Proposed regulations from the federal Food and Drug Administration address problems with breast implants and call for more frequent screening, beginning at 5-6 years after surgery and every 2 years after that, for women with the devices.
Following testimony by women last spring about problems caused by breast implants, the FDA will require new warning labels on the devices, and defines risks and problems with them. The public has 60 days to comment on the new regulations. Here’s how to comment and the FDA notice issued today:
Take-home messages for women from a 2-day meeting of a federal advisory committee, March 25-26, 2019. The first public hearings in nearly 20 years on breast implants, they follow growing reports about problems women experienced from certain types of breast implants.
1. Talk to your plastic surgeon before your surgery about all your choices. Ask for both condensed and complete patient handbooks on the risks and benefits of your choice. 2. If you are choosing to have breast implants _ as do 9 of 10 women undergoing breast reconstruction _ consider smooth rather than textured implants. Textured implants are associated with rare but serious cases of lymphoma, a possibly fatal type of cancer with a range of debilitating illnesses. 3. Ask your plastic surgeon if she/he is using a mesh product, also called ADM (acellular dermal matrix) used in 80 percent of breast reconstructions to improve the look and provide better support of an implant. These products increase the risk of surgical complications by 43%, according to a University of Michigan study, and may require more surgery. These products are not federally-approved but have been used off-label for years. Now some surgeons are rethinking whether to use them. 4. Ask your plastic surgeon if the implant will be placed below or above the muscle in the chest. Mesh/ADM products almost always are used when an implant is placed above the muscle, so-called pre-pectoral placement, but also are common when an implant is place under the muscle. Placing an implant above the muscle has grown in use to avoid having the implant move around, a problem known as distortion. But it always requires an ADM product. These findings may force plastic surgeons to return to placing implants under the muscle, as they did for years. 5. If you don’t understand anything, ask your plastic surgeon questions. Take a friend you trust to your pre-surgery consult. The best plastic surgeons work with you to answer your questions and don’t limit you to a 7-minute encounter. 6. Get a card and save information about the exact type of implant you receive. 7. Even if you have no problems, get mammograms or ultrasound tests to be sure your implants aren’t leaking silicone, a problem known as silent rupture. If you have any symptoms, get an MRI to be sure your implants aren’t leaking. 8. Report any problems to your plastic surgeon and ask that the problems be reported to a registry, so the FDA and the manufacturer have complete information about implant complications. 9. If you have problems, consider taking out the implants, as most women report feeling much better, often immediately, once their implants are removed. 10. If you want reconstruction, initially or after explant removal, consider autologous procedures that transfer tissue and tiny blood vessels from your abdomen, butt or thighs to make a breast. These procedures are more difficult; aren’t offered by most plastic surgeons, as they aren’t trained in these advanced techniques; and take more recovery time. But they are associated with fewer problems and can last a life-time.
Compiled by Patricia Anstett, author, “Breast Cancer Surgery and Reconstruction: What’s Right for You,’’ and administrator of a companion website, bcsurgerystories.com, and Facebook page. Anstett, a former Detroit Free Press Medical Writer, covered the FDA breast implant hearings nearly 20 years ago.
See this link https://www.facebook.com/groups/295420417294192/to follow latest developments about two days of hearings by FDA on breast implants. Key issues include risk of lymphoma from certain types of breast implants; improvement of followup of patients with breast implants; and model practices regarding patient consent.
Increasingly, doctors are placing breast implants over not under the muscle for women who are thinner, very active and athletic, to minimize a problem called distortion when the implants move around. We address this issue in our book; some doctors, however, say that positioning implants over the muscle gives a more unnatural look. If you are a weight lifter, boxer or very athletic, thinner woman considering implants, this is an important issue to discuss with your plastic surgeon.
Where to place breast implants — under the chest muscle or over it — remains more a plastic surgeon’s choice. It’s an important discussion, in particular, for thinner, very active women, who sometimes complain that implants move inappropriately when they exercise. In plastic surgery, this is an issue known as “distortion.”
Here one doctor provides some clarity on why he and many other doctors prefer to place implants under the chest muscle. https://niume.com/post/247372https://niume.com/post/247372.
For more discussion on implant placement, see our book’s breast implant chapter. It discusses types of implants; problems; placement concerns and other issues.
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