Controversial Implants Approved
Below is a MRR and PLR article in category Health Fitness -> subcategory Women s Issues.
FDA Approves Controversial Implants
Summary:
On July 28, 2005, the FDA lifted a 13-year ban on silicone-gel breast implants, granting Mentor Corp permission to reintroduce them to the market. This decision followed Mentor Corp's assurances that their new implants are safer and more durable than previous versions. The implants will be used under strict safety conditions set by the FDA.
Article:
On July 28, 2005, the FDA ended a 13-year ban on silicone-gel breast implants, approving Mentor Corp to reintroduce these controversial products to the market. Mentor Corp convinced the FDA that their new silicone implants offer improved safety and durability. The usage of these implants must follow rigorous safety guidelines established by the FDA:
- Patients must sign a consent form acknowledging the risks of silicone implants, including potential breakage and the need for replacement or removal.
- Silicone implants can be sold only to board-certified plastic surgeons who have completed specialized training to minimize the risk of tears and breakage.
- Mentor must maintain a registry to track long-term outcomes of implant patients.
- Patients should be informed that implant breakage may not show immediate symptoms and are advised to undergo an MRI five years post-surgery and every two years thereafter.
- Mentor is required to conduct a 10-year study to assess the breakage rate of implants.
- An independent committee must audit the implant study.
- The FDA will review the implant program in five years to ensure expected performance.
In 2004, 334,052 breast augmentations were performed in the U.S., primarily using unrestricted saline implants. With silicone implants returning, projections suggest 200,000 women might opt for them in the first year due to their more natural appearance compared to saline versions.
Silicone-gel implants were introduced in 1962 but banned in 1992 over health concerns. Research has since shown no statistical link between these implants and conditions like cancer or autoimmune diseases such as lupus. While some women claim health issues post-surgery, studies show no significant differences between women with and without implants regarding tumors or autoimmune diseases.
The most common issue is excess scar tissue around the implant, causing undesirable effects. Severe scar tissue can lead to capsular contraction, where implants become unnaturally shaped. This is more common with smooth-walled silicone implants, although saline implants can also be affected. Implants placed behind the chest muscle have a lower risk. Surgeons may manually break scar tissue, but this may damage the implant and void its warranty. Patients with contractures typically need additional surgery.
Interestingly, the asthma drug Accolate has shown potential in preventing and reversing capsular contraction, though prolonged treatment may be necessary.
Other complications include seroma (fluid accumulation), hematoma (blood collection), synmastia (fused breasts), bottoming out (implants dropping too low), double-fold (misaligned implant outline), deflation (implant rupture), tissue necrosis (localized tissue death), and infection.
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