FDA detains Ansell condoms from Thailand
The Food & Drug Administration (FDA) is detaining condoms manufactured by Australia-based Ansell Limited’s Surat Thani, Thailand, plant after two lots failed to meet FDA standards. If your family planning clinic carries such Ansell condom brands as LifeStyles, Mates, and Kama Sutra, what does this mean for your facility?
"We are working very hard to help ensure that this does not affect supply," says Carol Carrozza, vice president of marketing, consumer, and professional products at Ansell’s Red Bank, NJ, office. Ansell is the third-largest condom seller in the world. The United States represents its largest market for condom products.
According to Ansell, the Thailand plant made about 140 condom shipments representing more than 2,000 lots to the United States in the past fiscal year without any problems. The two lots that did not meet the standards were tested within the last seven weeks prior to Sept. 16, when the announcement was made.
All medical devices, including condoms, imported into the United States are subject to lot testing by the FDA. If the sample selected for inspection does not meet the defined standard, then the supplying plant is put on detention, with all future shipments tested until the plant is removed from detention status. For the Thailand plant to be released from detention, at least 10 successive incoming shipments will have to pass testing by the FDA prior to release into the U.S. market, according to Ansell.
The Thailand plant continues to manufacture condoms; however, every single shipment must be tested before it is released for import into the United States, says Carrozza. "There will still be product coming out of that facility that will meet or exceed the standards, and it will be tested several times by a third party before it gets into the United States," she states.
The company also is looking to its Bangalore, India, facility to help supplement some of its capacity, says Carrozza. For condom forms or shapes not stocked at the Bangalore facility, the company will subcontract manufacturing until the Thailand plant is released from detention, she adds.
What about pricing?
How will the detention measure impact pricing of condoms? Institutional purchasers of large numbers of condoms may pay as low as 4 to 6 cents per condom, according to A Pocket Guide to Managing Contraception.1 While the FDA action in itself should not contribute to an uptick in price, the condom industry is dealing with higher latex costs and increased energy bills, says Carrozza.
"Latex has gone up 34% since January 2005 and, as you can imagine, our energy costs have gone up significantly," states Carrozza. The supply situation now, because they are handling it mostly through their alternate facility in Bangalore, is that they do not see that it will have a direct impact on pricing, "but I can’t speak for some of the other implications," she says.
How about the quality of Ansell condoms in stock in the United States? Not to worry, says Carrozza; condoms in the United States passed FDA inspection and are safe for use.
While the quality of your facility’s condoms may be OK, check your condom education to make sure it is up to par. According to results of a just-published study, it is not enough to tell people to use condoms; they also need to learn how to use them correctly.2
To conduct the study, researchers interviewed more than 1,000 people visiting a sexually transmitted diseases clinic about their condom use. More than half said they had not used a condom the last time they had sex.2 When condoms were used, many said they did not squeeze air out of the tip of the condom before using it and did not hold the base of the condom during withdrawal.2
Offer patients the following condom tips:
- Before putting on the condom, check to see which way the condom unrolls. (If the male is uncircumcised, pull back foreskin before unrolling condom.)
- Unroll condom all the way down to the base of the penis (down to hair). A condom can be put onto a penis that is not fully erect.
- Smooth out air bubbles.
- Make sure the condom fits; condoms come in various sizes.
- Add water-based lubricant to outside of condom if desired.
- After sex, hold the rim of condom and carefully withdraw the penis before loss of erection.
- Check the condom for breakage. Dispose of used condom.
- If the condom breaks, slips, falls off or is not used, use emergency contraception.1
References
- Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2004.
- Grimley DM, Annang L, Houser S, et al. Prevalence of condom use errors among STD clinic patients. Am J Health Behav 2005; 29:324-330.
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