After reviewing the data from several long term studies, the Food and Drug Administration has come to a conclusion that breast implants do not last a lifetime.
Breast implants do not last a lifetimeMost of the women who have got silicone breast implants are likely to have another surgery within ten years to address problems arising out of the implants.
The FDA gave approval to Allergan’s Inamed and Johnson & Johnson’s Mentor to manufacture silicone breast implants in November 2006. At that time, the FDA had asked both the manufacturers to conduct large post approval studies including about 40,000 women each, for ten years after they had received breast implants. The purpose of these post approval studies was to address issues that arise only after a broad use of the product. Allergan collected preliminary data of two years from 60% of the women who received its implants whereas Mentor collected three year data from 20% women. After reviewing the data collected from the studies so far, the FDA has found that many women who had received breast implants had to undergo reconstructive surgeries.
Statistics show that almost 70% of the women who had implants on account of disease or trauma and almost 40% of women who had implants as an enlargement procedure, needed another operation within 10 years.
But a high level of dropout rates from the studies has laid a question mark over the authenticity of the results and on the efficacy of post approval studies.
Important points to be considered before getting Breast ImplantsSilicone breast implants have been associated with complications like asymmetry, breast tissue atrophy, calcification, leakage or rupture of the capsule, capsular contracture, hematoma, infection, implant displacement, deflation, etc. In rare circumstances, silicone breast implants have been associated with the development of anaplastic large cell lymphoma (ALCL), a rare form of cancer affecting 3,000 Americans every year. There were 60 cases of this cancer, in about 5 million to 10 million women who had breast implants between 1997 and 2010. These complications may warrant the need of another operation.
In view of these complications, the FDA has recommended certain points that should be kept in mind before opting for a breast augmentation, reconstruction or revision surgery. They are:
• Breast implants do not last a lifetime. The longer you have had the implants, the more likely are the chances of local complications leading to additional surgeries.
• There are more chances of your getting the implants removed if the implant has been there for a long time.
• You should be aware of the complications like, wrinkling, asymmetry, scarring, pain, infection at incision site, deflation and capsular contracture before heading for a breast implant.
• You should be prepared for additional surgeries that may be required later.
• You should keep in mind that many changes in the breast following an implant surgery may be aesthetically unappealing and irreversible.
• In case you opt for implant removal instead of implant replacement, your natural breast tissue may undergo dimpling, puckering, wrinkling and shrinkage.
• You’ll have to monitor your breasts regularly following an implant. This may include periodic MRIs to detect rupture and may be pretty expensive.
• In the rare circumstance of developing ALCL, the patient may have to undergo surgery, chemo/ radiation therapy.