Pelvic mesh implant patients want answers from Senate report

ABC 730 report, 26/3/2018

A steady stream of Australian women with pelvic mesh implants have spent tens of thousands of dollars flying to a clinic in Missouri to have their implants removed, claiming they have suffered major side-effects from the implants used to treat prolapse and incontinence.

More than 35 Australian women have made the journey to the same practitioner because, they say, they don’t have faith in Australian surgeons to carry out a full removal of their implant.

The claim that Australia does not have the expertise is rejected by both the Australian Medical Association (AMA) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG).

 

 

SHINE SA Media Release: Response to the call to ban Diane-35

SHINE SA, issued 13th December 2017

SHINE SA believes everyone should have access to contraceptive choices, and that decisions about contraception are best made in conjunction with a healthcare professional.

Cyproterone acetate pills, commonly known as Diane-35 appear to be associated with a higher risk of deep venous thrombosis (DVT) than levonorgestrel (LNG) containing pills, although the overall risk is still very low for most people.

For those who choose combined pills, we recommend as first choice the pills with lowest risk: those containing levonorgestrel or norethisterone as their progesterone. However, the other progestogen choices, which all carry a small increased risk of DVT compared to LNG, may be utilised if specific added benefits are required. Health professionals can review over time the experience individuals may have with their contraceptive choice.

Cyproterone acetate can be used as treatment for signs of androgenisation in people such as severe acne (involving inflammation or nodularity, or risk of scarring) where prolonged oral antibiotics or local treatment alone have not been successful, or idiopathic hirsutism of mild to moderate degree. The oral contraceptive pill containing cyproterone acetate can also provide effective oral contraception in this patient group.
People who have concerns should seek advice from their doctor before stopping their oral contraceptive pill.

Download Media release (PDF): Response to the call to ban Diane-35 SHINE SA Diane35_13 Dec 17_FS

 

SHINE SA Media Release: Response to ABC report on Long Acting Reversible Contraception (LARCs)

SHINE SA, Issued: 13 December 2017

SHINE SA believes that decisions about contraception should be made in conjunction with a health care professional and that everyone should have access to accurate and unbiased information to enable appropriate informed contraceptive choice.

LARCs (Long Acting Reversible Contraception) including the levonorgestrel IUD1 (Mirena) and the subdermal implant (Implanon NXT) are the most effective reversible methods of contraception available. They have the additional advantage of being long lasting, convenient to use and generally well regarded by most users. LARC method failure rates rival that of tubal sterilization at <1% and unintended pregnancy rates are lower than those reported for contraceptive pill users.

Like all progestogen only contraceptive methods, LARCs may result in a change of bleeding pattern which may include no bleeding, frequent or prolonged bleeding. Users of the levonorgestrel IUD most commonly experience a reduction in bleeding over time and it is used as a treatment for Heavy Menstrual Bleeding for this reason. Only 1 in 5 users of the contraceptive implant have an increase in bleeding that persists beyond the first few months.

LARC use, and in particular the subdermal implant, is not known to be associated with pelvic inflammatory disease (PID) which is an infection of the upper part of the female reproductive system namely the uterus, fallopian tubes, and ovaries. PID is a known side effect of IUD insertion but occurs in less than 1 in 300 people. The risk of PID is only increased for the first 3 weeks after insertion, after which it returns to the previous background risk. Users of IUDs are encourage to return at any sign of infection and when treated promptly with antibiotics are unlikely to experience any long term complications.

Safety of Medical Abortion Provided Through Telemedicine Compared With in Person

Obstetrics & Gynecology, September 05, 2017
doi: 10.1097/AOG.0000000000002212

ABSTRACT:

OBJECTIVE: To compare the proportion of medical abortions with a clinically significant adverse event among telemedicine and in-person patients at a clinic system in Iowa during the first 7 years of the service.

METHODS: We conducted a retrospective cohort study. We analyzed data on clinically significant adverse events (hospital admission, surgery, blood transfusion, emergency department treatment, and death) for all medical abortions performed by telemedicine or in person at a clinic system in Iowa between July 1, 2008, and June 30, 2015. Data on adverse events came from required reporting forms submitted to the mifepristone distributor. We calculated the prevalence of adverse events and 95% CIs comparing telemedicine with in-person patients. The analysis was designed as a noninferiority study. Assuming the prevalence of adverse events to be 0.3%, telemedicine provision was considered to be inferior to in-person provision if the prevalence were 0.6% or higher. The required sample size was 6,984 in each group (one-sided [alpha]=0.025, power 90%). To explore whether patients with adverse events presented to emergency departments and were not reported, we conducted a survey of the 119 emergency departments in Iowa, asking whether they had treated a woman with an adverse event in the prior year.

RESULTS: During the study period, 8,765 telemedicine and 10,405 in-person medical abortions were performed. Forty-nine clinically significant adverse events were reported (no deaths or surgery; 0.18% of telemedicine patients with any adverse event [95% CI 0.11-0.29%] and 0.32% of in-person patients [95% CI 0.23-0.45%]). The difference in adverse event prevalence was 0.13% (95% CI -0.01% to 0.28%, P=.07). Forty-two emergency departments responded to the survey (35% response rate); none reported treating a woman with an adverse event after medical abortion.

CONCLUSION: Adverse events are rare with medical abortion, and telemedicine provision is noninferior to in-person provision with regard to clinically significant adverse events.

Essure contraceptive device: Hazard Alert from TGA

Therapeutic Goods Administration, August 30, 2017

Consumers and health professionals are advised that Australasian Medical and Science Ltd (AMSL), in consultation with the TGA, has issued a hazard alert for Essure. AMSL is also recallingunused stock and withdrawing the device from the Australian market.

The battle over Essure

The Washington Post, Published on July 26, 2017

Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.” 

In recent years, the [US] Food and Drug Administration has received more than 16,000 adverse-event reports about Essure. These are official reports about symptoms, hospitalizations or diagnoses that patients, doctors, hospitals or a device manufacturer believe are associated with a device.

“It seems every two or three years we have another controversy in women’s health,” says Steve Xu, a health-­policy researcher and Northwestern University dermatology resident.