Breast Implant Helpline keeps you updated on all breast implant news. Years after the Dow Corning Silicone Breast Implant disaster a new silicone breast implant hits the market. The FDA has approved a new silicone gel breast implant from Johnson & Johnson.
Next Generation breast Implant?
The Food and Drug Administration said it has approved a next-generation silicone breast implant from Mentor, a unit of New Brunswick-based Johnson & Johnson. Ladies let’s remember who this is. The same folks that bring you the vaginal mesh implant that is ruing lives nationwide. We watch with skepticism. The company’s MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants. FDA regulators approved the new implant for breast enhancement and reconstruction in women at least 22 years old.
Can Silicone Breast Implants Make A Comeback?
Silicone gel implants have made a comeback recently after safety concerns kept them off the market for nearly 25 years.
The FDA banned sales of silicone breast implants in 1992, saying manufacturers had not provided enough medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern. Women are still waiting on settlements from the Dow Corning Class Actions and a new breast implant explant program has been announced.
The FDA said Friday it approved Mentor’s new implant based on studies tracking six years of data in 955 women. The agency said complications with Mentor’s MemoryShape implants were similar to those from previously approved silicone gel implants.
FDA is requiring Mentor to meet a number of requirements in connection with the new approval, including:
• Tracking the 955 women with the new implant
• Conducting a new study of 2,500 women who receive the new implant
• Evaluating women’s comprehension and perception of the implant’s labeling
• Analyzing any implants that are removed from women and returned to the manufacturer
More than one in five women who get implants for breast enhancement will need to have them replaced within five years, accord to an FDA analysis of company data released in 2011. Despite that relatively high failure rate, FDA regulators concluded that the silicone-gel implants are basically safe, as long as women understand they come with complications. Some critics of the implants say the failure rate may be even higher, since many women have dropped out of the company studies.
We will be watching.
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