele in the resolution of postmenstrual symptoms and treatment of secondary infertility.

In the first series all 41 patients (100%) patients conceived with 24 months of completion of hysteroscopic isthmocele repair and in the second series, 26 patients with the defect underwent repair, of whom 7 out of 9 patients with secondary infertility became pregnant.

Those doing laparoscopic repair argue that this approach results in complete and proper resection of the scar tissue followed by the proper approximation of the overlying myometrium. Antagonists argue that the procedure is more invasive and has the inherent risk of bladder injury during separation along with incomplete resolution of symptoms. Evidence so far has demonstrated both methods to be equally effective in reducing symptoms and improving fertility.

In the August issue of Journal Fertility and Sterility, Sanders and Murji have presented two case series with a meticulous video showing hysteroscopic resection of the cesarean scar defect. The video begins with definition, symptoms, and identification of cesarean isthmocele and then proceeds to describe the two cases.

The video systematically identifies the anatomy, resecting the defect cephalad and then caudad, and ablation of the defect at its base.

Here is the video about Hysteroscopic Repair of Cesarean Scar Isthmocele

Flashback: Laparoscopic repair of Cesarean Scar Isthmocele

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North American Menopause Society (NAMS) video series about important midlife health topics: Nonhormone Prescription Options for Hot Flashes

The North American Menopause Society (NAMS) provides practical information on important midlife health topics for women. All the interviews in the series are hosted by NAM Board of Trustees Member and Immediate Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also the medical consultant for CTV News.

HRT remains the most effective solution for the relief of menopausal hot flashes but not all women want to use hormones, or it may be contraindicated in some as women with breast cancer. Fortunately, there are some non-hormonal therapy that provide some relief, although they may not be as effective as estrogen.

In this informative video of 2018 series, Dr. Shapiro interviews Dr. James Simon, Clinical Professor, Department of Obstetrics and Gynecology, the George Washington University School of Medicine. Dr. Simon explains the efficacy of nonhormone options for hot flashes.

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FlexDex intuitive laparoscopic accompaniments to begin sale in the US

Introduction of FlexDex intuitive technology has revolutionized the way minimal invasive surgeries are performed by lending the ease of movements and intuitive control than traditional laparoscopic instruments.

Using the ‘virtual center,’ the platform precisely translates the movement of surgeon’s wrist, hand, and arm outside the patient’s body into the corresponding movements of the instrument tip inside the patient body. Unlike any other instrument, it allows the surgeons to move the wrist in the direction of intended movement thereby greatly simplifying the execution of the surgical procedure.

Until now, FlexDex only provided the technology to a few hospitals as part of clinical trials. Now, FlexDex has entered into exclusive distribution agreement with Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures to distribute FlexDex’s Needle Driver instrument in the United States.

The agreement combines Olympus’ innovative 3D laparoscopic imaging technology and FlexDex’s wristed needle-driver to offer a low-cost, robust alternative for complicated high-cost robotic set-up.

Randy Clark, Group Vice President of the Surgical Division at Olympus said in a news release, “Combining Olympus’ expertise in minimally invasive surgery and 3D technology with FlexDex’s unique technology for handling surgical instruments -- without the complexity and cost of a computer-aided robotic system -- will be a game changer for physicians and patients. We are thrilled to add FlexDex to the Olympus portfolio, furthering our progress of improving patient satisfaction, decreasing costs and improving the quality of life for patients.”

“Hospitals are constantly under pressure to reduce cost and improve patient outcomes. Using a multi-million-dollar robotic system for procedures that have low margins, often associated with fixed reimbursement, can potentially further burden providers financially. FlexDex and Olympus are uniquely positioned to offer surgeons the precision and control they desire while maintaining the balance of cost, outcome and patient benefit,” added Dr. James Geiger, CEO at FlexDex.

