Contraception Causes Alarm

December 14, 2017

There are growing fears about serious side-effects from two popular contraceptive devices on the market with claims they are being glossed over by pharmaceutical companies, according to a report on ABC radio.

An ABC investigation has found women around the country are reporting serious concerns about the Implanon hormonal arm implant and Mirena intra-uterine devices.

The ABC’s National Reporting Team’s Alison Branley and medical reporter Sophie Scott, reported the women’s concerns include chronic pain, pelvic inflammatory disease, serious scarring and depression.

The article said of more than 945,000 Implanon devices inserted in Australia over the past decade the Therapeutic Goods Administration has received more than 1,000 reports from treating doctors and specialists of side-effects and other problems.

These include more than 500 unintended pregnancies, more than 50 vaginal haemorrhages and 27 ectopic pregnancies.

Of more than 967,000 Mirenas implanted in the past decade the Therapeutic Goods Administration has received more than 850 reports of adverse effects.

These include 70 pregnancies and more than 100 uterus perforations.

Affected women have told the ABC when they have asked to have the devices removed some doctors have resisted because they believe patients adapt to the hormones and most side-effects subside.

The products are known as long-acting reversible contraceptives, or LARCs, and have been growing in popularity in recent years.

Unlike traditional contraceptive pills, these devices are often still under patent and do not have any competition.

The ABC has found pharmaceutical companies have been waging massive marketing campaigns to promote the devices.

It includes paying key opinion leaders for consultancy work, sponsoring educational events for advocacy groups, general practitioners and specialists and getting favourable press through health forums.

As recently as September 2017, the major industry group representing hospitals, the Australian Healthcare and Hospitals Association, issued a public statement they called a “Consensus Statement” on the use of LARCs for World Contraceptive Day.

It stated a number of goals including reducing unplanned pregnancies by, “increased access to long-acting reversible contraceptive methods”.

The statement was backed the College of Midwives, Nurse Practitioners, the Royal Australian New Zealand College of Obstetricians and Gynaecologists, Family Planning NSW, Health Consumers Council and even Marie Stopes Australia.

At the end of the statement the association disclosed it was, “supported by the funding from Merck Sharp & Dohme (MSD)” and developed during a health forum where MSD and Bayer Pharmaceuticals were participants.

MSD makes one of the major Long Acting Reversible Contraceptives on the market — Implanon. Bayer makes the other major device, Mirena.

The statement came despite most experts conceding contraceptive choice was highly individual.

When the ABC questioned the Australian Healthcare and Hospitals Association, it agreed it was a personal choice but added the statement was about reflecting “systemic factors” that prevented women learning about the devices, not influencing doctors.

Implanon was not the answer for mother-of-four Suzie Short.

She had just had her first baby when her GP suggested she have the implant, which lasts three years, in her arm.

“Probably about two months after, I started bleeding non-stop,” she said.

“All up it was seven months straight pretty much that I bled.”

Ms Short was so lethargic she could not care for her infant daughter and said she believed her body reacted to the progesterone in the implant that prevents ovulation.

Many years later she is still struggling from side-effects and attributes them to the device.

“I’ve now got chronic pelvic pain due to adhesions, all of my abdominal organs are fusing to my abdominal wall, I’ve had pelvic inflammatory disease, I’ve had an abscess in my right fallopian tube,” she said.

Ms Short is also on anti-depressants and resents the impact the medication has had on her ability to parent.

She is a member of a Facebook page of more than 700 women who say they’ve suffered serious side-effects from Implanon, including serious scarring after removals.

In a statement a spokeswoman for Implanon’s maker Merck, Sharpe and Dohme told the ABC: “The approved Product Information for Implanon provides guidance on appropriate use in suitable patients.”

“Patients should speak to their healthcare professional about their contraceptive options,” she said.

Implanon is not the only device under the spotlight.

More than 700 Australian women are in support group for fallout from a hormone-release intra-uterine device called a Mirena, which lasts five years.

Mother-of-three Jane Morgan-Harry was lying in hospital after a miscarriage when her doctor suggested she try a Mirena.

Ms Morgan-Harry said she had asked to have her tubes tied but her doctor had just returned from a medical conference on the device.

“My state of mind was I didn’t want to have to go through what I’d just gone through,” she said.

After the procedure Ms Morgan-Harry knew she had made a mistake.

“So, day one, severe cramping, the bleeding was bad,” she said.

“I had headaches, sweats, the shakes, nausea continuously pretty much 24 hours a day.

“Honestly sometimes the hormones are like I’m going through menopause.”

She claims the impact on her mental health meant she had to take anti-anxiety medication for the first time in her life.

Ms Morgan-Harry spent months trying to get a doctor to listen to her and agree to remove it.

“The response was pretty much I was making it up, that it can’t be from the Mirena,” she said.

Her period now lasts for two weeks each month but she will have to wait more than a year to have the device removed in a public hospital.

In a statement Bayer, the makers of Mirena, said millions of women worldwide had used the device, “But like any prescription product, Mirena has risks and benefits”.

“We investigate reports on side-effects thoroughly and collaborate closely with the Therapeutic Goods Administration concerning the use, benefits and risks of all products,” a spokeswoman said.

For a long time the main two players in the market for traditional contraceptive pills have been pharmaceutical giants Bayer and Pfizer.

But in recent years they’ve had extra competition from the generic market.

So now the main players are increasingly focusing their attention on Long-Acting Reversible Contraceptives or LARCs.

Bayer makes Mirena, MSD make Implanon and Pfizer make long-acting contraceptive injections, commonly known as Depo-Provera.

All three companies have been spending up big as they jockey for market share.

“The fact that there was some financial support from the manufacturer has not influenced the information.”

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