In 2010, the FDA’s Center for Devices and Radiological Health reported that almost 300,000 breast augmentation procedures and 90,000 reconstructions with implants took place in the U.S.
About half of those procedures utilized silicone implants.
These silicone gel-filled breast implants are currently being reviewed by the FDA’s General and Plastic Surgery Devices Panel for safety and effectiveness.
It is questioned whether or not current studies on women who have silicone implants are adequate. Ways that follow-up studies should be designed and how to encourage women to get MRIs of their breasts every few years to make sure the implants have not ruptured are also being looking into regarding this matter.
Silicone implants were brought into question when women stated their implants had caused neurological and rheumatological illnesses in 1990. As a result of these complications, in 1992 the FDA requested that silicone implant manufacturers stop providing and surgeons stop using them until they could be proven as a safe product. At that time it was voted to remove silicone implants from the market, with the exception that women who have already received reconstructive surgery could continue to receive silicone implants when replacing their old ones.
In 2006, Mentor and Allergen produced two types of silicone implants for reconstruction or augmentation that the FDA approved as safe and effective devices.
Approval required that follow-up studies – the ones currently in question – are to be administered to 40,000 women who have received the silicone implants in order to test the safeness and effectiveness of the devices 10 years after they were implanted, some studies continuing on until as last as 2016.
These studies will be examined to make sure the implants are not causing any disease or reproductive problems, and that they don’t rupture. Implants that rupture or otherwise malfunction will be analyzed to determine the cause. Effectiveness of the implants will be assessed by the women’s satisfaction with the appearance of their breasts.
An early review of the 10-year data on breast implants revealed 34 cases of anaplastic large-cell lymphoma (ALCL) among women with primarily the silicone-filled type of implants. Though, the FDA addressed that the link requires confirmation, and that FDA-approved breast implants are still believed to be safe and effective devices.
In June the FDA found that a preliminary review of the follow-up data on silicone implants found no evidence that the products increase the risk of breast cancer, reproductive abnormalities, or other problems. However, agency reviewers did find some complications and that the implants often needed revision within 10 years and that the longer a woman has silicone implants the more likely she is to experience complications.
Complications include capsule contracture, reoperation, implant removal, implant rupture, wrinkling, asymmetry, scarring, and pain.
It is recommended that women with silicone gel-filled implants get a breast MRI three years after the initial surgery and every two years after to screen for ruptures, even if she is have no problems with the implants.
Participation in follow-up studies has been lower than expected, and the reviewers speculate the low numbers may impact the agency’s ability to determine if the devices are truly safe. Current discussion on this matter will cover how to improve MRI rates, whether current follow-up studies are adequate, and how to best measure safety and effectiveness of breast implants in future studies.
By: South Carolina Personal Injury Attorney Pete Strom
