FDA Pulls Surgical Mesh for Pelvic Organ Prolapse From the Market

The FDA has ordered all manufacturers of surgical mesh for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling their products immediately. According to the agency, the manufacturers Boston Scientific and Coloplast have not provided sufficient evidence that the benefits of these products outweigh their high, class III risks, compared with transvaginal surgical tissue repair without the use of mesh.

Women who have received transvaginal mesh for pelvic organ prolapse (POP) should continue routine care. However, if symptoms arise such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, they should promptly inform their health care providers. Patients planning a future prolapse procedure with transvaginal mesh require alternative treatments.

“In order for these mesh devices to stay on the market, we determined [in 2016] that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, stated in a news release.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheets and are absorbable, non-absorbable, or a combination of both. Animal-derived mesh are absorbable.

Source: Renal & Urology News

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Uterine fibroids

Uterine fibroids are noncancerous growths of the uterus that often appear during childbearing years. Also called leiomyomas (lie-o-my-O-muhs) or myomas, uterine fibroids aren't associated with an increased risk of uterine cancer and almost never develop into cancer.

Fibroids range in size from seedlings, undetectable by the human eye, to bulky masses that can distort and enlarge the uterus. You can have a single fibroid or multiple ones. In extreme cases, multiple fibroids can expand the uterus so much that it reaches the rib cage and can add weight.

Many women have uterine fibroids sometime during their lives. But you might not know you have uterine fibroids because they often cause no symptoms. Your doctor may discover fibroids incidentally during a pelvic exam or prenatal ultrasound.

Symptoms

Many women who have fibroids don't have any symptoms. In those that do, symptoms can be influenced by the location, size and number of fibroids.

In women who have symptoms, the most common signs and symptoms of uterine fibroids include:

·        Heavy menstrual bleeding

·        Menstrual periods lasting more than a week

·        Pelvic pressure or pain

·        Frequent urination

·        Difficulty emptying the bladder

·        Constipation

·        Backache or leg pains

Causes

Doctors don't know the cause of uterine fibroids, but research and clinical experience point to these factors:

·        Genetic changes. Many fibroids contain changes in genes that differ from those in normal uterine muscle cells.

·        Hormones. Estrogen and progesterone, two hormones that stimulate development of the uterine lining during each menstrual cycle in preparation for pregnancy, appear to promote the growth of fibroids.

Fibroids contain more estrogen and progesterone receptors than normal uterine muscle cells do. Fibroids tend to shrink after menopause due to a decrease in hormone production.

·        Other growth factors. Substances that help the body maintain tissues, such as insulin-like growth factor, may affect fibroid growth.

·        Extracellular matrix (ECM). ECM is the material that makes cells stick together, like mortar between bricks. ECM is increased in fibroids and makes them fibrous. ECM also stores growth factors and causes biologic changes in the cells themselves.

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Pediatric-Adolescent Gynecology

Gynecology is the area of medicine that specializes in diagnosing, treating, and managing conditions that affect the female reproductive organs. Our pediatric gynecology specialists provide evaluation, treatment, and support tailored to babies, children, and teens.

Our pediatric-adolescent gynecologists have advanced training to understand the unique issues that affect the development and anatomy of growing girls and young women. Our physicians take great care to examine and treat girls in a sensitive manner, and to address their specific needs. We provide specialized care through a joint effort with Children'sMedical Center in Dallas and at Legacy in Plano.

Gynecology Conditions 

Gynecologists have the expertise to treat all kinds of conditions and injuries that affect girls’ reproductive organs. Some of the issues include:

Anomalies of the reproductive organs, such as the uterus, ovaries, fallopian tubes, or cervix

Congenital (present since birth) or acquired (developed after birth) genital anomalies

Contraception

Cysts, masses, or lesions of the reproductive organs

Early or delayed puberty or sexual development

Endometriosis

Menstrual problems caused by other health conditions

Painful periods and heavy bleeding

Pelvic pain

Polycystic ovary syndrome (PCOS)

Sexually transmitted diseases (STDs), such as chlamydia, genital herpes, HIV, human papillomavirus (HPV), pelvic inflammatory disease, and syphilis

Vaginal discharge

Vaginal trauma

Vaginitis (inflammation of the vagina), yeast infections, and other infections

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Low-risk moms face fewer complications with midwives

Pregnant patients with a low risk of birth problems who are cared for by a midwife will likely leave the hospital maternity unit having experienced fewer interventions and complications than if attended by an obstetrician, a new study has concluded.

