FDA Still Trying To Ascertain The Long-Term Effects Of Breast Implants

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By: iStock Analyst | Sep 01, 2011 | Stocks: AGN, JNJ,

 

When the FDA approved silicone gel and saline breast implants in 2006, it did so with the condition that companies monitor and study patients for any long-term effects of the procedure. However, the two leading producers of silicone breast implants, Mentor Corporation and Allergan have reported that a large portion of women have stopped participating in the study.

Johnson & Johnson (JNJ : 64.7, -0.63) acquired Mentor Corporation in 2009 and is now part of its operating subsidiary – Ethicon Inc. Mentor Corporation has said that 79 percent of women enrolled in the study are no longer part of it. This means that since the start of the study three years ago, Mentor has preliminary data for only 21 percent of participants, much below the 65 percent that the FDA stipulated.

Allergan Inc. (AGN : 79.77, -1.12) is another pharmaceutical company that specializes in a wide range of treatments. The company is well established in the medical cosmetic industry and is the maker of the popular anti-wrinkle treatment, Botox. Allergan was able to retain 60 percent of the participants in its breast implant study over the two years that it has run.

Although the FDA has concluded that silicone and saline breast implants are safe, the original intention of this study was to study rare complications of using breast implants including its effect on breastfeeding, pregnancies, cancer, lupus and rheumatoid arthritis. Earlier this year, FDA concluded that although breast implant may be safe, they are not life-time devices and there was a higher chance of complications like hardening of the breast or rupturing of the implant taking place.

 

The latest announcement by the FDA shouldn’t affect sales of breast implants for these two companies given that no negative findings have come up from this study. Although the results may come up inconclusive if there are inadequate participants to this study, surgeons are convinced of the overall safety and effectiveness of silicone and saline breast implants and is not a big cause for concern now.

Net sales of breast aesthetics products for Allegan are expected to come in between $350 million and $360 million for the current fiscal year, and would account for roughly 7 percent of total sales. This is not a substantial part of the company’s operations and shouldn’t affect earnings too much if sales of implants slow.

Johnson & Johnson doesn’t reveal the sales of breast augmentation products, but in the second quarter of fiscal year 2011, Ethicon contributed $1.3 billion to Johnson $ Johnson’s total revenue of $16.6 billion. Again, this segment doesn’t form a large part of Johnson & Johnson’s total operations and Ethicon has a range of other products whose sales are growing.

The FDA is trying to come up with other methods to study the effect of breast implants over the long- term. One suggestion is setting up a national register to make it easier to collect data. Through the original study, the FDA intended to collect data over a period of 10 years, and a centralized registry maintained by a government agency may prove more effective.