CSM Pakistan Guarantee Ltd.
has registered Sino Implant (II), a two rod Levonorgestrel
contraceptive implant in Pakistan by the brand name of Femplant
on 30th June, 2010.
Femplant has been formally launched at national level in Karachi on 2nd April, 2011 and respected Ms. Begum Shahnaz Wazir Ali (MNA & Co-chair Pakistan Education Taskforce was the chief guest at the event). Provincial launches for Baluchistan, Punjab and Sindh have been done and Femplant provincial launch for Khyber PakhtunKhwa is scheduled in November, 2011.
Marie Stopes Society and CSM conducted countrywide trainings on contraceptive Implant insertion and removal for doctors and medical trainers. The trainings are being conducted at various cities for MoH and MoPW selected resource persons and to all other interested providers.
Brief Product Overview:
Femplant is set of two flexible silicon rods, each having 75 mg of Levonorgestrel that is inserted sub-dermally on the medial aspect of the women’s upper arm using disposable Trocar. The procedure takes around 15 minutes. Femplant provides several advantages for women who want long-acting pregnancy protection. It is extremely reliable and highly effective contraceptive method, comparable in effectiveness to intrauterine devices (IUDs); and it is more effective than short-term methods. Femplant can be used by women of any age, whether they have previously given birth or not. Breastfeeding women can also use it, starting as early as six weeks after giving birth. The other major advantage of Femplant is that it is easily reversible. Fertility returns immediately after the removal of Femplant. Any undesirable side effects also disappear as soon as the implants are removed. There are no restrictions on its use for HIV-positive women.
Worldwide, this product is registered by 12 national drug regulatory authorities and is available with the brand names of Sino Implant (II), Zarin, Trust and Femplant. Dossiers are under review in several additional countries.
Femplant works primarily by:
• Thickening cervical mucus (this blocks sperm from meeting the ovum)
• Disrupting menstrual cycle, including preventing the release of ova from ovaries (ovulation)
• Changing endometrial lining
• Long Term hormonal contraceptive protection for 4 Years; protective effects are immediately reversible on removal
• Two rods; release a progestin like the natural hormone progesterone in a woman's body. Easy insertion in upper arm and removal; small flexible rods placed directly under the skin
• Possible temporary side effects - menstrual irregularities, headaches, nausea and breast tenderness
• Price Rs.1100 including disposable applicator
Benefits of Femplant
• Femplant is safe and effective for nearly all women of any age, whether they are nulliparous or multiparous.
• Femplant can be used by breastfeeding women as soon as 6 weeks postpartum.
• It is also most suitable for women who cannot use estrogen containing contraceptive, are hypertensive, smokers, anemic, or are infected with HIV.
• Femplant is easily reversible – fertility returns immediately after the removal of implants. Any undesirable side effects also disappear as soon as the implants are removed.
Quality Assurance by FHI and Shanghai Dahua:
Family Health International – FHI is among the largest and most established nonprofit organizations active in international public health and development. FHI leads a 5-year ongoing quality testing program with funding from the Bill & Melinda Gates Foundation.
• Review of existing clinical
• Laboratory testing
• Inspections of manufacturer
• Explants analysis
• Post-marketing surveillance
Shanghai Dahua Pharmaceutical, the manufacturer of Femplant also performs lot release testing on each lot for acceptability prior to distribution. Further to these, there are Independent Good Manufacturing Practices (GMP) Inspections/ audits by FHI, SGS Group and PSI.
The Quality System of the Sino-implant (II) manufacturer, Shanghai Dahua Pharmaceutical Company (known as Dahua) is certified by NQA based in UK for ISO 9001 and ISO 13485 conformity.