Researchers reviewed data from the medical records of more than 20,000 women with no known medical or obstetric complications. The data involved 11 Pacific Northwest hospitals and spanned 2014 to 2018. Their findings indicated that women who were attended by midwives during labor had fewer interventions such as cesarean delivery or use of an epidural. The data was collected as part of the a perinatal quality-improvement effort to gather birth data for analysis and improvement of maternal and newborn outcomes.

The UW Medicine hospitals participating in the program include the University of Washington Medical Center and Northwest Hospital & Medical Center in Seattle and Valley Medical Center in Renton. The researchers included obstetricians, certified nurse-midwives, and epidemiologists from Washington, Oregon and Canadian hospitals and universities.

The study covered 23,100 births, of which 3,816 (14%) had labor managed by midwives and 19,284  who had labor management by obstetricians. The study involved singleton births between 37 and 42 weeks with no significant medical complications. Most of the mothers (53%) were 30 to 34 years old.

“Compared with obstetricians, midwifery patients had significantly lower intervention rates,” the authors. These patients wre less likely to have artificial rupture of membranes, labor induction, episiotomy, and use of vacuum or forceps. 

The midwife patients who were giving birth for the first time had an approximately 30% lower risk of cesarean delivery, the paper said. For mothers who had previously given birth, the midwife group had a 40% lower rate of cesareans compared with the obstetrician group. There was, however.  a higher incidence of shoulder dystocia, a complication of vaginal birth, in the midwife-attended group.

For more information regarding the session on Gynecology Congress 2020 during April 27-29, 2020 at San Francisco, USA.

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Gynecologic oncology

Gynecologic oncologists offer an integrated approach to the diagnosis and surgical management of women's cancers and complex benign gynecologic diseases. These include cervical cancer, endometriosis, fibroids, ovarian cancer, pelvic masses, uterine cancer, vaginal cancer and vulvar cancer.

When you visit Mayo Clinic in Arizona, Florida or Minnesota for one of these conditions, you will benefit from the collaborative care of an integrated team of specialists. Your gynecologic oncologist works with the Mayo Clinic Cancer Center to provide leading-edge care to people who have not had success with an approved treatment. The Mayo Clinic Cancer Center is one of only 41 National Cancer Institute-designated comprehensive cancer centers in the United States and the only such program in Arizona. You will have access to the knowledge and skills of physicians and researchers in every medical specialty and, where appropriate, to clinical trials for promising treatments under investigation.

Innovative treatment options

Your doctor will talk with you about a full range of effective, innovative treatment options. Mayo Clinic gynecologic oncology surgeons are expert in complex laparoscopic and robotic approaches, fertility-sparing surgery, and risk reduction procedures for inherited cancer syndromes:

·        Advanced laparoscopic surgery. This is an effective minimally invasive technique that has been shown to result in shorter hospital stays, less discomfort and a shorter recovery period.

·        Robotic surgery. This approach has the same advantages as advanced laparoscopy, and it allows surgeons to operate with increased precision and accuracy while minimizing trauma to surrounding tissues.

·        Intraoperative radiation therapy (IORT). This radiation technique is used to treat advanced cancers that are localized but have spread from the original tumor site in people who might otherwise have no treatment options. In IORT, the equipment is brought directly into the operating room, and a high dose of radiation is administered directly to the cancer site during surgery. Mayo Clinic is one of only about 10 medical centers in the world offering this treatment option.

Intraperitonealchemotherapy. This technique involves the direct delivery of chemotherapy into the abdomen for treatment of ovarian cancer. National Cancer 
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MATERNAL-FETAL MEDICINE

The Society for Maternal-Fetal (SMFM) released the following statement in response to the published results of "Progestin's Role in Optimizing Neonatal Gestation," more commonly referred to as the PROLONG trial, which was recently published in the American Journal of Perinatology.