Flashback: FlexDex, a revolutionary laparoscopic technology that moves like surgeon’s hand

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FDA clears Sonata ultrasound system for transcervical, incision-free, uterus-preserving treatment for uterine fibroids

Gynesonics, a women’s healthcare company located in Redwood City, CA received FDA clearance for its Sonata (Sonography-Guided Transcervical Fibroid Ablation) System ® for non-invasive, transcervical, uterus-preserving treatment for symptomatic uterine fibroids. The Sonata System has CE Mark and is already approved for sale in the European Union.

The Sonata system combines a miniature, reusable, high-resolution intrauterine ultrasound probe (IUUS) with a single-use disposable Radiofrequency Ablative (RFA) handpiece with an introducer and needle electrode array.  The RFA handpiece is equipped with a proprietary Graphical Guidance Software (GGS) provides the operating gynecologist with real-time graphics overlay on the live ultrasound image for selecting the deployment length, width and position of the ablation guide.

The RFA handpiece and IUUS probe lock together to form a single system for an incision-free approach to the outpatient treatment of symptomatic fibroids. 

Once the fibroid is identified by the IUUS probe, the GGS projects the ellipsoidal region where the ablation will take place (ablation zone), along with a surrounding ellipsoid (thermal safety border) where tissue temperatures will be elevated. The tissue outside the safety border remains safe during the procedure.

After securing the correct location of the needle electrodes and selecting the ablative zone, RF energy is delivered to the fibroid according to a fixed treatment cycle that is dependent on ablation size. The duration and temperature of the procedure are automatically set by the software based on the size of the fibroid.

The Sonata System can create a continuous zone of ablation from 4.0 cm wide and up to 5.0 cm long, and multiple such zones can be created within a single fibroid.

Unlike operative hysteroscopies, the system does not require continuous irrigation or distention of the uterine cavity. Only a little hypotonic solution is introduced in the cavity for acoustic coupling of the ultrasound probe.

The diameter of the treatment device is 8.3 mm which includes both the IUUS probe and RFA handpiece attached to one another and is compatible with cervical dilatation of 27 French.

Other potential devices can be attached to the IUUS probe to provide additional functions beyond ablation.

The Sonata System is designed to wholly or partially ablate fibroid types 1,2,3,4,5,6 and 2-5 by the PALM-COEIN classification system developed by the International Federation of Gynecology and Obstetrics (FIGO). 

The FDA clearance is based on results of pivotal prospective, longitudinal, multicenter IDE trial (NCT02228174). A total of 147 patients were enrolled at 22 centers in the U.S. and Mexico. All patients underwent transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.

The results of the trial showed that 99% of study patients did not require any surgical reintervention at 12 months. A total of 94% of patients treated with the Sonata reported a reduction in bleeding, with 64% achieving a more than or equal to 50% reduction in bleeding.

The system has a 97% patient satisfaction rate with the most patient returning to the regular activity about 24 hours after the procedure.

Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford, CT a principal investigator in the SONATA trial, stated, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”

With its ability to ablate most types of uterine fibroids and preserve the uterus, the Sonata System represents an exciting new technology for the treatment of uterine fibroids.

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Media courtesy: Gynesonics, Current obstetrics and gynecology reports

Hologic unveils Fluent fluid management system that simplifies and streamlines hysteroscopies

Hologic launches its new Fluent™ fluid management system to streamline the liquid distention of the uterus during diagnostic and operative hysteroscopy and measure the volume of irrigation fluid in and out of the uterus.

The system is easy to set-up and the user-friendly interface prompts the operator through all the steps to set-up and wraps the operation. The screen provides large visual and audible alerts during monitoring of fluid deficit, pressure, low fluid bags, and full waste bags to keep the procedure running smoothly.

The system is sensitive enough to detect a change in average intrauterine pressure of less than 1% and fluid deficit within +/- 50 mL when running the MyoSure® system. A single waste bag eliminates the need of multiple canisters.