The PROLONG trial assessed the effectiveness of weekly injections of 17-alpha-hydroxyprogesterone caproate (17-OHPC) in reducing the incidence of recurrent preterm birth and neonatal morbidity. Between 2009 and 2018, this study enrolled more than 1,700 pregnant patients from nine countries and ultimately concluded that 17-OHPC does not decrease recurrent preterm birth or neonatal morbidity.

A previous large randomized control trial (Meis, 2003) also examined the effectiveness of 17-OHPC. Unlike PROLONG, this study found a 34% reduction in the incidence of recurrent preterm birth and significant reductions in several neonatal complications.

In comparing the conflicting results of the PROLONG and Meis trials, one important consideration is the different populations studied. The Meis trial included a larger proportion of patients with additional risk factors for preterm birth. For example, 20% of the patients in the Meis trial reported smoking, compared to 8% in the PROLONG Trial. Other meaningful differences in the populations included:

• Race/Ethnicity
• Number of previous preterm births
• Marital status
• Reported substance use

·        SMFM has reviewed the results of the PROLONG trial and has released the SMFM Statement: Use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth, which recommends that obstetric care providers use an individualized approach as they council patients regarding the use of 17-OHPC. It is reasonable for providers to continue to use 17-OHPC in the context of a shared decision-making model that includes consideration of risk level for recurrent PTB. Important factors to discuss include: uncertainly regarding the benefit, the lack of short-term safety concerns, the possibility of injection site pain, extra patient visits, and substantial costs.

·        Further, SMFM recommends additional research on 17-OHPC to identify populations in whom it is likely to be effective.

·        SMFM's complete, updated clinical guidance will be published in the American Journal of Obstetrics and Gynecology, can be found on the SMFM website, and will be addressed on Tuesday, October 29, 2019 at meeting of the Food and Drug Administration's Bone, Reproductive and Urologic Drugs Advisory Committee.

Source: News Medical Life Sciences

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PREGNANCY

Pregnancy, also known as gestation, is the time during which one or more offspring develops inside a woman. A multiple pregnancy involves more than one offspring, such as with twins. Pregnancy can occur by sexual intercourse or assisted reproductive technology. A pregnancy may end in a live birth, abortion, or miscarriage, though access to safe abortion care varies globally. Childbirth typically occurs around 40 weeks from the start of the last menstrual period (LMP). This is just over nine months, where each month averages 31 days. When measured from fertilization it is about 38 weeks. An embryo is the developing offspring during the first eight weeks following fertilization, after which, the term fetus is used until birth. Symptoms of early pregnancy may include missed periods, tender breasts, nausea and vomiting, hunger, and frequent urination. Pregnancy may be confirmed with a pregnancy test.

Pregnancy is divided into three trimesters. The first trimester is from week one through 12 and includes conception, which is when the sperm fertilizes the egg. The fertilized egg then travels down the fallopian tube and attaches to the inside of the uterus, where it begins to form the embryo and placenta. During the first trimester, the possibility of miscarriage (natural death of embryo or fetus) is at its highest. The second trimester is from week 13 through 28. Around the middle of the second trimester, movement of the fetus may be felt. At 28 weeks, more than 90% of babies can survive outside of the uterus if provided with high-quality medical care. The third trimester is from 29 weeks through 40 weeks.

Prenatal care improves pregnancy outcomes. Prenatal care may include taking extra folic acid, avoiding drugs and alcohol, regular exercise, blood tests, and regular physical examinations. Complications of pregnancy may include disorders of high blood pressure, gestational diabetes, iron-deficiency anemia, and severe nausea and vomiting among others. In the ideal childbirth labor begins on its own when a woman is "at term".Babies born before 37 weeks are "preterm" and at higher risk of health problems such as cerebral palsy. Babies born between weeks 37 and 39 are considered "early term" while those born between weeks 39 and 41 are considered "full term". Babies born between weeks 41 and 42 weeks are considered "late term" while after 42 week they are considered "post term". Delivery before 39 weeks by labor induction or caesarean section is not recommended unless required for other medical reasons.

For more information regarding the session on Gynecology Congress 2020 at San Francisco, USA During April 27-29, 2020

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