"We developed the Fluent system with a deep understanding of the hectic workflow that often characterizes the patient and staff experience," said Sean Daugherty, President of GYN Surgical Solutions, Hologic. "This launch is a testament to how our strong customer partnerships and unique technological innovations enable us to provide healthcare professionals with the advanced equipment they need to improve lives."

"Fluid management plays a vital role in gynecological procedures, yet there have been few advances in the technology," said Edward Evantash, M.D., Medical Director and Vice President of Global Medical Affairs, Hologic. "The Fluent system is changing the game in fluid management. Developed in response to the challenges facing nurses and doctors performing hysteroscopies, it combines a streamlined design with innovative technology for more efficient fluid monitoring during procedures."

Here is a video about how the Fluent system untangles your fluid management experience

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FDA clears Annovera, the first vaginal birth control ring that prevents pregnancy for a year

The US Food and Drug Administration (FDA) has recently approved Annovera™ (The Population Council, Inc), the first long-acting combined hormonal vaginal ring contraceptive that can be used for an entire year.

Annovera is a donut-shaped, reusable, nonbiodegradable, white opaque, flexible vaginal ring containing two active ingredients: low doses of a novel progestin, Nestorone® (segesterone acetate), with a widely used estrogen (ethinyl estradiol).

It must be placed in the vagina for 3 weeks and then removed for 1 week during which women experience a withdrawal bleeding. Each ring releases approximately 0.15 mg/day of segesterone acetate and 0.013 mg/day of ethinyl estradiol over the 3 weeks period of active use.

The removed ring is cleaned with mild soap and warm water patted dry and placed in its case during the one-week dose-free interval. At the end of the dose-free interval, the vaginal system should be cleaned prior to being placed back in the vagina for 3 complete weeks cycle.

The schedule is repeated every 4 weeks for 1 year, covering 13 menstrual cycles of 28 days each.

Victor Crentsil, M.D., acting deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research said in a press release, “The FDA is committed to supporting innovation in women’s health and today’s approval builds on available birth control options.”

The approval of Annovera is based on results of 17 clinical trials that include safety and efficacy data from three, open-label clinical trials which included 2,308 healthy women ranging from 18 to 40 years of age. Based on the results, Annovera was 97.3% effective in preventing pregnancy when used as directed.

The ring carries a boxed warning about the serious risk of a cardiovascular event in women who smoke and are over the age of 35. Annovera is contraindicated in women who are at high risk of arterial or venous thrombotic diseases, current or history of breast cancer or other estrogens- or progestin-sensitive cancers; liver tumors, acute hepatitis, or decompensated cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of Annovera; and use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Most common side effects are similar to other combined oral contraceptives that include headache/migraine, nausea/vomiting, yeast infections, abdominal pain, dysmenorrhea (painful menstruation), breast tenderness, irregular bleeding, diarrhea and genital itching.

The FDA will further evaluate Annovera based on the results of post-marketing studies for risk of venous thromboembolism and the effects of CYP3A modulating drugs and tampon use on the pharmacokinetics of Annovera.

The Population Council announced a license agreement with TherapeuticsMD, an innovative healthcare company focused exclusively on women’s health, to make Annovera available to women in the U.S. Under the terms of the license agreement, TherapeuticsMD will provide Annovera at significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women. TherapeuticsMD currently estimates Annovera will be commercially available as early as the third quarter of 2019 and commercially launched as early as the fourth quarter of 2019 or first quarter of 2020.

FDA press release

Population Council press release

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Kangaroo mother care: a simple, smart, no-cost investment in our children’s future

courtesy:HNN   

Kangaroo mother care (KMC) refers to the practice of providing continuous skin-to-skin contact between mother and baby, exclusive breastmilk feeding, and early discharge from the hospital. It helps save millions of preterm babies in poor resource setting by regulating the baby’s temperature, speeding up the weight gain, and reducing the risk of infections.

KMC was first introduced in Bogotá, Colombia by two pediatricians Dr. Rey and Dr. Martinez in 1970s following increasing preterm morbidity and mortality.

Both the pediatricians were deeply troubled by the lack of incubators in poor resource settings and while looking for solutions were inspired by the way mother kangaroo care for their young ones.

Born immature, about 1-inch long and weighing less than a gram, the baby kangaroo immediately crawls up the mother’s body to enter the pouch. Once inside, they attach to one of the four teats to get nourishment, warmth and develop to become active and independent.

Years later, many studies and meta-analysis have proven the benefits of kangaroo care. A 2015 study has shown a 36% reduction in mortality for preterm babies who receive kangaroo care vs. conventional neonatal care. Adopted on a national scale in Rwanda, it has brought down neonatal mortality by 30% between 2008 and 2015.

The World Health Organization recommends KMC for the routine care of newborns weighing 2000 grams or less at birth. However, surprisingly a tiny percentage of newborns who could benefit from kangaroo care receive it.

KMC day is celebrated on May 15th

Country-level adoption and implementation are very poor. It is often considered as “ second best” to incubator care. Every year, about 2.7 million newborns die during their first month of life, the majority occurring in parts of the world where there are no hospitals or clinics nearby, and no access to skilled birth attendants. These areas could greatly benefit from the adoption of kangaroo care.

KMC also has long-term cultural, social and behavioral benefits for our society. A recent study noted that this practice is a gift whose value keeps on multiplying over time.  Parents that practiced kangaroo care were more protective and nurturing and very well bonded with their children. The children were less likely to be absent from school and less likely to have antisocial behavior.

These positive effects were still present in the children 20 years later! Now that is a simple, smart, no-cost investment in our children’s future.

Here is a video about kangaroo care from gatesnotes

WHO Kangaroo mother care: a practical guide

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FDA issues warning against laser and energy-based “vaginal rejuvenation” procedures

Despite their sudden hype and growing popularity, there is no evidence that so-called “vaginal rejuvenation” therapies are either safe or effective, the U.S. Food and Drug Administration warns in a statement today.

The procedures which use energy-based devices—laser and radiofrequency waves both, to reshape and firm the vaginal tissue claim to treat many genitourinary conditions like urinary incontinence, vaginal atrophy, and dyspareunia.

In addition to treating the above conditions, manufactures and healthcare provider also assert that it improves the sex lives of perimenopausal and menopausal women.

In the statement released on Monday FDA Commissioner, Dr. Scott Gottlieb stated, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.” 

The procedures are known to cause vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. The full extent of damage is not recognized as the devices have not been approved for “vaginal rejuvenation.”

FDA has approved and cleared these procedures for destruction of precancerous lesions of cervix and vagina and vaporization of condylomas (genital warts). But the safety and effectiveness of these devices haven’t been studied and confirmed for “vaginal rejuvenation.”

In some cases, women who have undergone treatment for breast cancer are offered these treatments under the false assertion of mitigating their symptoms of early menopause.

FDA has recently notified seven device manufacturers for concerns about the inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.

They have 30 days to address the FDA's concerns, and if they fail to do so, FDA may consider enforcement measures.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Dr. Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options," he explained.

He further advised, "Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options."

Dr. Gottlieb further assured that FDA will carefully monitor reports of problems associated with "vaginal rejuvenation" procedures and will keep the public informed.

He urged that patients who have suffered adverse effects with the use of these devices should report the complications to  MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Dr. Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical 'vaginal rejuvenation' devices are effective in improving vaginal muscle tone or reshaping vaginal tissue. If women are concerned about the appearance or feel of their vagina, they should speak to a healthcare professional. It is important to remember, however, that every woman's vagina is different. Labia are as individual as women themselves and vary in appearance and color.

"To strengthen the muscles around the vagina, women are encouraged to try pelvic floor exercises which can help to improve muscle tone and sensitivity during sex."

FDA Statement

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